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    Array BioPharma....ein Übernahmekandidat? - 500 Beiträge pro Seite

    eröffnet am 29.11.16 23:23:58 von
    neuester Beitrag 17.07.19 22:37:31 von
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      Avatar
      schrieb am 29.11.16 23:23:58
      Beitrag Nr. 1 ()
      Array (Nasdaq: ARRY) hat eine beeindruckende Pipeline - es würde mich nicht wundern, wenn BigPharma sich diese nicht einverleiben würde:

      http://www.arraybiopharma.com/product-pipeline/
      4 Antworten
      Avatar
      schrieb am 29.11.16 23:27:49
      Beitrag Nr. 2 ()
      Antwort auf Beitrag Nr.: 53.796.180 von Cyberhexe am 29.11.16 23:23:58
      Zitat von Cyberhexe: Array (Nasdaq: ARRY) hat eine beeindruckende Pipeline - es würde mich nicht wundern, wenn BigPharma sich diese nicht einverleiben würde:

      http://www.arraybiopharma.com/product-pipeline/



      sorry, das ging daneben....gemeint ist natürlich, dass ich mich nicht wundern würde, wenn BigPharma sich diese viel versprechende Pipeline einverleiben würde.

      :keks:
      3 Antworten
      Avatar
      schrieb am 20.02.17 19:26:09
      Beitrag Nr. 3 ()
      Antwort auf Beitrag Nr.: 53.796.189 von Cyberhexe am 29.11.16 23:27:49Freddy, du hast dich nach meinen Tipps für 2017 erkundigt: einer davon ist ARRY


      Pipeline:
      http://www.arraybiopharma.com/product-pipeline/


      ausgezeichnete Ergebnisse in COLUMBUS:

      COLUMBUS Phase 3 Study Results in BRAF-Mutant Melanoma Presented at Society for Melanoma Research Annual Congress
      - Binimetinib plus encorafenib meets primary endpoint with statistically significant advantage on median PFS of 14.9 months versus 7.3 months for vemurafenib monotherapy -
      - Additional PFS, ORR and durability data support primary endpoint result -
      - Detailed safety and drug exposure data presented; combination of binimetinib plus encorafenib demonstrates a favorable tolerability profile -
      BOULDER, Colo., and CASTRES, France, Nov. 9, 2016 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) and Pierre Fabre today jointly announced new results from the pivotal Phase 3 COLUMBUS trial of binimetinib plus encorafenib (bini/enco) treatment in BRAF-mutant melanoma patients at the Society for Melanoma Research Annual Congress. The study met its primary endpoint, with the combination of bini/enco significantly improving progression free survival (PFS) compared with vemurafenib, a BRAF inhibitor, alone. The combination of bini/enco was generally well-tolerated and reported adverse events (AEs) were overall consistent with previous published clinical trial results for the bini/enco combination in BRAF-mutant melanoma patients.


      Einstiegskurs/Empfehlungskurs am 29.11.2016 USD 8.23
      2 Antworten
      Avatar
      schrieb am 28.02.17 08:58:11
      Beitrag Nr. 4 ()
      Antwort auf Beitrag Nr.: 54.367.383 von Cyberhexe am 20.02.17 19:26:09Die Zulassungsentscheidung von Binimetinib zur Behandlung von NRAS-mutiertem Hautkrebs rückt näher.
      Die Zeichen stehen auf Zulassung.


      In September 2016, Array announced that the FDA has accepted its NDA for binimetinib with a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2017. Array completed its NDA submission of binimetinib in late June 2016 based on findings from the pivotal Phase 3 NEMO trial in patients with NRAS-mutant melanoma

      http://www.arraybiopharma.com/product-pipeline/binimetinib/
      Avatar
      schrieb am 02.03.17 13:38:27
      Beitrag Nr. 5 ()
      Array BioPharma To Present At The Cowen And Company Annual Healthcare Conference


      BOULDER, Colo., March 1, 2017 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced that its Chief Executive Officer, Ron Squarer, will present at the Cowen and Company Annual Healthcare Conference in Boston. The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

      Event:
      Cowen and Company Annual Healthcare Conference

      Presenter:
      Ron Squarer, Chief Executive Officer

      Date:
      Wednesday, March 8, 2017

      Time:
      10:00 a.m. Eastern Time

      Webcast:
      http://wsw.com/webcast/cowen38/arry

      http://finance.yahoo.com/news/array-biopharma-present-cowen-…

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      Avatar
      schrieb am 08.03.17 10:23:32
      Beitrag Nr. 6 ()


      Nach einem neuen Tweet des US-Präsidenten sind die Aktien von Pharmawerte unter Druck geraten. Auch mehrere Schweizer Firmen notieren tiefer. Donald Trump will die Preise für Medikamente senken.

      US-Präsident Donald Trump hat der Pharmabranche am Dienstagnachmittag einen kleinen Dämpfer versetzt. Er arbeite an einem Plan, der den Wettbewerb in der Pharmaindustrie fördern und die Preise für Medikamente senken werde, verbreitete Trump via Twitter.
      Die Partei von Trump hat einen Gesetzentwurf zur Abschaffung von Barack Obamas Gesundheitsreform vorgelegt. Trump liess die Öffentlichkeit wissen, dass er den Wettbewerb im Pharmabereich stärken wolle. Die Preise für amerikanische Konsumenten sollen sinken.


      http://www.handelszeitung.ch/invest/trump-twittert-novartis-…" target="_blank" rel="nofollow ugc noopener">
      http://www.handelszeitung.ch/invest/trump-twittert-novartis-…
      Avatar
      schrieb am 20.03.17 10:15:01
      Beitrag Nr. 7 ()
      Array BioPharma Provides NEMO Update
      - NRAS-mutant melanoma NDA withdrawn based on thorough discussions with FDA and following late cycle review meeting -

      - Ongoing binimetinib clinical studies will continue; withdrawal will not impact planned COLUMBUS NDA submission of binimetinib, in combination with encorafenib, for BRAF-mutant melanoma expected in mid-2017 -

      BOULDER, Colo., March 19, 2017 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) today announced that it has withdrawn from the U.S. Food and Drug Administration's (FDA) Division of Oncology Products 2 its new drug application (NDA) for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer.

      This action was based on thorough discussions and communications with the FDA, including exploration of various paths to approval, and followed the late cycle review meeting held with the FDA on Friday, March 17, 2017. Based on feedback from the agency, Array concluded that the clinical benefit demonstrated in the Phase 3 NEMO clinical trial would not be found sufficient to support approval of the NRAS-mutant melanoma NDA.

      Ongoing clinical trials for binimetinib will continue. This action will not impact the planned Phase 3 COLUMBUS trial NDA of binimetinib, in combination with encorafenib, for the treatment of BRAF-mutant melanoma, which remains on track for mid-2017.

      - See more at: http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=…
      3 Antworten
      Avatar
      schrieb am 20.03.17 11:49:46
      Beitrag Nr. 8 ()
      Antwort auf Beitrag Nr.: 54.569.130 von bernie55 am 20.03.17 10:15:01Ongoing binimetinib clinical studies will continue

      Withdrawal will not impact planned COLUMBUS NDA submission of binimetinib, in combination with encorafenib, for BRAF-mutant melanoma expected in mid-2017 -


      Die Kurse sind teilweise vorbörslich runter bis auf 6,55 $ - irgendwie kann ich diese panische Überreaktion nicht begreifen.

      Das Projekt ( NEMO) für Binimetinib als Monotherapie wird nicht weiter durchgeführt - OK

      Aber davon wird das Ergebnis der COLUMBUS Kombitherapie von Binimetineb und Encorafenib , wie oben bereits geschrieben, nicht beeinflusst.

      Ich habe heute unter 6,30 € nochmal ordentlich nachgekauft.

      Grüße
      bernie55 ;)
      2 Antworten
      Avatar
      schrieb am 20.03.17 12:38:37
      Beitrag Nr. 9 ()
      Antwort auf Beitrag Nr.: 54.569.754 von bernie55 am 20.03.17 11:49:46
      Zitat von bernie55: Die Kurse sind teilweise vorbörslich runter bis auf 6,55 $ - irgendwie kann ich diese panische Überreaktion nicht begreifen.


      Ich habe heute unter 6,30 € nochmal ordentlich nachgekauft.

      Grüße
      bernie55 ;)


      Vorbörslich aktuell in den USA wieder um die 9$ :cool:
      1 Antwort
      Avatar
      schrieb am 20.03.17 12:47:59
      Beitrag Nr. 10 ()
      Antwort auf Beitrag Nr.: 54.570.129 von bernie55 am 20.03.17 12:38:37Der Blick auf den vorbörslichen Tageschart

      Avatar
      schrieb am 28.04.17 11:38:26
      Beitrag Nr. 11 ()
      Shalini Sharp Joins Array BioPharma Board of Directors

      BOULDER, Colo., April 27, 2017 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced that Shalini Sharp, Chief Financial Officer and Executive Vice President of Ultragenyx Pharmaceutical Inc., joined the company's Board of Directors, effective April 27, 2017.
      Ms. Sharp has been appointed to the Audit Committee of the Board.

      Ms. Sharp has served as Chief Financial Officer of Ultragenyx, a biopharmaceutical company focused on rare diseases, since 2012, where she is responsible for leading the corporate finance, strategy, and information technology functions and is a member of the company's executive leadership team. Ms. Sharp brings nearly 20 years of experience in the life sciences industry.

      Ron Squarer, Chief Executive Officer of Array, noted, "Shalini has an ideal background to complement the expertise of our Board of Directors. Her financial leadership at healthcare organizations will be invaluable as we focus our efforts in oncology and prepare for commercialization." >>> Schon ein gutes Omen bzgl. COLUMBUS ??? <<<

      Ms. Sharp added, "Array has built an impressive development pipeline of therapeutics that is advancing in late-stage clinical trials and provides the opportunity to significantly benefit patients in areas of unmet need. I'm excited to join the company's Board at such an important time in its history, as it nears commercialization of its drugs. I look forward to working with Ron and my fellow Board members through this important evolution of Array."

      Ms. Sharp is also a member of the Board of Directors of Agenus Inc. (formerly Antigenics Inc.), a publicly traded immuno-oncology company, where she served as Chief Financial Officer from 2006 to 2012. She joined Agenus in 2003 and held increasing roles of responsibility spanning strategic planning, corporate development, investor relations, corporate finance and business development. She is also a member of the Board of Directors of the TB Alliance, a non-profit organization dedicated to the development and distribution of treatments for tuberculosis in the developing world. Prior to Agenus, Ms. Sharp held similar roles at Elan Pharmaceuticals from 1998 to 2003, including serving as chief of staff to the Chairman of the Board of Directors during that company's restructuring. She has spearheaded numerous financing and business development transactions that were critical to the success of Agenus and Elan. Ms. Sharp was also a management consultant at McKinsey & Company as well as an investment banker at Goldman Sachs, specializing in pharmaceuticals and medical devices. Ms. Sharp holds both a B.A., magna cum laude, and a M.B.A. from Harvard University.

      Ms. Sharp will serve as a Class II director on the Board with a term that expires at the Annual Meeting of Array's stockholders in 2017.

      https://finance.yahoo.com/news/shalini-sharp-joins-array-bio…
      Avatar
      schrieb am 04.05.17 10:36:17
      Beitrag Nr. 12 ()
      Array Biopharma To Report Financial Results For The Third Quarter Of Fiscal 2017 - On May 10, 2017

      BOULDER, Colo., May 3, 2017 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) will report financial results for the third quarter of fiscal 2017 and hold a conference call to discuss those results on Wednesday, May 10, 2017. Ron Squarer, Chief Executive Officer, will lead the call.

      Date:
      Wednesday, May 10, 2017


      Time:
      9:00 a.m. Eastern Time


      Toll-Free:
      (844) 464-3927
      Toll:
      (765) 507-2598
      Pass Code:
      92608803


      https://finance.yahoo.com/news/array-biopharma-report-financ…
      Avatar
      schrieb am 09.05.17 09:26:12
      Beitrag Nr. 13 ()
      Array BioPharma Announces Strategic Collaboration with Merck

      PR Newswire PR NewswireMay 8, 2017
      BOULDER, Colo., May 8, 2017 /PRNewswire/ -- Array BioPharma Inc. (ARRY) announced today that it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada) to investigate the safety and efficacy of Array's MEK inhibitor, binimetinib, with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors (MSS CRC).

      The companies are entering into this collaboration based on the growing body of preclinical and clinical evidence that the immune activity of an anti-PD-1 therapy, such as KEYTRUDA, can be enhanced when combined with a MEK inhibitor, such as binimetinib.

      "Array is excited to announce this partnership with Merck, an established leader in the field of immuno-oncology," said Ron Squarer, Chief Executive Officer, Array BioPharma. "Given the synergistic activity we have seen with our MEK inhibitor when combined with anti-PD-1 therapy in preclinical models, and based on emerging clinical data, we are optimistic that this combination holds great potential for cancer patients."

      Under the terms of the agreement, Array and Merck will collaborate on a clinical trial to investigate the safety and efficacy of the combination of binimetinib with KEYTRUDA, in MSS CRC patients. The trial is expected to establish a recommended dose regimen of binimetinib and KEYTRUDA, as well as explore the preliminary anti-tumor activity of several novel regimens. The study is expected to begin in the second half of 2017. Results from this first study will be used to determine optimal approaches to further clinical development of these combinations.

      The collaboration agreement is between Array BioPharma and Merck, through a subsidiary. Under the agreement, the trial will be sponsored by Merck. Additional details of the collaboration were not disclosed.

      https://finance.yahoo.com/news/array-biopharma-announces-str…
      Avatar
      schrieb am 10.05.17 10:09:56
      Beitrag Nr. 14 ()
      Array BioPharma Announces Positive Top-Line Results from Part 2 of the Phase 3 COLUMBUS Study of Binimetinib and Encorafenib for BRAF-Mutant Melanoma

      BOULDER, Colo., May 9, 2017 /PRNewswire/ -- Array BioPharma (ARRY) today announced top-line results from Part 2 of the Phase 3 COLUMBUS study evaluating binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The primary analysis of Part 2 compared progression free survival (PFS) in patients treated with binimetinib 45mg twice daily plus encorafenib 300mg daily (COMBO300) to patients treated with encorafenib 300mg daily as a single agent. The median PFS for patients treated with COMBO300 was 12.9 months compared to 9.2 months for patients treated with single agent encorafenib, with HR of 0.77 [95% CI 0.61-0.97, p=0.029]. COMBO300 was generally well-tolerated and reported dose intensity and adverse events were consistent with COMBO450 results in COLUMBUS Part 1. Part 2 was designed specifically to assess the contribution of binimetinib to the combination of binimetinib and encorafenib by reducing the dose of encorafenib to 300mg in the combination arm to allow for a comparison of equal doses across arms. Further results from Part 2 will be presented at a medical meeting during the second half of 2017.

      "The totality of the COLUMBUS results, including estimated progression free survival, objective response rate, dose intensity and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of binimetinib plus encorafenib as an attractive treatment option for patients diagnosed with BRAF-mutant melanoma," said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital and Professor of Medicine, Harvard Medical School.

      Ron Squarer, Chief Executive Officer at Array BioPharma noted: "The robust PFS benefit and tolerability observed with binimetinib plus encorafenib in COLUMBUS Part 2 once again demonstrates the combination represents a potentially important addition to the MEK/BRAF treatment landscape for patients with BRAF-mutant melanoma. The results of Part 2 confirm the contribution of binimetinib to the combination."

      Based on the strength of data from Part 1 and Part 2, Array is on track to file an NDA for COLUMBUS in June or July 2017.

      https://finance.yahoo.com/news/array-biopharma-announces-pos…
      Avatar
      schrieb am 10.05.17 14:25:36
      Beitrag Nr. 15 ()
      Array BioPharma reports 3Q loss

      Associated PressnMay 10, 2017
      BOULDER, Colo. (AP) _ Array BioPharma Inc. (ARRY) on Wednesday reported a loss of $35.3 million in its fiscal third quarter.

      The Boulder, Colorado-based company said it had a loss of 21 cents per share.

      The results did not meet Wall Street expectations. The average estimate of eight analysts surveyed by Zacks Investment Research was for a loss of 16 cents per share.

      The drug developer posted revenue of $33.3 million in the period, also falling short of Street forecasts. Four analysts surveyed by Zacks expected $47 million.

      Array BioPharma shares have decreased 20 percent since the beginning of the year. The stock has more than doubled in the last 12 months.

      https://finance.yahoo.com/news/array-biopharma-reports-3q-lo…
      Avatar
      schrieb am 30.05.17 14:25:44
      Beitrag Nr. 16 ()
      Array BioPharma and Bristol-Myers Squibb Announce Strategic Collaboration

      PR Newswire May 30, 2017
      BOULDER, Colo. and NEW YORK, May 30, 2017 /PRNewswire/ -- Array BioPharma (ARRY) and Bristol-Myers Squibb Company (BMY) today announced the companies have entered into a clinical research collaboration to investigate the safety, tolerability and efficacy of Array's investigational MEK inhibitor, binimetinib in combination with Bristol-Myers Squibb's Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a potential treatment for metastatic colorectal cancer in patients with microsatellite stable tumors.

      "Array is pleased to announce this new collaboration with Bristol-Myers Squibb," said Ron Squarer, CEO Array BioPharma. "Based on emerging data, we believe that studying combinations of targeted therapies, such as binimetinib, with immuno-oncology agents, such as Opdivo and Yervoy, could provide important scientific advances for patients fighting cancer."


      "Colorectal cancer remains a challenging tumor where immunotherapy benefits have been limited to a subset of patients," said Fouad Namouni, senior vice president, head of Oncology Development, Bristol-Myers Squibb. "We are committed to investigating a wide range of oncology therapies, and look forward to studying the combination of Array's MEK inhibitor and our immunotherapies with the goal of developing more treatment options for patients."

      The Phase 1/2 study is expected to establish recommended dose regimens for further study and explore the preliminary anti-tumor activity of combining binimetinib with Opdivo, as well as binimetinib in combination with the Opdivo + Yervoy regimen.

      Results from this first study, which is anticipated to begin in the second half of 2017, will be used to determine optimal approaches to further clinical development of these combinations.

      Under the terms of the agreement, Array and Bristol-Myers Squibb will jointly support the study with Array acting as the sponsor.

      https://finance.yahoo.com/news/array-biopharma-bristol-myers…
      Avatar
      schrieb am 31.05.17 14:43:12
      Beitrag Nr. 17 ()
      Array BioPharma And Ono Pharmaceutical Co., Ltd. Announce A License, Development And Commercialization Partnership For Two Novel Oncology Compounds, Binimetinib And Encorafenib

      BOULDER, Colo. and OSAKA, Japan, May 31, 2017 /PRNewswire/ -- Array BioPharma Inc. (ARRY) and Ono Pharmaceutical Co., Ltd. ("Ono") today announced a license, development and commercialization partnership for Array's late-stage novel oncology compounds, binimetinib and encorafenib.
      As a result of this agreement, Ono will receive rights to develop and commercialize binimetinib and encorafenib in Japan and South Korea. Binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, are currently in two global Phase 3 trials, for the treatment of patients with BRAF-mutant melanoma (COLUMBUS) and BRAF-mutant colorectal cancer (BEACON CRC).

      Under the terms of the agreement, Array will receive an upfront payment of $31.6 million (¥3.5 billion) and retains exclusive commercialization rights for binimetinib and encorafenib in the United States, Canada and Israel. Array is entitled to receive up to an additional $156 million (¥17.3 billion) if certain development and commercial milestones are achieved.
      A portion of these milestones is related to the Phase 3 BEACON CRC trial. In addition, Array will be eligible for robust, tiered, double-digit royalties based on product sales in Japan and South Korea. Ono will obtain the right to conduct clinical trials of binimetinib and encorafenib in Japan and South Korea, as well as participate in all future global development of binimetinib and encorafenib by contributing 12% of those future costs.

      "In Ono, we selected a market leader in immuno-oncology with a rapidly growing product portfolio and recent track record of successful development and commercialization in Japan," said Ron Squarer, Chief Executive Officer, Array BioPharma. "This partnership allows us to remain focused on commercializing binimetinib and encorafenib in the US, while benefiting from Ono's clear expertise in these key markets."

      "We are very delighted to collaborate on binimetinib and encorafenib with Array, a leading company with proven and successful experience in research and development of molecularly targeted therapy," said Gyo Sagara, President, Representative Director and Chief Executive Officer, Ono. "These two compounds have shown promising efficacy and safety in the previous clinical trials and we believe that both compounds can be a new therapeutic option as a combination therapy for patients with BRAF-mutant melanoma, BRAF-mutant colorectal cancer and beyond."

      Binimetinib and encorafenib are investigational medicines and are not currently approved in any country.

      https://finance.yahoo.com/news/array-biopharma-ono-pharmaceu…
      1 Antwort
      Avatar
      schrieb am 01.06.17 07:59:02
      Beitrag Nr. 18 ()
      Antwort auf Beitrag Nr.: 55.050.250 von bernie55 am 31.05.17 14:43:12Dieser Deal hat sehr gute Auswirkungen, vor allem werden die Cash-Reserven gestärkt und zukünftige Entwicklungsausgaben reduziert --> "as well as participate in all future global development of binimetinib and encorafenib by contributing 12% of those future costs."

      Die Kombi zur Behandlung von BRAF V600 mut.-positiv fortgeschrittem Melanom wird wohl 2018 auf den Markt kommen und in Konkurrenz stehen zu COTELLIC® (cobimetinib) + ZELBORAF® (vemurafenib) und TAFINLAR® (dabrafenib) + MEKINIST® (trametinib)
      Avatar
      schrieb am 02.06.17 12:44:06
      Beitrag Nr. 19 ()
      Array Biopharma To Present At The Goldman Sachs 38th Annual Global Healthcare Conference

      PR Newswire 2017
      BOULDER, Colo., June 1, 2017 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced that its Chief Operating Officer, Andy Robbins, will present at the Goldman Sachs 38th Annual Global Healthcare Conference. The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

      Event:
      Goldman Sachs 38th Annual Global Healthcare Conference
      Presenter:
      Andy Robbins, Chief Operating Officer
      Date:
      Tuesday, June 13, 2017
      Time:
      10:00 a.m. Pacific Time

      Webcast:
      https://cc.talkpoint.com/gold006/061317a_as/?entity=52_O16UK…
      3 Antworten
      Avatar
      schrieb am 29.06.17 20:00:53
      Beitrag Nr. 20 ()
      Antwort auf Beitrag Nr.: 55.066.630 von bernie55 am 02.06.17 12:44:06auch wenn bei der Auslizenzierung von Larotrectinib wohl eine "Perle" abgegeben wurde, wird der potenzielle Erfolg an ARRY nicht spurlos vorbeigehen:
      bin wieder in ARRY eingestiegen - als mittel- bis langfristiges Investment!



      Loxo Oncology hinsichtlich Larotrectinib:

      With respect to product candidates directed to TRK, including larotrectinib and its back-up compounds, the Company could be required to pay Array up to $223 million in milestone payments for each compound, the substantial majority of which are due upon the achievement of commercial


      The Company is required to pay Array mid-single digit royalties on worldwide net sales of products. With respect to the royalty on products directed
      2 Antworten
      Avatar
      schrieb am 05.07.17 16:53:04
      Beitrag Nr. 21 ()
      Antwort auf Beitrag Nr.: 55.232.768 von Cyberhexe am 29.06.17 20:00:53
      Zitat von Cyberhexe: auch wenn bei der Auslizenzierung von Larotrectinib wohl eine "Perle" abgegeben wurde, wird der potenzielle Erfolg an ARRY nicht spurlos vorbeigehen:

      bin wieder in ARRY eingestiegen - als mittel- bis langfristiges Investment!


      ......dann würde ich mal sagen: " Auf zu neuen Höhen" ;) :)
      1 Antwort
      Avatar
      schrieb am 05.07.17 17:15:24
      Beitrag Nr. 22 ()
      Antwort auf Beitrag Nr.: 55.268.485 von bernie55 am 05.07.17 16:53:04Cobi und Vemurafenib erhalten weitere Konkurrenz:

      BOULDER, Colo., July 5, 2017 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) today announced the submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The submissions are supported by data from the pivotal Phase 3 COLUMBUS study, which showed that patients who received binimetinib and encorafenib had a significantly longer progression free survival (PFS) compared to patients receiving vemurafenib.
      Avatar
      schrieb am 19.07.17 10:24:02
      Beitrag Nr. 23 ()
      :) Amgen And Array BioPharma Announce Preclinical License And Collaboration Agreement In Inflammation :)


      Array to Advance Preclinical Program for Autoimmune Disorders

      Amgen Responsible for Clinical Development and Worldwide Commercialization


      THOUSAND OAKS, Calif. and BOULDER, Colo., July 18, 2017 /PRNewswire/ -- Amgen (AMGN) and Array BioPharma (ARRY) today announced a collaboration agreement for the discovery and development of novel drugs for autoimmune disorders. The undisclosed target and lead inhibitors were discovered through Array's proprietary platform that leverages Array's expertise in chemistry and early lead development.

      "We are pleased to enter this collaboration with Array that builds on our continued focus in inflammation, one of Amgen's key strategic areas of interest," said Flavius Martin, M.D., vice president of Research, Inflammation and Oncology at Amgen. "We look forward to partnering with Array BioPharma to advance molecules into the clinic that may offer a new treatment option for patients."

      "We look forward to collaborating with Amgen, a leader in treatments for inflammatory disease, on this exciting target which was discovered using Array's proprietary Kinase-Directed Phenotypic Screening Platform," said Nicholas A. Saccomano, Ph.D., chief scientific officer at Array BioPharma. "The identification of this novel target, along with our team's deep experience in kinase inhibitor chemistry, gives us confidence that our efforts will result in a drug which will address a significant unmet medical need for patients with inflammatory disease."

      Under the terms of the agreement, Amgen and Array will collaborate on preclinical development with Array leading the medicinal chemistry work. Amgen is responsible for clinical development and commercialization. In exchange for exclusive rights to Array's preclinical program, Amgen will make upfront and milestone payments, as well as pay royalties on sales of resulting therapies.

      https://finance.yahoo.com/news/amgen-array-biopharma-announc…
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      schrieb am 30.08.17 15:32:08
      Beitrag Nr. 24 ()
      Array Biopharma To Present BEACON CRC Safety Lead-in And COLUMBUS Part 2 Results At European Society For Medical Oncology Congress (ESMO)

      PR Newswire PR NewswireAugust 30, 2017Comment
      - Array to host investor reception and webcast during ESMO on September 9 -

      BOULDER, Colo., Aug. 30, 2017 /PRNewswire/ -- Array BioPharma Inc. (ARRY), a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule cancer therapies, announced today that results from the Phase 3 BEACON CRC safety lead-in study in BRAF-mutant colorectal cancer and the Phase 3 COLUMBUS Part 2 study in BRAF-mutant melanoma will be presented at the 2017 European Society for Medical Oncology Congress in Madrid, Spain on September 9. In addition, Array will host an investor reception and webcast on September 9.

      BEACON CRC SAFETY LEAD-IN DATA
      A presentation of data from the safety lead-in will take place on Saturday, September 9 from 1:15 – 2:15 pm CEST (7:15 – 8:15 am EDT). The presentation will include details on the safety and tolerability profile of the triplet therapy, encorafenib + binimetinib + cetuximab, as well as preliminary measures of efficacy including overall response rate and available durability results.

      Abstract #517P: BEACON CRC: Safety Lead-In (SLI) for the Combination of Binimetinib (BINI), Encorafenib (ENCO), and Cetuximab (CTX) in Patients (Pts) with BRAFV600E Metastatic Colorectal Cancer (mCRC)
      COLUMBUS PART 2 TRIAL DATA

      Data from Part 2 of the Phase 3 study will be featured as an oral presentation on Saturday, September 9 at 2:45 pm Central European Summer Time (CEST) (8:45 am EDT). The presentation will include progression free survival, objective response rate, dose intensity, safety and tolerability.

      Abstract #1215O: Results of COLUMBUS Part 2: A Phase 3 Trial of Encorafenib (ENCO) Plus Binimetinib (BINI) Versus ENCO in BRAF-Mutant Melanoma

      ARRAY INVESTOR RECEPTION AND WEBCAST: Array will host an investor reception during ESMO 2017 where key opinion leaders in the colorectal cancer field, including Dr. Scott Kopetz, M.D. Anderson and Dr. Axel Grothey, Mayo Clinic will give presentations covering the BRAF-mutant colorectal cancer landscape and data from the BEACON CRC safety lead-in. The presentations will be webcast (live and replay), for those who wish to participate remotely.

      https://finance.yahoo.com/news/array-biopharma-present-beaco…
      1 Antwort
      Avatar
      schrieb am 11.09.17 14:06:55
      Beitrag Nr. 25 ()
      Antwort auf Beitrag Nr.: 55.629.281 von bernie55 am 30.08.17 15:32:08Phase 3 COLUMBUS Part 2 Results in BRAF-Mutant Melanoma Presented at European Society for Medical Oncology Congress

      PR Newswire September 9, 2017

      - Median PFS for patients on combination of binimetinib (45 mg) plus encorafenib (300 mg) was 12.9 months versus 9.2 months for patients on encorafenib (300 mg) -

      - Generally well-tolerated and safety profile consistent with COLUMBUS Part 1 results -

      - New Drug Applications (NDAs) were submitted to the FDA and Marketing Authorization Applications (MAAs) are under review with the EMA for binimetinib and encorafenib in BRAF-mutant advanced melanoma -

      https://finance.yahoo.com/news/phase-3-columbus-part-2-13300…
      Avatar
      schrieb am 14.09.17 11:17:52
      Beitrag Nr. 26 ()
      Array BioPharma Announces FDA Acceptance For Review Of Binimetinib And Encorafenib New Drug Applications For Patients With Advanced BRAF-mutant Melanoma


      PR Newswire September 12, 2017
      BOULDER, Colo., Sept. 12, 2017 /PRNewswire/ -- Array BioPharma (ARRY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Applications (NDAs) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The FDA set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2018 for both applications. In addition, the FDA informed Array that based on their preliminary review of the applications they have not identified any potential review issues, and that they are not currently planning to hold an advisory committee meeting to discuss these NDAs. Array completed its NDA submissions at the end of June 2017 based on findings from the pivotal Phase 3 COLUMBUS trial.


      "We look forward to working with the FDA and EMA as they review our New Drug Applications for binimetinib and encorafenib," said Ron Squarer, Chief Executive Officer. "The robust PFS benefit together with the attractive tolerability profile demonstrated in COLUMBUS suggest the combination represents a potentially important addition to the MEK/BRAF treatment landscape for patients with BRAF-mutant melanoma."

      https://finance.yahoo.com/news/array-biopharma-announces-fda…
      Avatar
      schrieb am 14.09.17 11:21:49
      Beitrag Nr. 27 ()
      Array BioPharma shares slide on secondary offering announcement

      Sept 13, 2017 5:13 p.m. ET
      By
      WALLACE
      WITKOWSKI


      Array BioPharma Inc. shares fell in the extended session Wednesday after the drug developer announced a secondary offering of its shares. Array shares fell 7.9% to $9.70 after hours. The company said it plans to offer $175 million in shares, with an additional $26.3 million to cover overallotments. Based on Wednesday's closing price of $10.53, the offering including overallotments would represent about 19.1 million shares. Array has 171.4 million shares outstanding.

      J.P. Morgan Securities, Cowen & Co., and Piper Jaffray are listed among the bookrunners for the offering.

      http://www.marketwatch.com/story/array-biopharma-shares-slid…
      Avatar
      schrieb am 15.09.17 13:27:45
      Beitrag Nr. 28 ()
      BioPharma Inc. (ARRY): Stock Offering News

      ARRY – Prices offering of 20,930,232 shares of its common stock at of $10.75 per share.

      SEP 15, 2017 | 6:16AM | BY STOCKNEWS.COM STAFF

      https://stocknews.com/news/arry-prices-offering-of-20930232-…
      1 Antwort
      Avatar
      schrieb am 19.09.17 15:26:21
      Beitrag Nr. 29 ()
      Antwort auf Beitrag Nr.: 55.751.754 von bernie55 am 15.09.17 13:27:45Array BioPharma Announces Closing of Public Offering and Full Exercise of Option to Purchase Additional Shares

      https://finance.yahoo.com/news/array-biopharma-announces-clo…
      Avatar
      schrieb am 21.09.17 14:04:10
      Beitrag Nr. 30 ()
      Array BioPharma To Present At The 2017 Cantor Fitzgerald Global Healthcare Conference


      BOULDER, Colo., Sept. 19, 2017 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced that its Chief Executive Officer, Ron Squarer, will present at the 2017 Cantor Fitzgerald Global Healthcare Conference. The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

      Event:
      Cantor Fitzgerald Global Healthcare Conference

      Presenter:
      Ron Squarer, Chief Executive Officer

      Date:
      Tuesday, September 26, 2017

      Time:
      8:35 a.m. Eastern Time

      Webcast:
      http://wsw.com/webcast/cantor6/arry/


      https://finance.yahoo.com/news/array-biopharma-present-2017-…
      Avatar
      schrieb am 29.09.17 14:16:54
      Beitrag Nr. 31 ()
      Nachbörslich waren gestern enorme Umsätze zu verzeichnen.
      Irgendwas im Busch ??


      16:21 - $ 12.25 > 319,200 :eek:
      16:21 - $ 12.25 > 191,600 :eek:
      16:20 - $ 12.25 > 638,400 :eek:


      Avatar
      schrieb am 19.12.17 15:20:36
      Beitrag Nr. 32 ()
      Array BioPharma Announces Strategic Collaboration with Pfizer


      PR Newswire December 19, 2017
      Novel combinations of binimetinib (MEK), avelumab (PD-L1), and talazoparib (PARP inhibitor) to be studied across tumor types

      BOULDER, Colo., Dec. 19, 2017 /PRNewswire/ -- Array BioPharma (ARRY) announced today that it has entered into a clinical trial collaboration agreement with Pfizer to investigate the safety and efficacy of several novel anti-cancer combinations, including Array's MEK inhibitor, binimetinib, with Pfizer's investigational PARP inhibitor talazoparib, and avelumab*, a human anti-PD-L1 IgG1 monoclonal antibody.

      The companies are entering into this collaboration to explore the potential benefits of combining molecularly targeted therapeutics with the body's innate cancer-fighting abilities using immunotherapy.

      "Array is excited to announce this partnership with Pfizer, an established global leader in Oncology therapeutics," said Ron Squarer, Chief Executive Officer, Array BioPharma. "These novel approaches combining targeted therapy and immunotherapy hold great potential to help patients fighting cancer in different indications, with an initial main focus on lung and pancreatic cancer."

      "Preclinical data indicate that combining binimetinib with an immune checkpoint inhibitor and talazoparib could be a rational combination to test in the clinic," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "We are looking forward to initiating the clinical studies with Array BioPharma to explore anti-tumor activity across various novel combination strategies, including both doublet and triplet approaches."

      Under the terms of the agreement, Array and Pfizer will collaborate on a Phase 1b clinical trial to explore a series of novel combinations, investigating the safety and efficacy of the combination of binimetinib, avelumab and talazoparib across various tumor types. A multi-arm clinical trial is expected to establish recommended doses of different regimens combining the drugs. Initially the focus will be in non-small cell lung cancer (NSCLC) and pancreatic cancer, and additional indications will be explored at a later stage. The study is expected to begin by the third quarter of 2018, and results will be used to determine optimal approaches to further clinical development of these combinations.

      Under the collaboration agreement, the trial will be sponsored and funded by Pfizer, with Array providing binimetinib supply.

      *Avelumab is jointly developed by Merck KGaA, Darmstadt, Germany and Pfizer. Avelumab is under clinical investigation for treatment of NSCLC and pancreatic cancer and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for these indications by any health authority worldwide.

      https://finance.yahoo.com/news/array-biopharma-announces-str…
      Avatar
      schrieb am 03.01.18 13:22:30
      Beitrag Nr. 33 ()
      Array BioPharma To Present At The Annual J.P. Morgan Healthcare Conference

      PR Newswire•January 2, 2018

      BOULDER, Colo., Jan. 2, 2018 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced that its Chief Executive Officer, Ron Squarer, will speak at the Annual J.P. Morgan Healthcare Conference in San Francisco. The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

      Event:
      Annual J.P. Morgan Healthcare Conference

      Presenter:
      Ron Squarer, Chief Executive Officer, Array BioPharma

      Date:
      Monday, January 8, 2018

      Time:
      4:00 p.m. Pacific Time

      Location:
      Westin St. Francis Hotel, San Francisco

      Webcast:

      http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=…
      Avatar
      schrieb am 03.01.18 13:25:58
      Beitrag Nr. 34 ()
      ASLAN Pharmaceuticals Acquires Full Global Commercial Rights for Varlitinib From Array BioPharma

      SINGAPORE, Jan. 03, 2018 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (ASLAN, 6497.TT), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, today announced that Array BioPharma Inc (Array) has granted ASLAN full global rights to develop, manufacture and commercialise varlitinib. The new licensing agreement replaces the prior licensing agreement signed in 2011 to develop and sublicense varlitinib, which did not grant commercial rights to ASLAN.

      Dr Carl Firth, Chief Executive Officer of ASLAN Pharmaceuticals, said: “Acquiring full global commercial rights to varlitinib is a significant positive move for ASLAN. Varlitinib has demonstrated strong efficacy in the studies that we have conducted since signing the original licensing agreement with Array, in biliary tract, gastric, breast and colorectal cancer. Based on this data, we want to take the drug to market and commercialise it ourselves in certain geographies, which was not contemplated under the original agreement. The new agreement allows us to retain much more downstream value from our own commercial and future partnering activities.”

      Under the terms of the original agreement signed on 12 July 2011, ASLAN was responsible for the development of varlitinib through to proof-of-concept and the identification of a partner to complete phase 3 development and commercialisation. Array was eligible to receive 50% of all varlitinib revenues, including proceeds from outlicensing agreements.

      The terms of the new agreement grant ASLAN exclusive global rights to commercialise and sublicense varlitinib. ASLAN will make an upfront payment of US$12 million to Array on signature and a further payment of up to US$12 million within the next twelve months, together with up to US$30 million of development and US$75 million of commercial milestones, as well as tiered low double-digit royalties as a percentage of net sales of varlitinib.

      https://globenewswire.com/news-release/2018/01/03/1281369/0/…
      Avatar
      schrieb am 16.01.18 15:35:03
      Beitrag Nr. 35 ()
      Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant Colorectal Cancer at the 2018 Gastrointestinal Cancers Symposium
      PR Newswire • January 16, 2018


      - January 16: Abstract contains previously presented safety and clinical activity data, as well as new data on tumor markers -

      - January 20: Presentation to include updated overall response rate (ORR), duration of response and safety, as well as new data on median progression free survival (mPFS)
      https://finance.yahoo.com/news/array-biopharma-present-updat…" target="_blank" rel="nofollow ugc noopener">
      https://finance.yahoo.com/news/array-biopharma-present-updat…
      9 Antworten
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      schrieb am 22.01.18 09:00:18
      Beitrag Nr. 36 ()
      Antwort auf Beitrag Nr.: 56.730.996 von bernie55 am 16.01.18 15:35:03Combination of Encorafenib, Binimetinib and Cetuximab Demonstrated an 8 Month Median Progression-Free Survival in BRAF-Mutant Colorectal Cancer in Updated Safety Lead-In Results from BEACON Phase 3 Trial

      -- Median PFS of 8.0 months at time of analysis --

      -- 48% confirmed ORR, including 3 complete responses --


      -- Data presented at the ASCO 2018 Gastrointestinal Cancers Symposium --

      Jan 20, 2018, 10:05 ET from Array BioPharma Inc.

      BOULDER, Colo. and CASTRES, France, Jan. 20, 2018 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) and Pierre Fabre today announced updated results from the 30 patient safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF-mutant metastatic colorectal cancer (CRC) whose disease has progressed after one or two prior regimens. The data were presented at the ASCO 2018 Gastrointestinal Cancers Symposium in San Francisco, California.

      In patients with the BRAFV600E mutation, the estimated median progression-free survival (mPFS) at the time of analysis was 8 months. The confirmed overall response rate (ORR)* in patients with the BRAFV600E mutation was 48%, and 3 patients achieved complete responses (CR). Further, the ORR was 62% in the 16 patients (10/16) who received only one prior line of therapy. These data represent substantial improvements compared to several separate historical published standard of care benchmarks for this population.

      "We are very excited about these safety lead-in results, which show both an unprecedented progression-free survival and overall response rate in patients with BRAFV600-mutant colorectal cancer," said Scott Kopetz, M.D., Ph.D., FACP, Associate Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. "To put these data in context, the observed median progression-free survival of 8 months exceeds historical benchmarks of approximately 2 months for median progression-free survival, and 4 to 6 months for median overall survival, with current standards of care in this patient population. These results demonstrate the potential of the triplet combination to benefit this population of patients who currently have very limited effective treatment options."

      In the safety lead-in, the triplet combination was generally well-tolerated. Two patients discontinued treatment due to adverse events (AEs) with only one of these considered related to treatment. The most common grade 3 or 4 AEs seen in at least 10% of patients were fatigue (4/30), urinary tract infection (3/30), increased aspartate aminotransferase (AST; 3/30) and increased blood creatine kinase (CK; 3/30).

      All patients with elevated baseline levels of the tumor markers CEA and CA19-9 had a reduction from baseline, with similar and substantial (median 83% - 96%) reductions across both markers in patients with objective responses and those with stable disease.

      The enrollment in the randomized portion of the BEACON CRC trial is ongoing. Patients interested in participating in this trial may talk to their doctor to have their tumor tested for the BRAF mutation for eligibility to enroll in this new and important trial. Further details on the trial are available at clinicaltrials.gov (NCT02928224).

      A PDF of the ASCO 2018 Gastrointestinal Cancers Symposium presentation can be found on Array's website: http://www.arraybiopharma.com/download_file/282/

      *Overall response rate (ORR) = Complete response (CR) + Partial response (PR)

      https://www.prnewswire.com/news-releases/combination-of-enco…
      8 Antworten
      Avatar
      schrieb am 22.01.18 09:39:27
      Beitrag Nr. 37 ()
      Bernie55....kannst Du mir verraten, warum Du Daten, die im anderen Thread längst eingestellt sind hier doppelt postest??
      Es wäre doch viel hilfreicher, in einem Thread zu posten, oder??
      1 Antwort
      Avatar
      schrieb am 22.01.18 10:20:04
      Beitrag Nr. 38 ()
      Antwort auf Beitrag Nr.: 56.785.981 von evotecci am 22.01.18 09:39:27
      Zitat von evotecci: Bernie55....kannst Du mir verraten, warum Du Daten, die im anderen Thread längst eingestellt sind hier doppelt postest??
      Es wäre doch viel hilfreicher, in einem Thread zu posten, oder??


      Hallo evotechi,
      es gibt eine einfache Erklärung dafür, warum ich die Daten in diesen Thread reingepostet habe.

      Ich habe bisher nicht gewusst, dass es einen anderen ARRAY Thread gibt.

      Schön , dass du mich darauf aufmerksam gemacht hast ...
      ....und vielleicht hättest du mir die Info einfach schön früher geben können. ;)
      Avatar
      schrieb am 22.01.18 13:25:02
      Beitrag Nr. 39 ()
      Antwort auf Beitrag Nr.: 56.785.585 von bernie55 am 22.01.18 09:00:18....die ersten Updates bzgl. Kursziele lassen auch nicht lange auf sich warten....




      ...und noch ein Update.....


      5 Antworten
      Avatar
      schrieb am 22.01.18 14:28:19
      Beitrag Nr. 40 ()
      Antwort auf Beitrag Nr.: 56.788.336 von bernie55 am 22.01.18 13:25:02.................vielleicht klappt es ja heute nach der tollen News mit einem Kurs über 14 USD...............

      4 Antworten
      Avatar
      schrieb am 22.01.18 23:42:42
      Beitrag Nr. 41 ()
      Antwort auf Beitrag Nr.: 56.789.002 von bernie55 am 22.01.18 14:28:19neben der sehr erfreulichen Nachricht von Samstag bei Darmkrebs....


      Combination of Encorafenib, Binimetinib and Cetuximab Demonstrated an 8 Month Median Progression-Free Survival in BRAF-Mutant Colorectal Cancer in Updated Safety Lead-In Results from BEACON Phase 3 Trial
      -- Median PFS of 8.0 months at time of analysis --
      -- 48% confirmed ORR, including 3 complete responses --
      -- Data presented at the ASCO 2018 Gastrointestinal Cancers Symposium --
      BOULDER, Colo. and CASTRES, France, Jan. 20, 2018 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) and Pierre Fabre today announced updated results from the 30 patient safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF-mutant metastatic colorectal cancer (CRC) whose disease has progressed after one or two prior regimens. The data were presented at the ASCO 2018 Gastrointestinal Cancers Symposium in San Francisco, California.

      http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=…



      ...gibt es auf der heute vom europ. Arzneimittelausschuss CHMP veröffentlichten Agenda zur Januarsitzung einen kleinen Wermutstropfen,und zwar wurde der Antrag von Binimetinib zur Behandlung von Melanoma

      3 Antworten
      Avatar
      schrieb am 23.01.18 08:18:27
      Beitrag Nr. 42 ()
      Antwort auf Beitrag Nr.: 56.795.092 von Cyberhexe am 22.01.18 23:42:42Nanu? Das ist aktuell? Ich dachte NRAS hätte sich eh erledigt gehabt. In den USA ist das bestimmt 1 Jahr her, dass man den Zulassungsantrag zurückgezogen hat. Die Ergebnisse waren aber auch ziemlich mau...
      2 Antworten
      Avatar
      schrieb am 23.01.18 08:47:47
      Beitrag Nr. 43 ()
      Antwort auf Beitrag Nr.: 56.796.172 von kmastra am 23.01.18 08:18:27
      Zitat von kmastra: Nanu? Das ist aktuell? Ich dachte NRAS hätte sich eh erledigt gehabt. In den USA ist das bestimmt 1 Jahr her, dass man den Zulassungsantrag zurückgezogen hat. Die Ergebnisse waren aber auch ziemlich mau...



      ....das ist aktuell --> Agenda des CHMP für die Januarsitzung von Mo, 22.1.2018 bis Do, 25.1.2018

      http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_e…
      1 Antwort
      Avatar
      schrieb am 23.01.18 12:49:15
      Beitrag Nr. 44 ()
      Antwort auf Beitrag Nr.: 56.785.585 von bernie55 am 22.01.18 09:00:18Kommentar, Einschätzung und möglicher Ausblick bzgl. der vorliegenden Ergebnisse des Phase 3 -BEACON CRC trial


      Why Array BioPharma Inc. Is Soaring
      Motley Fool
      Brian Feroldi, The Motley Fool

      January 22, 2018


      Dr. Scorr Kopetz, a physician at the University of Texas MD Anderson Cancer Center, helped put this data into context:

      The observed median progression-free survival of eight months exceeds historical benchmarks of approximately two months for median progression-free survival, and four to six months for median overall survival, with current standards of care in this patient population. These results demonstrate the potential of the triplet combination to benefit this population of patients who currently have very limited effective treatment options.

      Now what
      2018 is poised to be a transformative year for Array. Both binimetinib and encorafenib are currently pending regulatory review in the U.S. and Europe as a treatment for BRAF-mutant metastatic melanoma. A PDUFA date of June 30, 2018 has been set, so it won't be long before shareholders have a go/no-go decision in hand.

      What are the odds of success?
      That's tough to say, but my hunch is that the company's chances are favorable since the COLUMBUS study showed that using these drugs lead to enhanced progression-free survival rates when compared to Roche's current top-selling treatment Zelboraf. Adding in this recent data from the BEACON CRC trial should give investors increased confidence that these drugs are the real deal.

      All in all, Array's shareholders have plenty of reason to remain excited about binimetinib and encorafenib, not to mention the rest of the company's pipeline.


      However, there's an argument to be made that Array's current market cap of $3 billion is already pricing in the green light from regulators. That's why this Fool plans to root for Array's success from the sidelines.


      https://finance.yahoo.com/news/why-array-biopharma-inc-soari…
      1 Antwort
      Avatar
      schrieb am 23.01.18 15:42:58
      Beitrag Nr. 45 ()
      Antwort auf Beitrag Nr.: 56.799.769 von bernie55 am 23.01.18 12:49:15Viele Übernahmen in letzter Zeit.......

      Gilead to aquire Kite Pharma for $11.9B.

      Celgene to acquire Juno Therapeutics for $9B

      Sanofi to acquire Bioverativ for $11.6 Billion



      . . . vielleicht ? ;)
      . . . bald ? ;)


      ?. . . . . to aquire Array BioPharma Inc. for . . . ?
      Avatar
      schrieb am 23.01.18 21:13:58
      Beitrag Nr. 46 ()
      Antwort auf Beitrag Nr.: 56.796.538 von Cyberhexe am 23.01.18 08:47:47Ach ja, für Europa ist je auch Pierre Faber zuständig. Hab nochmal nachgeschaut. ARRY hatte im März/17 den Zulassungsantrag in den USA widerrufen:

      http://www.onclive.com/web-exclusives/binimetinib-nrasmutant…

      The application for binimetinib was based on data from the phase III NEMO study, which was presented at the 2016 ASCO Annual Meeting. In the open-label study, median progression-free survival (PFS) with binimetinib was 2.8 versus 1.5 months with dacarbazine, representing a 38% reduction in the risk of progression or death (HR, 0.62; 95% CI, 0.47-0.80; P <.0001); however, overall survival (OS) was not improved with the MEK inhibitor.
      Avatar
      schrieb am 30.01.18 15:37:07
      Beitrag Nr. 47 ()
      Array BioPharma To Report Financial Results For The Second Quarter Of Fiscal 2018 On February 6, 2018

      PR Newswire

      BOULDER, Colo., Jan. 30, 2018 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) will report financial results for the second quarter of fiscal 2018 and hold a conference call to discuss those results on Tuesday, February 6, 2018. Ron Squarer, Chief Executive Officer, will lead the call.

      Date:

      Tuesday, February 6, 2018

      Time:

      9:00 a.m. Eastern Time



      Toll-Free:
      (844) 464-3927
      Toll:
      (765) 507-2598
      Pass Code:
      6187887

      https://finance.yahoo.com/news/array-biopharma-report-financ…" target="_blank" rel="nofollow ugc noopener">
      https://finance.yahoo.com/news/array-biopharma-report-financ…
      2 Antworten
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      schrieb am 01.02.18 12:06:06
      Beitrag Nr. 48 ()
      Antwort auf Beitrag Nr.: 56.874.911 von bernie55 am 30.01.18 15:37:07Was ist von den Financial Results For The Second Quarter Of Fiscal 2018 On February 6, 2018 zu erwarten ??



      Array BioPharma’s Financial Performance

      ,Market Realist•January 31, 2018




      https://marketrealist.com/2018/01/deeper-look-financial-perf…
      1 Antwort
      Avatar
      schrieb am 02.02.18 13:23:44
      Beitrag Nr. 49 ()
      ARRAY hat seit 2003 ein vertragliche Vereinbarung mit Astra Zeneca , die AstraZeneca erlaubt, Selumetinib in der Forschung zu verwenden. Im Juli 2017 hat Astra mit Merck eine neue Kooperationsvereinbarung vertraglich beschlossen, die eine $ 8.5 billion Zahlung mit einschließt. ARRAY fordert von Astra nun eine 12 prozentuale finanzielle " Abfindung" von dieser Gesamtsumme.

      Die Klage geht nun vor das Oberste Gericht des Staates New York.




      AstraZeneca is sued by Array BioPharma over cancer drug royalties


      Reuters•February 1, 2018

      NEW YORK (Reuters) - Array BioPharma Inc (ARRY.O) on Thursday sued AstraZeneca AB (AZN.L), accusing the pharmaceutical company of refusing to pay required royalties for a cancer drug after entering into an $8.5 billion (5.96 billion pounds) collaboration with Merck & Co (MRK.N).

      In a complaint filed in the New York State Supreme Court in Manhattan, Array is seeking at least $192 million from AstraZeneca for the alleged breach of a 2003 licensing agreement related to the drug, known as selumetinib.

      AstraZeneca did not immediately respond to a request for comment.

      According to the complaint, selumetinib is a compound discovered by Boulder, Colorado-based Array that inhibits activity of an enzyme involved in cell growth and metabolism.

      Array said the 2003 agreement allowed AstraZeneca to use selumetinib in research to fight cancer, and provided for a 12-percent royalty on sums that AstraZeneca might receive from sub-licensees such as Merck.

      But according to the complaint, AstraZeneca said it intends to pay that royalty on what Array called an "absurdly small" fraction of an expected $1.6 billion upfront payment from Merck. The $192 million sought represents 12 percent of that payment.

      Both companies agreed to have disputes under the agreement decided by New York courts, the complaint said.

      Array's revenue totalled $150.9 million in the year ended June 30, 2017, a regulatory filing shows.

      Last July, AstraZeneca agreed to collaborate with Merck to study cancer drug combinations using its drug Lynparza, which regulators have approved to treat ovarian cancer and which could have other uses when combined with immunotherapy.

      Merck agreed to pay AstraZeneca up to $8.5 billion in exchange for half of future Lynparza sales.

      AstraZeneca has said it plans to report full-year results on Friday.

      The case is Array BioPharma Inc v AstraZeneca AB, New York State Supreme Court, New York County, No. 650517/2018.
      https://finance.yahoo.com/news/astrazeneca-sued-array-biopha…" target="_blank" rel="nofollow ugc noopener">
      https://finance.yahoo.com/news/astrazeneca-sued-array-biopha…


      Avatar
      schrieb am 06.02.18 14:48:44
      Beitrag Nr. 50 ()
      Antwort auf Beitrag Nr.: 56.897.411 von bernie55 am 01.02.18 12:06:06
      Zitat von bernie55: Was ist von den Financial Results For The Second Quarter Of Fiscal 2018 On February 6, 2018 zu erwarten ??


      https://marketrealist.com/2018/01/deeper-look-financial-perf…



      Array BioPharma reports 2Q loss


      Associated Press•February 6, 2018

      BOULDER, Colo. (AP) _ Array BioPharma Inc. (ARRY) on Tuesday reported a loss of $34.1 million in its fiscal second quarter.

      The Boulder, Colorado-based company said it had a loss of 17 cents per share.

      The results exceeded Wall Street expectations. The average estimate of eight analysts surveyed by Zacks Investment Research was for a loss of 23 cents per share.

      The drug developer posted revenue of $42.2 million in the period, also exceeding Street forecasts. Five analysts surveyed by Zacks expected $24.8 million.


      Array BioPharma shares have risen 11 percent since the beginning of the year. The stock has climbed 32 percent in the last 12 months.
      https://finance.yahoo.com/news/array-biopharma-reports-2q-lo…" target="_blank" rel="nofollow ugc noopener">
      https://finance.yahoo.com/news/array-biopharma-reports-2q-lo…
      Avatar
      schrieb am 06.02.18 15:56:11
      Beitrag Nr. 51 ()
      Array melanoma drugs show significant survival vs Roche drug in study
      Reuters•February 6, 2018
      By Bill Berkrot

      Feb 6 (Reuters) - A combination of experimental drugs from Array BioPharma Inc kept patients with advanced melanoma associated with a common gene mutation alive for nearly three years :eek:and twice as long :eek:as a rival Roche Holding AG medicine, according to data from a late stage study released on Tuesday.

      The oral drugs, encorafenib and binimetinib, are awaiting a U.S. approval decision by June 30 based on promising data on their ability to stall disease worsening, or progression-free survival (PFS). European regulators are also reviewing the treatment.

      However, overall survival is seen as the gold standard for cancer treatments and the new data is likely to significantly enhance approval and eventual sales prospects.

      The Array combination - 450 milligrams of encorafenib once daily and 45 mg of binimetinib twice a day - led to median overall survival of 33.6 months in patients with advanced melanoma with a BRAF mutation, meaning half the patients were still alive nearly three years after treatment.

      That compared with median overall survival of 16.9 months for patients in the Phase III study who received Roche's Zelboraf, known chemically as vemurafenib.

      Advanced melanoma is the deadliest form of skin cancer. About half of the estimated 200,000 new melanoma cases diagnosed worldwide each year carry BRAF mutations.

      "There remains a substantial need for well-tolerated treatments that delay disease progression and improve overall survival,” Dr. Keith Flaherty, a lead investigator of the study from Massachusetts General Hospital Cancer Center in Boston, said in a statement.

      "This data suggests that the combination of encorafenib and binimetinib may have the potential to become a meaningful new therapy for patients with advanced BRAF-mutant melanoma," Flaherty added.

      In a pivotal trial of a similar already approved combination from Novartis, nearly 30 percent of patients were still alive five years after being treated with Tafinolar and Mekinist.

      PFS and safety data from the Array trial were previously announced.

      The Array medicines are being co-developed by privately-held French pharmaceuticals group Pierre Fabre.

      (Reporting by Bill Berkrot; Editing by Susan Thomas)

      https://finance.yahoo.com/news/array-melanoma-drugs-show-sig…
      1 Antwort
      Avatar
      schrieb am 06.02.18 16:02:46
      Beitrag Nr. 52 ()
      Antwort auf Beitrag Nr.: 56.950.436 von bernie55 am 06.02.18 15:56:11...und weil die News so Hammer ist......hier noch ein Link...

      Encorafenib and Binimetinib Combination Treatment Demonstrates 33.6 Month Median Overall Survival (OS) in Patients with BRAF-Mutant Melanoma in Phase 3 COLUMBUS Trial

      BOULDER, Colo. and CASTRES, France, Feb. 6, 2018 /PRNewswire/ -- Array BioPharma Inc. (ARRY) and Pierre Fabre today announced results of the planned analysis of overall survival (OS) from the pivotal Phase 3 COLUMBUS trial in patients with BRAF-mutant melanoma. Treatment with the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily (COMBO450) reduced the risk of death compared to treatment with vemurafenib 960 mg daily [hazard ratio (HR) of 0.61, [95% CI 0.47, 0.79, p <0.001]. Median OS was 33.6 months for patients treated with COMBO450, compared to 16.9 months for patients treated with vemurafenib as a monotherapy.


      More
      "Many patients with BRAF-mutant melanoma still face significant challenges managing their disease, and there remains a substantial need for well-tolerated treatments that delay disease progression and improve overall survival," said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School. "This data suggests that the combination of encorafenib and binimetinib may have the potential to become a meaningful new therapy for patients with advanced BRAF-mutant melanoma."

      At the time of the planned analysis comparing COMBO450 to vemurafenib monotherapy, a preliminary analysis of OS in patients treated with 300 mg encorafenib alone daily (ENCO300), demonstrated a median OS of 23.5 months.

      "We are excited to report these overall survival results from the COLUMBUS trial," said Victor Sandor, M.D., Chief Medical Officer, Array BioPharma. "This encouraging overall survival finding further validates previously reported median progression-free survival and overall response rate results, and taken together with the attractive tolerability profile, these data suggest that the combination of encorafenib with binimetinib has the potential to become a promising new treatment option for these patients."

      As previously reported, the combination of encorafenib and binimetinib was generally well-tolerated. Grade 3/4 adverse events (AEs) that occurred in more than 5% of patients receiving the combination were increased gamma-glutamyltransferase (GGT) (9%), increased blood creatine phosphokinase (CK) (7%) and hypertension (6%). The incidence of selected any grade AEs of special interest, defined based on toxicities commonly associated with commercially available BRAF+MEK-inhibitor treatments for patients receiving the combination of encorafenib and binimetinib included: rash (23%), pyrexia (18%), retinal pigment epithelial detachment (13%) and photosensitivity (5%). Full safety results of COLUMBUS Part 1 were presented at the 2016 Society for Melanoma Research Annual Congress.

      The U.S. Food and Drug Administration (FDA) is currently reviewing the New Drug Applications to support use of the combination of encorafenib and binimetinib for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The FDA set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2018 for both applications. In addition, the European Medicines Agency (EMA), as well as the Swiss Medicines Agency (Swissmedic) and the Australian Therapeutic Goods Administration (TGA), is reviewing the Marketing Authorization Applications for encorafenib and binimetinib.
      https://finance.yahoo.com/news/encorafenib-binimetinib-combi…" target="_blank" rel="nofollow ugc noopener">
      https://finance.yahoo.com/news/encorafenib-binimetinib-combi…
      Avatar
      schrieb am 07.02.18 10:51:13
      Beitrag Nr. 53 ()
      Die Daten aus dem COLUMBUS-Trial zeigen, dass bei der Kombi von Encorafenib and Binimetinib eine overall survival time von 33,6 Monaten erreicht wurde, somit sich die overall survival time gegenüber Patienten, die mit Zelboraf ( Firma ROCHE) behandelt wurden, nahezu verdoppelt hat. ( overall survival time 16,9 Monate )


      Wäre es denn jetzt nicht ein geschickter Schachzug seitens ROCHE, sich die Pipeline von ARRAY einzuverleiben, um einen möglichen Direktkonkurrenten in der Behandlung von BRAF-mutant melanoma effektiv "auszuschalten" ?
      Avatar
      schrieb am 07.02.18 12:50:49
      Beitrag Nr. 54 ()
      Wenn Du im anderen Thread schreiben würdest, müsstest Du nicht immer Selbstgespräche führen......,-))))
      20 Antworten
      Avatar
      schrieb am 07.02.18 13:28:11
      Beitrag Nr. 55 ()
      Antwort auf Beitrag Nr.: 56.960.318 von evotecci am 07.02.18 12:50:49Mir erschließt sich der Sinn eines 2. Threads in diesem Fall auch nicht so ganz.
      Avatar
      schrieb am 07.02.18 15:27:51
      Beitrag Nr. 56 ()
      Antwort auf Beitrag Nr.: 56.960.318 von evotecci am 07.02.18 12:50:49
      Zitat von evotecci: Wenn Du im anderen Thread schreiben würdest, müsstest Du nicht immer Selbstgespräche führen......,-))))

      Mir erschließt sich der Sinn eines 2. Threads in diesem Fall auch nicht so ganz

      OK...............sssssssoooorrrrryyyyyyy.......:look:

      Anscheinend ist der andere Thread dann doch wieder mehr zum Leben erwacht.;), nachdem in diesem Thread vom September 2017 bis Januar 2018 nichts geschrieben worden ist.

      Ich werde dann von jetzt an im anderen Thread schreiben ;)

      Und schön zu wissen, dass es doch noch andere ARRAYisten gibt.....:kiss:

      MfG
      bernie55
      18 Antworten
      Avatar
      schrieb am 07.02.18 18:04:59
      Beitrag Nr. 57 ()
      Antwort auf Beitrag Nr.: 56.961.932 von bernie55 am 07.02.18 15:27:51wow, COLUMBUS zeigt beim Überleben einen signifikanten Vorteil von ARRYs Kombitherapie gegenüber Roches B-Raf-Hemmer Vemurafenib. Obschon nicht direkt gegenüber Roches Kombi Cobimetinib/Vemurafenib verglichen wurde, scheint eine ernsthafte Konkurrenz zu entstehen.

      http://www.nejm.org/doi/full/10.1056/NEJMoa1408868
      http://www.thelancet.com/journals/lanonc/article/PIIS1470-20…

      Encorafenib and Binimetinib Combination Treatment Demonstrates 33.6 Month Median Overall Survival (OS) in Patients with BRAF-Mutant Melanoma in Phase 3 COLUMBUS Trial
      February 06, 2018

      BOULDER, Colo. and CASTRES, France, Feb. 6, 2018 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) and Pierre Fabre today announced results of the planned analysis of overall survival (OS) from the pivotal Phase 3 COLUMBUS trial in patients with BRAF-mutant melanoma. Treatment with the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily (COMBO450) reduced the risk of death compared to treatment with vemurafenib 960 mg daily [hazard ratio (HR) of 0.61, [95% CI 0.47, 0.79, p <0.001]. Median OS was 33.6 months for patients treated with COMBO450, compared to 16.9 months for patients treated with vemurafenib as a monotherapy.
      17 Antworten
      Avatar
      schrieb am 07.02.18 18:51:40
      Beitrag Nr. 58 ()
      Antwort auf Beitrag Nr.: 56.963.828 von Cyberhexe am 07.02.18 18:04:59
      https://www.streetinsider.com/Analyst+Comments/Array+BioPhar…

      Array BioPharma (ARRY) PT Raised to $23 at Stifel
      February 7, 2018 6:27 AM EST Send to a Friend
      Stifel raised its price target on Array BioPharma (NASDAQ: ARRY) to $23.00 (from $20.00) while maintaining a Buy ...
      16 Antworten
      Avatar
      schrieb am 08.02.18 10:53:03
      Beitrag Nr. 59 ()
      Antwort auf Beitrag Nr.: 56.964.506 von Cyberhexe am 07.02.18 18:51:40gute Zusammenfassung der Kombi-Studie mit Bini&Encora:

      15 Antworten
      Avatar
      schrieb am 08.02.18 13:00:12
      Beitrag Nr. 60 ()
      Antwort auf Beitrag Nr.: 56.970.380 von Cyberhexe am 08.02.18 10:53:03das Safety Profile von encorafenib+binimetinib ist günstiger als das der beiden Konkurrenz-Kombitherapien, die da wären dabrafenib/trametinib (Novartis) und cobimetinib/vemurafenib (Roche/Genentech), wobei jedoch bei den schweren Nebenwirkungen (3 und 4) keine gravierenden Unterschiede festzustellen sind.
      6 Antworten
      Avatar
      schrieb am 08.02.18 18:01:43
      Beitrag Nr. 61 ()
      Antwort auf Beitrag Nr.: 56.971.787 von Cyberhexe am 08.02.18 13:00:12die Rechte für Encorafenib/Binimetinib ausserhalb der US wurden von Array an folgende Unternehmen auslizenziert:

      EU, Korea und Südamerika --> Pierre Fabre
      Japan --> Ona Pharma

      Obschon Bini/Encora bei der Behandlung von mMelanoma innerhalb der Klasse die potenziell besten Ergebnisse liefert und auch bei den Nebenwirkungen, inssbesondere Photosensibilität und Fieber, günstiger abschneidet, halte ich die strukturellen Nachteile bei den Verkaufsorganisationen für den limitierenden Faktor bei Pierre-Fabre - da sind Roche und Novartis aus einem "anderen Holz" - und dies sollte man bei ähnlichen Produkten nicht unterschätzen.

      Beim "Bequemlichkeitsvergleich" sind die 3 Varianten einander ähnlich, lediglich Trametinib muss gekühlt werden.
      5 Antworten
      Avatar
      schrieb am 09.02.18 11:57:21
      Beitrag Nr. 62 ()
      Antwort auf Beitrag Nr.: 56.975.855 von Cyberhexe am 08.02.18 18:01:43"face to face" lässt sich aus allen mMelanoma-Studien ableiten, dass ...

      ...eine Kombitherapie aus MEK 1/2-Hemmer und BRAF-Hemmer immer besser ist als eine Monotherapie
      ...Encorafenib in Monotherapie besser abschneidet als Vemurafenib-mono.


      3.3.4. Binimetinib plus BRAFi
      Combined encorafenib and binimetinib were evaluated in the phase-Ib/II study of patients with BRAF V600-mutant MM [54 Sullivan RJ, Weber JS, Pradyuman Patel S, et al. A phase Ib/II study of BRAF inhibitor (BRAFi) encorafenib (ENCO) plus MEK inhibitor (MEKi) binimetinib (BINI) in cutaneous melanoma patients’ naive to BRAFi treatment. J Clin Oncol. 2015;33(15_suppl):9007–9007.
      [PubMed], [Web of Science ®], [Google Scholar]
      ]. Results suggested that this combination therapy has promising activity in BRAFi-naïve patients with BRAF-mutant MM (RR: 72–78%, according to encorafenib doses).

      Recently, new outcomes from the phase-III COLUMBUS trial have been demonstrated [55 Study comparing combination of LGX818 plus MEK162 versus vemurafenib and LGX818 monotherapy in BRAF mutant melanoma (COLUMBUS). NCT01909453
      [Google Scholar]
      ]. The COLUMBUS trial consisted of 921 patients with BRAF V600 mutation positive MM. In Part 1 of the study, 577 patients received encorafenib plus binimetinib, encorafenib alone, or vemurafenib alone. In the combination group, encorafenib and binimetinib were given at 450 mg QD and at 45 mg BID, respectively. Single-agent encorafenib and vemurafenib were administered at 300 mg QD and 960 mg BID, respectively. Median PFS was 14.9 months in the combination group compared with 7.3 and 9.6 months for the vemurafenib and encorafenib monotherapy arms, respectively. Also, the improvement in PFS signified a 46% reduction in the risk of progression or death. The confirmed ORR was 63% for patients receiving encorafenib plus binimetinib, vs. 51% and 40% for the encorafenib and vemurafenib monotherapy groups, respectively [55 Study comparing combination of LGX818 plus MEK162 versus vemurafenib and LGX818 monotherapy in BRAF mutant melanoma (COLUMBUS). NCT01909453
      [Google Scholar]
      ].
      1 Antwort
      Avatar
      schrieb am 09.02.18 12:16:16
      Beitrag Nr. 63 ()
      Antwort auf Beitrag Nr.: 56.982.902 von Cyberhexe am 09.02.18 11:57:21Der vollständige Artikel zu Encorafenib ist noch nicht publiziert - bisher nur der "Abstract":

      https://journals.lww.com/co-oncology/Abstract/publishahead/D…

      Development of encorafenib for BRAF-mutated advanced melanoma
      Koelblinger, Petera,b; Thuerigen, Olafc; Dummer, Reinharda

      Current Opinion in Oncology: February 1, 2018 - Volume Publish Ahead of Print - Issue - p
      doi: 10.1097/CCO.0000000000000426
      REVIEW: PDF Only

      Purpose of review To describe the pharmacological properties, preclinical and clinical data of the novel V-Raf Murine Sarcoma Viral Oncogene Homolog B (BRAF)-inhibitor encorafenib (LGX818) and to compare these with established BRAF-inhibitors in the treatment of locally advanced or metastatic melanoma.

      Recent findings Encorafenib has shown improved efficacy in the treatment of metastatic melanoma in comparison with vemurafenib. Combination with the MEK inhibitor (MEKi) binimetinib allows for higher dose intensities of encorafenib further improving response rates (RRs).

      Summary Combination therapy with BRAF and MEKi has evolved as a standard of care in the treatment of locally advanced or metastatic BRAFV600-mutated melanoma. Despite compelling initial RRs, development of treatment resistance eventually leads to tumor progression in the majority of BRAF/MEK-inhibitor treated patients. Moreover, treatment-related adverse events are frequent, resulting in a substantial proportion of dose modifications and/or treatment discontinuations. The second-generation BRAF inhibitor encorafenib has been developed aiming at improved efficacy and tolerability through modifications in pharmacological properties. Clinical phase 3 data show improved progression-free survival both for encorafenib monotherapy and combination therapy with binimetinib compared with vemurafenib. Overall survival data and regulatory approval of this novel substance are eagerly awaited.
      Avatar
      schrieb am 09.02.18 12:34:48
      Beitrag Nr. 64 ()
      Antwort auf Beitrag Nr.: 56.975.855 von Cyberhexe am 08.02.18 18:01:43
      Zitat von Cyberhexe: die Rechte für Encorafenib/Binimetinib ausserhalb der US wurden von Array an folgende Unternehmen auslizenziert:
      EU, Korea und Südamerika --> Pierre Fabre
      Japan --> Ona Pharma

      Obschon Bini/Encora bei der Behandlung von mMelanoma innerhalb der Klasse die potenziell besten Ergebnisse liefert und auch bei den Nebenwirkungen, inssbesondere Photosensibilität und Fieber, günstiger abschneidet, halte ich die strukturellen Nachteile bei den Verkaufsorganisationen für den limitierenden Faktor bei Pierre-Fabre - da sind Roche und Novartis aus einem "anderen Holz" - und dies sollte man bei ähnlichen Produkten nicht unterschätzen.

      Beim "Bequemlichkeitsvergleich" sind die 3 Varianten einander ähnlich, lediglich Trametinib muss gekühlt werden.


      Wenn dem so ist, dann sollte ein anderer BIG PHARMA - :yawn: biitteschön :yawn: - vielleicht doch die Gelegenheit nutzen und ARRAY übernehmen, um die "Produkte" dann "professioneller" auf den Markt zu bringen. Einfach mal wieder so ein Gedanke.... ;)

      Wie ich aus dem anderen Array-Forum erfahren habe, würde eine Übernahme durch ROCHE wohl aus kartellrechtlichen Gründen scheitern, da ROCHE sehr ähnliche Präparate im Portfolio hat.

      Eine Übernahme durch eine japanische Firma z.B. TAKEDA wäre auch eine Option. Bei ARIAD haben sie ja auch bereits im Jan.17 zugeschlagen, also, warum nicht auch bei ARRY ???? :)

      TIME WILL TELL
      :cool:
      2 Antworten
      Avatar
      schrieb am 09.02.18 17:06:07
      Beitrag Nr. 65 ()
      Antwort auf Beitrag Nr.: 56.983.358 von bernie55 am 09.02.18 12:34:48der Wettbewerb innerhalb der Klasse (Kombitherapie MEK-Hemmer/BRAF-Hemmer) bei der Behandlung von mMelanoma ist mit mind. 3 Kombi-Therapien ambitiös, so dass ich glaube, dass keine der Big-Pharma-Firmen Interesse daran haben wird und auch für die Kleinen ist die schwergewichtige Konkurrenz bei limitiertem Umsatzpotenzial (max. 1 Milliarde USD?) wohl eher abschreckend. Allerdings, Array hat ja noch weitere "Pfeile" im Köcher ;)
      1 Antwort
      Avatar
      schrieb am 09.02.18 17:14:24
      Beitrag Nr. 66 ()
      Antwort auf Beitrag Nr.: 56.986.478 von Cyberhexe am 09.02.18 17:06:07
      Zitat von Cyberhexe: der Wettbewerb innerhalb der Klasse (Kombitherapie MEK-Hemmer/BRAF-Hemmer) bei der Behandlung von mMelanoma ist mit mind. 3 Kombi-Therapien ambitiös, so dass ich glaube, dass keine der Big-Pharma-Firmen Interesse daran haben wird und auch für die Kleinen ist die schwergewichtige Konkurrenz bei limitiertem Umsatzpotenzial (max. 1 Milliarde USD?) wohl eher abschreckend.

      Allerdings, Array hat ja noch weitere "Pfeile" im Köcher
      ;)


      ....und deshalb hat die Überschrift deines Threads immer noch nichts an Aktualität verloren...... ;)
      Avatar
      schrieb am 09.03.18 20:18:03
      Beitrag Nr. 67 ()
      Arrays' Kombitherapie (MEKinh: Binimetinib + BRAFinh: Encorafenib) zur Behandlung von mMelanoma wird voraussichtlich im 2Q2018 von der FDA und im 3Q2018 von der EMA zugelassen;

      gegenüber Roche/Genentech (Cobimetinib + Vemurafenib) und Novartis (Trametinib+Dabrafenib) hat Arrays Kombi folgende Vorteile:

      - bei der Wirksamkeit mindestens genau so gut (besseres Ergebnis wird von der Konkurrenz mit dem Hinweis auf "gesündere" Patienten diskreditiert)
      - das beste Nebenwirkungsprofil

      Ob diese Vorteile genügen, um der übermächtigen Konkurrenz (Roche, Novartis) Marktanteile streitig zu machen, wird sich zeigen. Da die beiden anderen Therapien bereits am Markt etabliert sind und die Verkaufsorganisation von Pierre Fabre bzw. Array in Grösse und Strategie wohl massiv unterlegen sind, ist für Spannung gesorgt.
      7 Antworten
      Avatar
      schrieb am 19.03.18 19:33:15
      Beitrag Nr. 68 ()
      Antwort auf Beitrag Nr.: 57.239.080 von Cyberhexe am 09.03.18 20:18:03
      6 Antworten
      Avatar
      schrieb am 20.03.18 17:04:44
      Beitrag Nr. 69 ()
      Antwort auf Beitrag Nr.: 57.322.970 von Cyberhexe am 19.03.18 19:33:15:laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh:



      :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh: :laugh:
      5 Antworten
      Avatar
      schrieb am 03.05.18 06:19:09
      Beitrag Nr. 70 ()
      Antwort auf Beitrag Nr.: 57.332.975 von bernie55 am 20.03.18 17:04:44ASCO2018 dürfte hinsichtlich Array und deren Wirklstoffe sehr aufschlussreich werden:



      8 drugs with abstracts at #ASCO18 Encorafenib - Binimetinib - Wholly-owned by $ARRY or Selumetinib, Ipatasertib, LOXO-292, Tucatinib, Varlitinib & Prexasertib - Licensed by ArrayBiopharma
      4 Antworten
      Avatar
      schrieb am 09.05.18 14:31:00
      Beitrag Nr. 71 ()
      Antwort auf Beitrag Nr.: 57.682.281 von Cyberhexe am 03.05.18 06:19:09Array hält Kurs und mit der anstehenden Zulassung von Encorafenib/Binimetinib zur Behandlung von mMelanoma spätestens zum 30.6.2018 -an der Zulassung gibt es für mich keine Zweifel- wird Roche und Novartis zusätzliche Konkurrenz bekommen. Der Median der Überlebenszeitanalyse ist mit mOS=33.6 Monate erstaunlich.

      Im Vergleich dazu Vemurafenib (Zelboraf®)/Cobimetinib (Cotellic®) in coBRIM:
      "Median overall survival was 22.3 months (95% CI 20.3-not estimable) for cobimetinib and vemurafenib versus 17.4 months (95% CI 15.0-19.8) for placebo and vemurafenib (HR 0.70, 95% CI 0.55-0.90; p=0.005)."






      - June 30, 2018 PDUFA date for encorafenib and binimetinib NDAs in BRAF-mutant melanoma --

      -- Encorafenib and binimetinib combination achieved a median overall survival (mOS) of 33.6 months in patients with BRAF-mutant melanoma in Phase 3 COLUMBUS trial --

      -- Combination of encorafenib, binimetinib and cetuximab demonstrated an 8 month median progression-free survival (mPFS) in patients with BRAF-mutant colorectal cancer (CRC) in updated safety lead-in results from Phase 3 BEACON CRC trial --

      -- Cash, Cash Equivalents and Marketable Securities as of March 31, 2018 were $440 million --

      BOULDER, Colo., May 9, 2018 /PRNewswire/ -- Array BioPharma Inc., (ARRY) today reported results for its third quarter of fiscal 2018 and provided an update on the progress of its key clinical development programs.

      "Preparations for the anticipated U.S. launch of encorafenib and binimetinib in BRAF-mutant melanoma are well underway," said Ron Squarer, Chief Executive Officer. "We are pleased to have our entire commercial leadership and infrastructure in place and are poised for an exciting 2018, as we look ahead to commercialization and additional data updates from our encorafenib and binimetinib clinical trials."

      COLUMBUS PHASE 3 TRIAL
      Regulatory
      Array's New Drug Applications (NDAs) to support use of the encorafenib and binimetinib combination for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma remain under review by the FDA with a target action date under Prescription Drug User Fee Act (PDUFA) of June 30, 2018.

      The European Medicines Agency (EMA), as well as the Swiss Medicines Agency (Swissmedic) and the Australian Therapeutic Goods Administration (TGA), are reviewing the Marketing Authorization Applications (MAAs) submitted by Pierre Fabre and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has accepted the Manufacturing and Marketing Approval (MMA) applications submitted by Ono Pharmaceutical Co, Ltd.

      The regulatory submissions were based on findings from the pivotal Phase 3 COLUMBUS trial.

      COLUMBUS Median Overall Survival Results
      Array will announce additional results from the Phase 3 COLUMBUS trial in an oral presentation (Abstract #223875) at the American Society of Clinical Oncology 2018 Annual Meeting on June 4.

      Array previously announced that treatment with the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily (COMBO450) reduced the risk of death compared to treatment with vemurafenib 960 mg daily [hazard ratio (HR) of 0.61, (95% CI 0.47, 0.79, p<0.001)] in patients with BRAF-mutant melanoma in the Phase 3 COLUMBUS trial.

      The Phase 3 trial showed mOS of 33.6 months for patients treated with COMBO450, compared to 16.9 months for patients treated with vemurafenib as a monotherapy.
      As previously reported, the combination of encorafenib and binimetinib was generally well-tolerated. Grade 3/4 adverse events (AEs) that occurred in more than 5% of patients receiving the combination were increased gamma-glutamyltransferase (GGT) (9%), increased blood creatine phosphokinase (CK) (7%) and hypertension (6%). The incidence of selected any grade AEs of special interest, defined based on toxicities commonly associated with commercially available BRAF+MEK-inhibitor treatments for patients receiving the combination of encorafenib and binimetinib included: rash (22%), pyrexia (18%), serous retinopathy including retinal pigment epithelial detachment (20%) and photosensitivity (5%). Full safety results of COLUMBUS Part 1 were published in The Lancet Oncology.
      The Lancet Oncology Publication
      Detailed results of the pivotal Phase 3 COLUMBUS trial for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma were published online on March 21, 2018 and in the May 2018 print edition of The Lancet Oncology.

      BEACON CRC PHASE 3 TRIAL
      Array will present updated results from the 30 patient safety lead-in of the Phase 3 BEACON CRC trial at the ESMO 20th World Congress on Gastrointestinal Cancer June 20-23, 2018.

      Array previously announced updated results from the 30 patient safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, binimetinib and cetuximab, an EGFR antagonist, in patients with BRAF-mutant CRC whose disease has progressed after one or two prior regimens at the ASCO 2018 Gastrointestinal Cancers Symposium.

      The estimated mPFS at the time of analysis was 8 months in 29 patients with BRAFV600E-mutant CRC.
      The confirmed overall response rate (ORR) was 48% with 3 complete responses in patients with BRAFV600E-mutant CRC. Further, the ORR was 62% in the 16 patients who received only one prior line of therapy.
      These data represent improvements compared to several approved standard of care benchmarks for this population which range between 4% to 8% ORR and 1.8 and 2.5 months mPFS. [1-4]
      The triplet combination was generally well-tolerated. Two patients discontinued treatment due to AEs with only one of these considered related to treatment. The most common grade 3 or 4 AEs seen in at least 10% of patients were fatigue, urinary tract infection, increased aspartate aminotransferase (AST) and increased blood CK.
      Enrollment in the randomized portion of BEACON CRC is ongoing. BRAF mutations are estimated to occur in 10% to 15% of patients with CRC and represent a poor prognosis for these patients.
      Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.

      IMMUNO-ONCOLOGY COLLABORATIONS: TRIALS ADVANCING WITH BRISTOL-MYERS SQUIBB AND MERCK; TRIAL WITH PFIZER EXPECTED TO START THIRD QUARTER OF 2018
      Array is developing binimetinib in combination with PD-1/ PD-L1 checkpoint inhibitors and has announced separate, strategic collaborations with Bristol-Myers Squibb, Merck and Pfizer, but in each case, are pursuing a unique trial design to explore different clinical approaches.

      Bristol-Myers Squibb

      The clinical trial continues to advance and is designed to investigate the safety, tolerability and efficacy of binimetinib in combination with nivolumab (anti-PD-1 therapy), with and without ipilimumab (CTLA-4 antibody), in patients with advanced metastatic microsatellite stable (MSS) CRC and the presence of a RAS mutation who have received one or two prior regimens.
      The trial is jointly supported by Array and Bristol-Myers Squibb and sponsored by Array.
      Merck

      The clinical trial continues to advance and is designed to investigate the safety, tolerability and efficacy of binimetinib in combination with pembrolizumab (anti-PD-1 therapy), with and without FOLFOX or FOLFIRI (chemotherapy) in patients with CRC whose tumors are not microsatellite instability-high (MSI-H).
      The trial is sponsored and funded by Merck, with Array providing binimetinib supply.
      Pfizer

      The clinical trial is designed to investigate the safety, tolerability and efficacy of several novel anti-cancer combinations, including binimetinib, avelumab (anti-PD-L1 therapy) and talazoparib (PARP inhibitor) across various tumor types and is expected to begin during the third quarter of 2018.
      Initially, the focus will be in non-small cell lung cancer (NSCLC) and pancreatic cancer, with additional indications being explored at a later stage.
      The trial will be sponsored and funded by Pfizer, with Array providing binimetinib supply.
      FINANCIAL HIGHLIGHTS
      Novartis Financial Commitment
      Novartis continues to substantially fund all ongoing trials with encorafenib and binimetinib that were active or planned as of the close of the Novartis Agreements in 2015, including the COLUMBUS Phase 3 trial. Reimbursement revenue from Novartis was approximately $87 million for the 12 months ended March 31, 2018, of which $24.8 million was recorded in the quarter ended March 31, 2018. Total revenue and upfront payment collected from Novartis since the start of the 2015 agreement is $373.5 million.
      Avatar
      schrieb am 09.05.18 14:53:57
      Beitrag Nr. 72 ()
      Array BioPharma: Fiscal 3Q Earnings Snapshot

      Associated Press•May 9, 2018

      BOULDER, Colo. (AP) _ Array BioPharma Inc. (ARRY) on Wednesday reported a loss of $22.9 million in its fiscal third quarter.

      The Boulder, Colorado-based company said it had a loss of 11 cents per share.

      The results exceeded Wall Street expectations. The average estimate of seven analysts surveyed by Zacks Investment Research was for a loss of 22 cents per share.

      The drug developer posted revenue of $66.4 million in the period, which also topped Street forecasts. Four analysts surveyed by Zacks expected $32.1 million.

      Array BioPharma shares have risen slightly more than 6 percent since the beginning of the year. The stock has risen 96 percent in the last 12 months.

      https://finance.yahoo.com/news/array-biopharma-fiscal-3q-ear…
      Avatar
      schrieb am 17.05.18 15:43:01
      Beitrag Nr. 73 ()
      Antwort auf Beitrag Nr.: 57.682.281 von Cyberhexe am 03.05.18 06:19:09
      Zitat von Cyberhexe: ASCO2018 dürfte hinsichtlich Array und deren Wirklstoffe sehr aufschlussreich werden:

      8 drugs with abstracts at #ASCO18 Encorafenib - Binimetinib - Wholly-owned by $ARRY or Selumetinib, Ipatasertib, LOXO-292, Tucatinib, Varlitinib & Prexasertib - Licensed by ArrayBiopharma



      Array BioPharma Announces Oral Presentation from the Pivotal Phase 3 COLUMBUS trial of the Combination of Encorafenib and Binimetinib in Patients with BRAF-mutant Melanoma at 2018 ASCO Annual Meeting

      Mon, Jun 04
      9:12 AM - 9:24 AM

      Abstract 9504
      Overall survival in COLUMBUS: A phase 3 trial of encorafenib (ENCO) plus binimetinib (BINI) vs vemurafenib (VEM) or enco in BRAF-mutant melanoma.
      Reinhard Dummer, MD - First Author
      University of Zurich Hospital, Department of Dermatology


      -------------------------------------------------------------------------------------------------------------------


      8 drugs with abstracts at #ASCO18


      Sat, Jun 02
      4:00 PM - 4:12 PM

      Abstract 10503
      SPRINT: Phase II study of the MEK 1/2 inhibitor selumetinib (AZD6244, ARRY-142886) in children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN).
      Andrea M. Gross, MD, BS - First Author
      National Institutes of Health


      Sat, Jun 02
      8:36 AM - 8:48 AM

      Abstract 102
      A phase 1 study of LOXO-292, a potent and highly selective RET inhibitor, in patients with RET-altered cancers.
      Alexander E. Drilon, MD - First Author
      Memorial Sloan Kettering Cancer Center


      Sat, Jun 02
      8:00 AM - 11:30 AM

      Poster Board: #96 • Abstract 1015
      Clinical benefit of tucatinib after isolated brain progression: A retrospective pooled analysis of tucatinib phase 1b studies in HER2+ breast cancer.
      Rashmi Krishna Murthy, MD - First Author
      University of Texas MD Anderson Cancer Center

      Discussed at the Poster Discussion Session on Saturday, June 2, 2018, 1:15 PM - 2:30 PM, at Hall D1


      Sat, Jun 02
      8:00 AM - 11:30 AM

      Poster Board: #189b • Abstract TPS1117
      IPATunity130: A pivotal randomized phase III trial evaluating ipatasertib (IPAT) + paclitaxel (PAC) for PIK3CA/AKT1/PTEN-altered advanced triple-negative (TN) or hormone receptor-positive HER2-negative (HR+/HER2–) breast cancer (BC).
      Rebecca Alexandra Dent, MD - First Author
      National Cancer Center


      Sun, Jun 03,
      8:00 AM - 11:30 AM

      Poster Board: #268 • Abstract 4079
      Phase Ib study of binimetinib (MEK162) in combination with capecitabine in gemcitabine-pretreated advanced biliary tract cancer.
      Jin Won Kim, MD, PhD - First Author
      Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine


      Sun, Jun 03
      8:00 AM - 11:30 AM

      Poster Board: #326a • Abstract TPS4143
      TREETOPP: A phase 2/3 study of varlitinib plus capecitabine versus placebo plus capecitabine as second-line treatment in patients with advanced or metastatic biliary tract cancers (BTCs).
      Milind M. Javle, MD - First Author
      University of Texas MD Anderson Cancer Center


      Mon, Jun 04
      8:00 AM - 11:30 AM

      Poster Board: #405 • Abstract 2579
      A phase 1b dose-escalation study of prexasertib, a checkpoint kinase 1 (CHK1) inhibitor, in combination with cisplatin in patients with advanced cancer.
      Manish R. Patel, MD - First Author
      Florida Cancer Specialists/Sarah Cannon Research Institute


      https://am.asco.org/program
      2 Antworten
      Avatar
      schrieb am 24.05.18 08:04:56
      Beitrag Nr. 74 ()
      Antwort auf Beitrag Nr.: 57.782.029 von bernie55 am 17.05.18 15:43:01Das Ergebnis von LOTUS wird sicherlich für sehr viel Aufmerksamkeit sorgen - Design der ph3 wird bereits auf ASCO18 vorgestellt:

      Overall survival (OS) update of the double-blind placebo (PBO)-controlled randomized phase 2 LOTUS trial of first-line ipatasertib (IPAT) + paclitaxel (PAC) for locally advanced/metastatic triple-negative breast cancer (mTNBC).
      Presented Sunday, June 3, 2018



      https://meetinglibrary.asco.org/record/160552/abstract
      1 Antwort
      Avatar
      schrieb am 05.06.18 19:46:08
      Beitrag Nr. 75 ()
      Antwort auf Beitrag Nr.: 57.820.148 von Cyberhexe am 24.05.18 08:04:56es ist mehr erstaunlich, wieviele Wirkstoffe die Pipeline von Array bereits hevorgebracht hat, unter anderem die beiden ASCO-Stars --> 2017 Larotrectinib sowie derjenige von 2018 --> LOXO-292 von LOXO Oncology:




      im Fokus steht derzeit dennoch die Zulassungsentscheidung von Bini/Encorafenib beim schwarzen Hautkrebs ( mMelanoma).
      Avatar
      schrieb am 07.06.18 18:15:57
      Beitrag Nr. 76 ()
      Antwort auf Beitrag Nr.: 56.970.380 von Cyberhexe am 08.02.18 10:53:03
      Zitat von Cyberhexe: gute Zusammenfassung der Kombi-Studie mit Bini&Encora:




      Bis Ende des Monats hat die FDA über den Zulassungsantrag con Bini/Enorafenib zur Behandlung von mMelanoma zu entscheiden. Ich denke, die Zulassung sollte lediglich Formsache sein, zu gut sind die Ergebnisse der COLUMBUS-Studie.

      Da auch das Nebenwirkungsprofil (inssbesondere Photosensibilität und Fieber) von encorafenib+binimetinib günstiger ist als das der beiden Konkurrenz-Kombitherapien, die da wären dabrafenib/trametinib (Novartis) und cobimetinib/vemurafenib (Roche/Genentech) - jedoch keine gravierenden Unterschiede bei den schweren Nebenwirkungen (3 und 4) - sollte diese neue Kombitherapie trotz der schwergewichtigen Schweizer Konkurrenz Marktanteile gewinnen.


      Die Rechte für Encorafenib/Binimetinib ausserhalb der US wurden von Array an folgende Unternehmen auslizenziert: EU, Korea und Südamerika --> Pierre Fabre
      Japan --> Ona Pharma

      Obschon Bini/Encorafenib bei der Behandlung von mMelanoma innerhalb der Klasse die potenziell besten Ergebnisse liefert, wird der strukturelle Nachteil bei den Verkaufsorganisationen jedoch den Marktanteil dieser neuen Therapie beschränken - Roche und Novartis spielen da in einer anderen Liga als Pierre Fabre.
      7 Antworten
      Avatar
      schrieb am 13.06.18 21:21:37
      Beitrag Nr. 77 ()
      Antwort auf Beitrag Nr.: 54.367.383 von Cyberhexe am 20.02.17 19:26:09
      Zitat von Cyberhexe: Freddy, du hast dich nach meinen Tipps für 2017 erkundigt: einer davon ist ARRY


      Pipeline:
      http://www.arraybiopharma.com/product-pipeline/


      ausgezeichnete Ergebnisse in COLUMBUS:

      COLUMBUS Phase 3 Study Results in BRAF-Mutant Melanoma Presented at Society for Melanoma Research Annual Congress
      - Binimetinib plus encorafenib meets primary endpoint with statistically significant advantage on median PFS of 14.9 months versus 7.3 months for vemurafenib monotherapy -
      - Additional PFS, ORR and durability data support primary endpoint result -
      - Detailed safety and drug exposure data presented; combination of binimetinib plus encorafenib demonstrates a favorable tolerability profile -
      BOULDER, Colo., and CASTRES, France, Nov. 9, 2016 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) and Pierre Fabre today jointly announced new results from the pivotal Phase 3 COLUMBUS trial of binimetinib plus encorafenib (bini/enco) treatment in BRAF-mutant melanoma patients at the Society for Melanoma Research Annual Congress. The study met its primary endpoint, with the combination of bini/enco significantly improving progression free survival (PFS) compared with vemurafenib, a BRAF inhibitor, alone. The combination of bini/enco was generally well-tolerated and reported adverse events (AEs) were overall consistent with previous published clinical trial results for the bini/enco combination in BRAF-mutant melanoma patients.


      Einstiegskurs/Empfehlungskurs am 29.11.2016 USD 8.23



      PDUFA Bini/Encorafenib zur Behandlung von mMelanoma: 30.Juni 2018

      Avatar
      schrieb am 19.06.18 13:10:31
      Beitrag Nr. 78 ()
      Array BioPharma to Present Overall Survival Results from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant Colorectal Cancer at the ESMO 20th World Congress on Gastrointestinal Cancer



      BOULDER, Colo., June 18, 2018 /PRNewswire/ -- Array BioPharma Inc. (ARRY) announced that it will present updated safety and efficacy results, including overall survival (OS) data, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF-mutant colorectal cancer (CRC). These data will be featured in an oral presentation on Saturday, June 23, at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain.

      Oral Presentation BEACON CRC Safety Lead-In



      Title:


      BEACON CRC Study Safety Lead-in: Assessment of the BRAF Inhibitor Encorafenib + MEK Inhibitor Binimetinib + Anti–Epidermal Growth Factor Receptor Antibody Cetuximab for BRAFV600E Metastatic Colorectal Cancer

      Presenter:

      Eric Van Cutsem, M.D., Professor, Internal Medicine, Head, Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven

      Abstract:

      O-027

      Session:


      Session XX

      Date:

      Saturday, June 23

      Session Time:


      11:40 a.m. – 12:20 p.m. CET (5:40 – 6:20 a.m. ET)

      Location:

      Auditorium A

      Following the presentation, the slides will be available as a PDF on Array's website at www.arraybiopharma.com.

      Array will host an encore webcast presentation of the BEACON CRC safety lead-in trial data.



      Encore Investor Webcast:

      Presenter:

      Axel Grothey, M.D., Division of Hematology/Oncology, Mayo Clinic

      Date:

      Saturday, June 23

      Time:


      4:30 pm CET (10:30 am ET)

      Toll-Free:

      (844) 464-3927

      Toll:

      (765) 507-2598

      Pass Code:

      8588348

      Webcast, including replay and conference call slides: https://edge.media-server.com/m6/p/bn2j2g45


      https://finance.yahoo.com/news/array-biopharma-present-overa…
      9 Antworten
      Avatar
      schrieb am 19.06.18 23:37:14
      Beitrag Nr. 79 ()
      Antwort auf Beitrag Nr.: 58.017.250 von bernie55 am 19.06.18 13:10:31das dürfte noch ein ganz starker JUNI für Array werden, da nebst BEACON-CRC bei Dickdarmkrebs gute Nachrichten von der FDA hinsichtlich Bini/Encorafenib-Zulassung bei mMelanoma am 30.Juni erwartet werden.
      5 Antworten
      Avatar
      schrieb am 21.06.18 11:46:04
      Beitrag Nr. 80 ()
      Antwort auf Beitrag Nr.: 58.022.098 von Cyberhexe am 19.06.18 23:37:14
      Zitat von Cyberhexe: das dürfte noch ein ganz starker JUNI für Array werden, da nebst BEACON-CRC bei Dickdarmkrebs gute Nachrichten von der FDA hinsichtlich Bini/Encorafenib-Zulassung bei mMelanoma am 30.Juni erwartet werden.


      Wenn die Resultate so positiv ausfallen wie wir uns das erhoffen, dann könnte das ab diesem Monat der Anfang einer "Big Story" sein , frei nach dem Motte : It's only the beginning :)

      TIME WILL TELL :cool:
      4 Antworten
      Avatar
      schrieb am 24.06.18 21:47:31
      Beitrag Nr. 81 ()
      Antwort auf Beitrag Nr.: 58.017.250 von bernie55 am 19.06.18 13:10:31Array BioPharma Announces a 62% Observed Overall Survival at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO 20th World Congress on Gastrointestinal Cancer

      PR NewswireJune 23, 2018

      - Median Overall Survival (mOS) was not reached; OS data are fully mature through 12.6 months -

      - Encore investor webcast today at 10:30 am Eastern Time -

      BOULDER, Colo., June 23, 2018 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAFV600E-mutant metastatic colorectal cancer (CRC). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO 20thWorld Congress on Gastrointestinal Cancer in Barcelona, Spain. 

      The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines of therapy. The confirmed overall response rate (ORR) was 48% and among the 17 patients who received only one prior line of therapy the ORR was 62%.

      "The results of the BEACON CRC safety lead-in demonstrate substantial improvements in efficacy outcomes when compared to current approved standard of care benchmarks in patients with BRAF-mutant metastatic CRC. The median progression-free survival of 8 months is a meaningful improvement compared to the benchmark of about 2 months, and the overall survival of 62% at 12 months is very promising given that with current approved standards of care, half of patients will succumb to their disease within 4 to 6 months," saidAxel Grothey, M.D., Division of Hematology/Oncology, Mayo Clinic. "These data underscore the potential of this triplet combination to benefit patients with BRAFV600E-mutant metastatic CRC, who, despite their poor prognosis, currently have limited effective treatment options."

      The triple combination was generally well-tolerated with no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue (13%), anemia (10%), increased blood creatine kinase (10%) and increased aspartate aminotransferase (10%).

      The presentation also referenced updated, mature Phase 2 results for the doublet of encorafenib and cetuximab that showed a mOS of 9.3 months, mPFS of 4.2 months and an ORR of 24%. The data cutoff for that analysis was January 2018 with the last patient enrolled in April of 2015; a detailed presentation of these data will occur at a future medical congress.

      Enrollment in the randomized portion of the BEACON CRC trial is ongoing. Patients interested in participating in this trial may talk to their doctor to have their tumor tested for the BRAF mutation for eligibility to enroll in this new and important trial. Further details on the trial are available at clinicaltrials.gov (NCT02928224).

      A PDF of the ESMO World Congress on Gastrointestinal Cancer presentation will be available on Array's website.


      https://finance.yahoo.com/news/array-biopharma-announces-62-…
      2 Antworten
      Avatar
      schrieb am 24.06.18 22:09:54
      Beitrag Nr. 82 ()
      Antwort auf Beitrag Nr.: 58.056.595 von bernie55 am 24.06.18 21:47:31
      Avatar
      schrieb am 24.06.18 22:16:23
      Beitrag Nr. 83 ()
      Antwort auf Beitrag Nr.: 58.056.595 von bernie55 am 24.06.18 21:47:31A PDF of the ESMO World Congress on Gastrointestinal Cancer presentation will be available onArray's website.

      http://www.arraybiopharma.com/files/9515/2975/2670/BEACON_SL…
      Avatar
      schrieb am 27.06.18 22:38:06
      Beitrag Nr. 84 ()
      Antwort auf Beitrag Nr.: 57.934.743 von Cyberhexe am 07.06.18 18:15:57
      Zitat von Cyberhexe: Bis Ende des Monats hat die FDA über den Zulassungsantrag con Bini/Enorafenib zur Behandlung von mMelanoma zu entscheiden. Ich denke, die Zulassung sollte lediglich Formsache sein, zu gut sind die Ergebnisse der COLUMBUS-Studie.

      Da auch das Nebenwirkungsprofil (inssbesondere Photosensibilität und Fieber) von encorafenib+binimetinib günstiger ist als das der beiden Konkurrenz-Kombitherapien, die da wären dabrafenib/trametinib (Novartis) und cobimetinib/vemurafenib (Roche/Genentech) - jedoch keine gravierenden Unterschiede bei den schweren Nebenwirkungen (3 und 4) - sollte diese neue Kombitherapie trotz der schwergewichtigen Schweizer Konkurrenz Marktanteile gewinnen.


      Die Rechte für Encorafenib/Binimetinib ausserhalb der US wurden von Array an folgende Unternehmen auslizenziert: EU, Korea und Südamerika --> Pierre Fabre
      Japan --> Ona Pharma

      Obschon Bini/Encorafenib bei der Behandlung von mMelanoma innerhalb der Klasse die potenziell besten Ergebnisse liefert, wird der strukturelle Nachteil bei den Verkaufsorganisationen jedoch den Marktanteil dieser neuen Therapie beschränken - Roche und Novartis spielen da in einer anderen Liga als Pierre Fabre.


      Voila!
      Soeben wurde die erwartete Zulassung der Kombitherapie BINIMETINIB/ENCORAFENIB zur Behandlung von mMelanoma veröffentlicht:

      http://investor.arraybiopharma.com/news-releases/news-releas…

      Doch noch ein guter Tag...trotz des erschreckenden Auftretens "der Mannschaft".
      6 Antworten
      Avatar
      schrieb am 29.06.18 11:27:30
      Beitrag Nr. 85 ()
      Antwort auf Beitrag Nr.: 58.083.052 von Cyberhexe am 27.06.18 22:38:06Naja, ein guter Tag (in einem Invest) sieht bei mir anders aus;)
      5 Antworten
      Avatar
      schrieb am 29.06.18 16:59:26
      Beitrag Nr. 86 ()
      Antwort auf Beitrag Nr.: 58.096.840 von Gustl24 am 29.06.18 11:27:30
      Zitat von Gustl24: Naja, ein guter Tag (in einem Invest) sieht bei mir anders aus;)



      nun ja, bei einem Investment in ein Unternehmen sind die fundamentalen Daten desselben von grösster Bedeutung - und mit der Zulassung von Bini/Encorafenib haben sich diese, auch wenn dies so erwartet wurde, nachhaltig verbessert. Die kurzfristige Kurs-Reaktion ("sell on good news") ist eher nebensächlich, wenn die mittel-bis langfristige Perspektive des Unternehmens sich massiv verbessert hat und die Aktie aufgrund der üppig gefüllten Pipeline zudem längerfristig gehalten wird.
      4 Antworten
      Avatar
      schrieb am 02.07.18 18:57:24
      Beitrag Nr. 87 ()
      Antwort auf Beitrag Nr.: 58.100.401 von Cyberhexe am 29.06.18 16:59:26weniger schön: CEO macht Kasse und verkauft nahezu die Hälfte seiner Aktien!!

      https://www.sec.gov/Archives/edgar/data/1100412/000156218018…
      3 Antworten
      Avatar
      schrieb am 02.07.18 22:18:34
      Beitrag Nr. 88 ()
      Antwort auf Beitrag Nr.: 58.118.372 von Cyberhexe am 02.07.18 18:57:24Für mich eigentlich nicht so wichtig. Wenn ich es richtig verstanden habe, dann hingen diese Aktien unmittelbar mit der Zulassung von Bini und Enco zusammen. Das vesting lief daher wohl vorbestimmt zu genau diesem Zeitpunkt als Prämie.
      2 Antworten
      Avatar
      schrieb am 04.07.18 07:38:37
      Beitrag Nr. 89 ()
      Antwort auf Beitrag Nr.: 58.120.244 von lawmeetstax am 02.07.18 22:18:34Ganz wichtig, die Label zu Bini/Encorafenib sind "sauber":

      https://www.fda.gov/drugs/informationondrugs/approveddrugs/u…

      siehe -->
      The recommended doses are binimetinib 45 mg orally twice daily and encorafenib 450 mg orally once daily.

      View full prescribing information for BRAFTOVI.

      View full prescribing information for MEKTOVI.
      1 Antwort
      Avatar
      schrieb am 04.07.18 13:26:57
      Beitrag Nr. 90 ()
      Antwort auf Beitrag Nr.: 58.131.653 von Cyberhexe am 04.07.18 07:38:37
      Zitat von Cyberhexe: Ganz wichtig, die Label zu Bini/Encorafenib sind "sauber":

      https://www.fda.gov/drugs/informationondrugs/approveddrugs/u…

      siehe -->
      The recommended doses are binimetinib 45 mg orally twice daily and encorafenib 450 mg orally once daily.

      View full prescribing information for BRAFTOVI.

      View full prescribing information for MEKTOVI.


      Das klingt doch sauber :) :cool:
      Avatar
      schrieb am 24.07.18 09:13:26
      Beitrag Nr. 91 ()
      Committee for medicinal products for human use (CHMP)

      Draft agenda for the meeting on 23-26 July 2018

      Chair: Tomas Salmonson – Vice-Chair: Harald Enzmann
      23 July 2018, 13:00 – 19:30, room 2A
      24 July 2018, 08:30 – 19:30, room 2A
      25 July 2018, 08:30 – 19:30, room 2A
      26 July 2018, 08:30 – 15:00, room 2A





      http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/…
      Avatar
      schrieb am 24.07.18 09:19:07
      Beitrag Nr. 92 ()
      Antwort auf Beitrag Nr.: 58.033.882 von bernie55 am 21.06.18 11:46:04
      Zitat von bernie55:
      Zitat von Cyberhexe: das dürfte noch ein ganz starker JUNI für Array werden, .......


      Wenn die Resultate so positiv ausfallen wie wir uns das erhoffen, dann könnte das ab diesem Monat der Anfang einer "Big Story" sein , frei nach dem Motte : It's only the beginning :)

      TIME WILL TELL :cool:




      3 Antworten
      Avatar
      schrieb am 27.07.18 14:38:22
      Beitrag Nr. 93 ()
      Antwort auf Beitrag Nr.: 58.284.818 von bernie55 am 24.07.18 09:19:07:) The CHMP recommended granting marketing authorisations for four cancer medicines: Braftovi (encorafenib) and Mektovi (binimetinib)! :)

      http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_e…
      2 Antworten
      Avatar
      schrieb am 27.07.18 20:29:29
      Beitrag Nr. 94 ()
      Antwort auf Beitrag Nr.: 58.318.481 von bernie55 am 27.07.18 14:38:22
      Zitat von bernie55: :) The CHMP recommended granting marketing authorisations for four cancer medicines: Braftovi (encorafenib) and Mektovi (binimetinib)! :)

      http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_e…


      prima....läuft alles planmässig!
      gruss aus "Vizeweltmeisterland"
      ch

      ...bin mit Infrastruktur verreist - PGNX ist dann doch zu heiss...noch heisser als das Klima ;)
      1 Antwort
      Avatar
      schrieb am 08.08.18 15:25:55
      Beitrag Nr. 95 ()
      Antwort auf Beitrag Nr.: 58.321.493 von Cyberhexe am 27.07.18 20:29:29
      die guten Nachrichten haben kein Ende - weiter so!


      ARRAY BIOPHARMA RECEIVES FDA BREAKTHROUGH THERAPY DESIGNATION FOR BRAFTOVI™ IN COMBINATION WITH MEKTOVI® AND CETUXIMAB FOR BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER
      - Designation based on Phase 3 BEACON CRC safety lead-in data -
      BOULDER, Colo., Aug. 7, 2018 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ: ARRY) today announced it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for encorafenib (BRAFTOVI™), in combination with binimetinib (MEKTOVI®) and cetuximab for the treatment of patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) as detected by an FDA-approved test, after failure of one to two prior lines of therapy for metastatic disease. BRAFV600E-mutant mCRC patients have a mortality risk more than double that of mCRC patients without the mutation, and currently there are no therapies specifically approved for this high unmet need population. [1-6]

      Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that they may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

      "We are delighted that the FDA has recognized the potential of this combination for patients with BRAFV600E-mutant metastatic colorectal cancer," said Victor Sandor, M.D., Chief Medical Officer. "As there are no regimens approved specifically for BRAFV600E-mutant mCRC, this designation provides us with the opportunity to work closely with the FDA to potentially accelerate our effort to bring an important treatment option to these patients in critical need."

      As presented at the ESMO 20thWorld Congress on Gastrointestinal Cancer in June 2018, the results from the safety lead-in of the ongoing randomized Phase 3 BEACON CRC trial showed that, at the time of analysis, the overall survival (OS) data were fully mature through 12.6 months and that the median OS had not yet been reached.

      One-year overall survival rate for this cohort was 62%.
      Median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines of therapy.
      Confirmed overall response rate (ORR) was 48% and among the 17 patients who received only one prior line of therapy the ORR was 62%.
      The triplet combination was generally well-tolerated with no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue (13%), anemia (10%), increased blood creatine kinase (10%) and increased aspartate aminotransferase (10%).
      The triplet combination of BRAFTOVI, MEKTOVI and cetuximab for the treatment of patients with BRAFV600E-mutant metastatic colorectal cancer is investigational and not approved by the FDA.


      http://investor.arraybiopharma.com/news-releases/news-releas…
      Avatar
      schrieb am 04.09.18 11:40:35
      Beitrag Nr. 96 ()
      Array BioPharma at the Wells Fargo Securities 2018 Healthcare Conference

      Date : September 6

      Time : 3:05 p.m. EDT

      http://investor.arraybiopharma.com/events/event-details/arra…
      https://event.webcasts.com/starthere.jsp?ei=1205707&tp_key=0…" target="_blank" rel="nofollow ugc noopener">
      https://event.webcasts.com/starthere.jsp?ei=1205707&tp_key=0…
      Avatar
      schrieb am 13.09.18 14:50:08
      Beitrag Nr. 97 ()
      Array BioPharma Announces Publication of BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) Phase 3 Overall Survival Data in The Lancet Oncology

      PR Newswire•September 13, 2018

      - BRAFTOVI + MEKTOVI demonstrated a median overall survival of 33.6 months in patients with advanced BRAF-mutant melanoma in Phase 3 COLUMBUS trial -




      https://finance.yahoo.com/news/array-biopharma-announces-pub…
      Avatar
      schrieb am 20.09.18 13:07:58
      Beitrag Nr. 98 ()
      Loxo Oncology Announces Accepted Abstracts at the 88th Annual Meeting of the American Thyroid Association


      Sept 18, 2018 6:45 a.m. ET

      Loxo Oncology, Inc. LOXO, -1.17% a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, today announced that abstracts from its LOXO-292 and larotrectinib programs have been accepted for oral presentations at the 88 [th] Annual Meeting of the American Thyroid Association to be held October 3-7, 2018, in Washington, DC.
      The LOXO-292 oral presentation will provide an updated analysis of patients with RET mutant medullary thyroid cancer and RET fusion thyroid cancers enrolled in the dose escalation cohorts of the ongoing LIBRETTO-001 Phase 1/2 clinical trial. The larotrectinib oral presentation will provide an analysis of patients with TRK fusion thyroid cancer enrolled to the larotrectinib clinical program.

      The schedule for the presentations is as follows:

      Larotrectinib OralPresentation Session Date & Time: October 4, 2018, 1:50 p.m.-2:05 p.m. ET
      Title: Activity of Larotrectinib in Patients with Advanced TRK Fusion Thyroid Cancer
      Session Title: Thursday Clinical Oral Abstracts
      Presenter: Marcia S. Brose, M.D., Ph.D.

      LOXO-292 OralPresentation Session Date & Time: October 6, 2018, 9:05 a.m.-9:20 a.m. ET
      Title: Clinical Activity of LOXO-292, a Highly Selective RET Inhibitor, in Patients with RET-Altered Thyroid Cancers
      Session Title: Clinical Short Call Oral
      Presenter: Lori J. Wirth, M.D.



      https://www.marketwatch.com/press-release/loxo-oncology-anno…
      Avatar
      schrieb am 30.10.18 14:59:22
      Beitrag Nr. 99 ()
      Array BioPharma Reports Financial Results for the First Quarter of Fiscal 2019

      PR Newswire PR Newswire•October 30, 2018


      - Strong launch quarter for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in U.S. with $14 million in net sales -

      - European Commission approves BRAFTOVI + MEKTOVI for advanced BRAF-mutant melanoma -

      - COLUMBUS Phase 3 Trial Overall Survival Results Published in the Lancet Oncology -

      - Cash, Cash Equivalents and Marketable Securities as of September 30, 2018 were $415 million -

      https://finance.yahoo.com/news/array-biopharma-reports-finan…
      Avatar
      schrieb am 07.11.18 10:49:52
      Beitrag Nr. 100 ()
      Array BioPharma to Present at the Stifel 2018 Healthcare Conference and the Jefferies 2018 London Healthcare Conference

      PR Newswire PR Newswire•November 6, 2018

      BOULDER, Colo., Nov. 6, 2018 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced that its Chief Executive Officer, Ron Squarer, will speak at the Stifel 2018 Healthcare Conference and the Jefferies 2018 London Healthcare Conference. The public is welcome to participate in the conferences through webcasts on the Array BioPharma website.


      Stifel 2018 Healthcare Conference
      Presenter:
      Ron Squarer, Chief Executive Officer, Array BioPharma

      Date:
      Tuesday, November 13, 2018

      Time:

      3:30 p.m. Eastern Time

      Webcast:
      http://wsw.com/webcast/stifel14/arry/




      Jefferies 2018 London Healthcare Conference
      Presenter:
      Ron Squarer, Chief Executive Officer, Array BioPharma

      Date:
      Thursday, November 15, 2018

      Time:
      9:00 a.m. Eastern Time

      Webcast:
      http://wsw.com/webcast/jeff115/arry/


      https://finance.yahoo.com/news/array-biopharma-present-stife…
      Avatar
      schrieb am 03.01.19 11:13:30
      Beitrag Nr. 101 ()
      Array BioPharma to Present at the 37th Annual J.P. Morgan Healthcare Conference

      PR Newswire PR Newswire•December 20, 2018

      BOULDER, Colo., Dec. 20, 2018 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced that its Chief Executive Officer, Ron Squarer, will speak at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco. The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

      Event:
      37th Annual J.P. Morgan Healthcare Conference

      Presenter:
      Ron Squarer, Chief Executive Officer, Array BioPharma

      Date:
      Monday, January 7, 2019

      Time:
      11:30 a.m. Pacific Time


      Presentation Webcast:
      https://jpmorgan.metameetings.net/events/healthcare19/sessio…

      Breakout Webcast:

      https://jpmorgan.metameetings.net/events/healthcare19/sessio…



      https://finance.yahoo.com/news/array-biopharma-present-37th-…
      Avatar
      schrieb am 15.01.19 11:53:55
      Beitrag Nr. 102 ()
      Array BioPharma Announces 15.3 Months Median Overall Survival from the Safety Lead-in of the Phase 3 BEACON CRC Trial of the Combination BRAFTOVI®, MEKTOVI® and ERBITUX® in BRAF-Mutant Metastatic Colorectal Cancer

      - Data will be presented at ASCO 2019 Gastrointestinal Cancers Symposium -

      - Updated confirmed ORR remains 48% and updated median PFS remains 8.0 months -

      - Investor webcast will be held on Tuesday, January 15 at 9:00 AM ET -

      BOULDER, Colo., Jan. 14, 2019 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced updated safety and efficacy results, including mature overall survival (OS), from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of BRAFTOVI® (encorafenib), a BRAF inhibitor, MEKTOVI® (binimetinib), a MEK inhibitor and ERBITUX® (cetuximab), an anti-EGFR antibody, in patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC). The results showed that mature median OS was 15.3 months (95% CI, 9.6–not reached) for patients treated with the triplet.

      These data will be presented on Saturday, January 19 at the ASCO 2019 Gastrointestinal Cancers Symposium in San Francisco, California.
      Updated median progression-free survival (mPFS) and updated confirmed overall response rate (ORR) results for patients treated with the triplet in the safety lead-in remain the same, as previously reported, with 8 months mPFS (95% CI, 5.6-9.3) and a 48% ORR (95% CI, 29.4–67.5). Among the 17 patients who received only one prior line of therapy, the ORR was 62%.

      A BRAF mutation is present in up to 15% of all patients with mCRC and V600 is the most common BRAF mutation. [1-5] BRAFV600E-mutant mCRC patients have a mortality risk more than double that of mCRC patients without the mutation, and currently there are no U.S. Food and Drug Administration (FDA)-approved therapies specifically indicated for this high unmet need population. [3-10]

      "The mature median overall survival of 15.3 months demonstrated in the safety lead-in of the BEACON CRC trial is unprecedented in this patient population and, for context, represents a substantial improvement compared to the observed historical published benchmarks of approximately 4 to 6 months for median overall survival with current standards of care in patients with BRAF-mutant mCRC," said Axel Grothey, M.D., BEACON CRC trial lead investigator and Co-Chair of the National Cancer Institute's Gastrointestinal Cancer Steering Committee, West Cancer Center, Memphis, TN. "These updated data further underscore the potential of this triplet for patients with BRAF-mutant mCRC who are in desperate need of effective new treatment options."

      The triplet combination was generally well-tolerated with no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue (13%), anemia (10%), increased creatine phosphokinase (10%), increased aspartate aminotransferase (10%) and urinary tract infections (10%). The rate of grade 3 or 4 skin toxicities continued to be lower than generally observed with ERBITUX in mCRC.

      "We are delighted with the updated results from the BEACON CRC safety lead-in. Following consultations with the FDA and European Medicines Agency, we initiated an amendment to the BEACON CRC protocol to allow for an interim analysis based primarily on confirmed ORR and durability of response endpoints, which we believe could support an accelerated approval with positive results," said Victor Sandor, M.D., Chief Medical Officer, Array BioPharma.

      "We anticipate topline results from this interim analysis in the first half of this year. This timing allows for the subset of patients required for the interim analysis of ORR to achieve a response and for the durability of responses to be appropriately evaluated."

      https://finance.yahoo.com/news/array-biopharma-announces-15-…
      2 Antworten
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      schrieb am 15.01.19 11:55:54
      Beitrag Nr. 103 ()
      Antwort auf Beitrag Nr.: 59.633.642 von bernie55 am 15.01.19 11:53:55These data will be presented on Saturday, January 19 at the ASCO 2019 Gastrointestinal Cancers Symposium in San Francisco, California.

      BEACON CRC Safety Lead-In Data


      Title:

      Abstract #688: Updated results of the BEACON CRC safety lead-in: Encorafenib (ENCO) + binimetinib (BINI) + cetuximab (CETUX) for BRAFV600E-mutant metastatic colorectal cancer (mCRC)

      Presenter:

      Scott Kopetz, M.D., Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center

      Date:

      Saturday, January 19, 2019

      Times:

      7:00 - 7:55 a.m. and 12:15 - 1:45 p.m. Pacific Time

      Location:

      Poster N13; Moscone West Building
      Avatar
      schrieb am 15.01.19 15:41:03
      Beitrag Nr. 104 ()
      Antwort auf Beitrag Nr.: 59.633.642 von bernie55 am 15.01.19 11:53:55
      Zitat von bernie55: Array BioPharma Announces 15.3 Months Median Overall Survival from the Safety Lead-in of the Phase 3 BEACON CRC Trial of the Combination BRAFTOVI®, MEKTOVI® and ERBITUX® in BRAF-Mutant Metastatic Colorectal Cancer

      - Data will be presented at ASCO 2019 Gastrointestinal Cancers Symposium -

      - Updated confirmed ORR remains 48% and updated median PFS remains 8.0 months -

      - Investor webcast will be held on Tuesday, January 15 at 9:00 AM ET -











      Avatar
      schrieb am 30.01.19 10:55:44
      Beitrag Nr. 105 ()
      Array BioPharma to Report Financial Results for the Second Quarter of Fiscal 2019 on February 5, 2019

      Newswire•January 29, 2019

      BOULDER, Colo., Jan. 29, 2019 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) will report financial results for the second quarter of fiscal 2019 and hold a conference call to discuss those results on Tuesday, February 5, 2019. Ron Squarer, Chief Executive Officer, will lead the call.

      Date:
      Tuesday, February 5, 2019

      Time:
      9:00 a.m. Eastern Time

      https://finance.yahoo.com/news/array-biopharma-report-financ…
      1 Antwort
      Avatar
      schrieb am 05.02.19 14:09:38
      Beitrag Nr. 106 ()
      Antwort auf Beitrag Nr.: 59.743.191 von bernie55 am 30.01.19 10:55:44Array BioPharma Reports Financial Results for the Second Quarter of Fiscal 2019

      PR Newswire•February 5, 2019

      - Strong quarter for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in U.S. with $22.7 million in net product sales, which represents quarter over quarter growth of 62% -

      - Combination of BRAFTOVI, MEKTOVI and ERBITUX® (cetuximab) demonstrated 15.3 months median overall survival in safety lead-in of the Phase 3 BEACON CRC trial in BRAF-mutant metastatic colorectal cancer -

      - Cash, Cash Equivalents and Marketable Securities as of December 31, 2018 were $478 million -

      https://finance.yahoo.com/news/array-biopharma-reports-finan…
      Avatar
      schrieb am 22.02.19 15:10:25
      Beitrag Nr. 107 ()


      Array BioPharma to Present at the 8th Annual SVB Leerink Partners Global Healthcare Conference

      BOULDER, Colo., Feb. 21, 2019 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) today announced that its Chief Executive Officer, Ron Squarer, will speak at the SVB Leerink Partners 8th Annual Global Healthcare Conference in New York. The public is welcome to participate in the conference through a webcast on the Array BioPharma website.


      Event: SVB Leerink Partners 8th Annual Global Healthcare Conference

      Presenter: Ron Squarer, Chief Executive Officer, Array BioPharma

      Date: Thursday, February 28, 2019

      Time: 10:00 a.m. Eastern Time

      Webcast: http://wsw.com/webcast/leerink32/arry/


      A replay of the presentation will also be accessible under the "Investors/Investor Calendar" section of the website at www.arraybiopharma.com.

      https://www.prnewswire.com/news-releases/array-biopharma-to-…
      Avatar
      schrieb am 06.05.19 16:31:33
      Beitrag Nr. 108 ()
      Array BioPharma to Report Financial Results for the Third Quarter of Fiscal 2019 on May 7, 2019

      PR Newswire•April 30, 2019

      BOULDER, Colo., April 30, 2019 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) will report financial results for the third quarter of fiscal 2019 and hold a conference call to discuss those results on Tuesday, May 7, 2019 at 9:00 am ET.

      Date:
      Tuesday, May 7, 2019

      Time:
      9:00 a.m. Eastern Time


      https://finance.yahoo.com/news/array-biopharma-report-financ…
      1 Antwort
      Avatar
      schrieb am 07.05.19 15:26:24
      Beitrag Nr. 109 ()
      Antwort auf Beitrag Nr.: 60.497.664 von bernie55 am 06.05.19 16:31:33Fiscal 3Q Earnings Snapshot

      Associated Press•May 7, 2019

      BOULDER, Colo. (AP) _ Array BioPharma Inc. (ARRY) on Tuesday reported a loss of $37.5 million in its fiscal third quarter.

      On a per-share basis, the Boulder, Colorado-based company said it had a loss of 17 cents.

      The results exceeded Wall Street expectations. The average estimate of eight analysts surveyed by Zacks Investment Research was for a loss of 21 cents per share.:cool:


      The drug developer posted revenue of $64.7 million in the period, also beating Street forecasts. Six analysts surveyed by Zacks expected $51.5 million.:cool:

      Array BioPharma shares have increased 62% since the beginning of the year. The stock has risen 69% in the last 12 months.

      https://finance.yahoo.com/news/array-biopharma-fiscal-3q-ear…
      Avatar
      schrieb am 15.05.19 13:47:01
      Beitrag Nr. 110 ()
      Array BioPharma to Present at the Bank of America Merrill Lynch 2019 Healthcare Conference

      PR Newswire•May 9, 2019

      BOULDER, Colo., May 9, 2019 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced that its Chief Executive Officer, Ron Squarer, will speak at the Bank of America Merrill Lynch 2019 Health Care Conference in Las Vegas. The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

      Event:
      Bank of America Merrill Lynch 2019 Health Care Conference


      Presenter:

      Ron Squarer, Chief Executive Officer, Array BioPharma

      Date:
      Thursday, May 16, 2019

      Time:
      10:00 a.m. Pacific Time / 1:00 p.m. Eastern Time

      Webcast:

      http://www.veracast.com/webcasts/baml/healthcare2019/id83306…
      Avatar
      schrieb am 21.05.19 15:14:36
      Beitrag Nr. 111 ()
      Array BioPharma Announces BRAFTOVI + MEKTOVI + Cetuximab Meet Primary Endpoints of ORR and OS in Phase 3 BEACON CRC Trial Interim Analysis for the Treatment of BRAF(V600E)-mutant Metastatic Colorectal Cancer

      PR Newswire•May 21, 2019

      - BRAFTOVI combinations showed statistically significant improvement in ORR and OS versus control -

      - BRAFTOVI + MEKTOVI + cetuximab reduced the risk of death by 48% versus control -

      - Potential to be the first chemotherapy-free, targeted regimen for metastatic CRC patients -

      - Array intends to submit these data for marketing approval in 2H19 -

      - Array will host a conference call today, Tuesday, May 21, 2019, at 9:00 am

      https://finance.yahoo.com/news/array-biopharma-announces-bra…
      1 Antwort
      Avatar
      schrieb am 21.05.19 15:20:53
      Beitrag Nr. 112 ()
      Antwort auf Beitrag Nr.: 60.612.536 von bernie55 am 21.05.19 15:14:36> The study met both primary endpoints of objective response rate (ORR) and overall survival (OS) compared to Erbitux plus irinotecan-containing regimens (Control). Specifically, the ORR for the Triplet was 26.1% versus 1.9% for Control (p<0.0001) while median OS was 9.0 months compared to 5.4 months (p<0.0001).

      > The first "wrinkle" in the data appears to be the number of randomized patients used, 331 for ORR and 665 for OS. The company says future analyses will assess ORR on the total population and OS with longer follow-up.

      > Another interesting point is the performance of the combination of BRAFTOVI and Erbitux (BRAFTOVI Doublet), also showing statistically significant improvements in ORR and OS compared to Control (20.4% vs. 1.9% and 8.4 months vs. 5.4 months, respectively).

      > There was not a statistically significant separation between BRAFTOVI Triplet and BRAFTOVI Doublet, however.


      https://seekingalpha.com/news/3465641-array-bio-5-percent-pr…
      Avatar
      schrieb am 04.06.19 11:21:48
      Beitrag Nr. 113 ()
      Array BioPharma to Present at the Jefferies 2019 Global Healthcare Conference

      PR Newswire•May 29, 2019

      BOULDER, Colo., May 29, 2019 /PRNewswire/ -- Array BioPharma Inc. (ARRY) today announced that its Chief Executive Officer, Ron Squarer, will speak at the Jefferies 2019 Global Healthcare Conference in New York City. The public is welcome to participate in the conference through a webcast on the Array BioPharma website.

      Event:
      Jefferies 2019 Global Healthcare Conference

      Presenter:

      Ron Squarer, Chief Executive Officer, Array BioPharma

      Date:
      June 5, 2019

      Time:
      9:00 a.m. Eastern Time

      Webcast: http://wsw.com/webcast/jeff118/arry/" target="_blank" rel="nofollow ugc noopener">
      http://wsw.com/webcast/jeff118/arry/



      https://finance.yahoo.com/news/array-biopharma-present-jeffe…
      Avatar
      schrieb am 17.06.19 14:31:54
      Beitrag Nr. 114 ()
      Array BioPharma....ein Übernahmekandidat?


      :) :eek: Pfizer to Acquire Array BioPharma:eek: :)



      PR Newswire PR NewswireJune 17, 2019

      -Proposed acquisition strengthens Pfizer's innovative biopharmaceutical business and is expected to accelerate its growth trajectory particularly in the long term

      - Opportunity to strengthen category leadership in Oncology with the ad dition of a breakthrough combination of BRAF/MEK inhibitors under investigation for a potential first-in-class therapy for patients with BRAF-mutant metastatic colorectal cancer

      - Expands Pfizer's pipeline with multiple high-potential targeted investigational cancer therapies and adds a large portfolio of royalty-generating out-licensed medicines

      - Plans to maintain highly productive research unit in Boulder to complement Pfizer's research hubs

      - Transaction valued at :) $48 :) per Array share in cash, for a total enterprise value of approximately $11.4 billion

      https://finance.yahoo.com/news/pfizer-acquire-array-biopharm…
      Avatar
      schrieb am 17.06.19 14:52:23
      Beitrag Nr. 115 ()
      Wieder eines meiner Biotech - Longinvestment, das von einem BP übernommen wird. :cool: :)

      Zumindest ist die Übernahme von Pfizer eine klare Ansage - sprich ohne Geschnörkel und Zusatzbedingungen - es wird ein Buyout Price genannt und fertig. :)

      @cyberhexe
      Du hast noch `ne BOARDMAIL ;)
      3 Antworten
      Avatar
      schrieb am 17.06.19 17:01:00
      Beitrag Nr. 116 ()
      Antwort auf Beitrag Nr.: 60.823.787 von bernie55 am 17.06.19 14:52:23Hi Bernie...good day! Das Warten hat sich nun doch fürstlich bezahlt gemacht. ;)
      Werde dir bei Gelegenheit antworten.
      2 Antworten
      Avatar
      schrieb am 17.06.19 22:33:10
      Beitrag Nr. 117 ()
      Antwort auf Beitrag Nr.: 60.824.957 von Cyberhexe am 17.06.19 17:01:00Hi Bernie...good day! Das Warten hat sich nun doch fürstlich bezahlt gemacht.

      YEPP..wie wahr...and what a grrreeeeaaaat feeling..

      Avatar
      schrieb am 17.06.19 22:35:37
      Beitrag Nr. 118 ()
      Antwort auf Beitrag Nr.: 60.824.957 von Cyberhexe am 17.06.19 17:01:00Werde dir bei Gelegenheit antworten.

      Just do it , but no hurry....:cool: ;)
      Avatar
      schrieb am 02.07.19 15:24:30
      Beitrag Nr. 119 ()
      Array pushed Pfizer for a higher price to get deal done
      Jonathan Gardner
      July 1, 2019


      - Array BioPharma's board rejected an initial $44-per-share buyout offer Pfizer made on May 29, saying it was too low for Array to commit to the June 17 announcement timeline that Pfizer sought, a regulatory notice filed Friday by the biotech showed.

      - Pfizer's final knockout offer of $48 a share was contingent on the June 17 announcement date and Array not seeking any additional offers.

      Array is the third public targeted oncology company to be acquired in the last seven months for which only one serious bidder emerged. The others were Tesaro and Loxo Oncology, bought by GlaxoSmithKline and Eli Lilly, respectively.

      https://www.biopharmadive.com/news/array-pushed-pfizer-for-a…
      Array Biopharma | 41,04 €
      Avatar
      schrieb am 05.07.19 22:43:14
      Beitrag Nr. 120 ()
      und nehmt ihr an?
      Array Biopharma | 41,76 €
      2 Antworten
      Avatar
      schrieb am 10.07.19 11:03:55
      Beitrag Nr. 121 ()
      Antwort auf Beitrag Nr.: 60.965.698 von xylophon am 05.07.19 22:43:14
      Zitat von xylophon: und nehmt ihr an?



      Hi xylophon,

      im Prinzip hast du ( nur) zwei Möglichkeiten -
      entweder jetzt deinen Aktienbestand zu aktuellen Kursen zu verkaufen ( dann wohl etwas unter dem Übernahmepreis von 48 USD) oder darauf zu warten, dass im Laufe der zweiten Jahreshälfte der Abschluss der Übernahme verkündet wird und dir dann der Übernahmepreis von 48 USD ( zum aktuellen USD/ EUR Kurs) auf dein Depotkonto gutgeschrieben wird.

      Grüße
      bernie55 :)
      Array Biopharma | 40,96 €
      1 Antwort
      Avatar
      schrieb am 10.07.19 20:26:00
      Beitrag Nr. 122 ()
      Antwort auf Beitrag Nr.: 60.993.395 von bernie55 am 10.07.19 11:03:55ja? Ich hatte gar nicht gelesen, dass man gar keine Wahl hat, das habe ich auch bei Doubleclick erlebt. Grds würde ich dann eher jetzt verkaufen, denn das Geld habe ich dann schon und kann es neu anlegen.
      Array Biopharma | 46,72 $
      Avatar
      schrieb am 16.07.19 07:03:10
      Beitrag Nr. 123 ()
      Macht es eigentlich einen steuerlichen Unterschied ob ich jetzt aktiv verkaufe oder warte bis mir die 48$/Aktie gutgeschrieben werden?
      Array Biopharma | 46,42 $
      2 Antworten
      Avatar
      schrieb am 16.07.19 15:40:33
      Beitrag Nr. 124 ()
      Antwort auf Beitrag Nr.: 61.032.550 von _fou_ am 16.07.19 07:03:10@_fou_

      Die Besteuerung des Gewinns durch den jetzigen Verkauf deiner Aktien bzw. durch die Einbuchung des Betrages ( inkl. Gewinn) nach Übernahme wird in der gleichen Höhe besteuert werden – also Kapitalertragsteuer 25 Prozent zzgl. Soli von 5,5 Prozent und ggf. Kirchensteuer von 8 Prozent bis 9 Prozent

      Die USA Quellensteuer wird aufgrund section 132 ( siehe unten) nicht einbehalten.

      Frage aber sicherheitshalber noch einmal bei deiner Depotbank nach.

      Grüße
      bernie55:)





      Quelle: Kapitalmaßnahmen: Steuerliche Bewertung und Einstufung, ISBN 3658069767
      ( Info von Spoekenkieker2 schrieb am 04.02.17 11:24:52 Beitrag Nr. 23.998 ( 54.238.192 )
      Array Biopharma | 41,23 €
      1 Antwort
      Avatar
      schrieb am 16.07.19 15:52:51
      Beitrag Nr. 125 ()
      Vielen Dank für die Erläuterung :)
      Array Biopharma | 46,51 $
      Avatar
      schrieb am 17.07.19 22:37:31
      Beitrag Nr. 126 ()
      Antwort auf Beitrag Nr.: 61.036.939 von bernie55 am 16.07.19 15:40:33Danke für die Info, ich habe aber lieber jetzt verkauft, wobei der Text nur ein zusätzlicher Grund war.
      comdirect wies auf die Möglichkeit hin und ich habe mit der Steuer schon sehr komische Erfahrungen gemacht, etwa bei der Abspaltung von Paypal von ebay, was als eine Art "Dividende" bewertet wurde, was natürlich abwegig ist. Trotzdem war auf einmal das Konto im Minus, weil ganz viel Steuern fällig wurden und ich habe bis heute keinen Cent davon wiedergesehen, weil die Bank ans Finanzamt verwiesen hat und dort hat man wohl auf irgendwelche Musterprozesse gewartet. Ob die zu Ende sind??
      Array Biopharma | 41,21 €


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