Purple Biotech (PPBT) ehemals KTOV (Mkap $16 M) ( Cash $17 M) US Zulassungsantrag diesen Quartal (Seite 180)
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Kitov Announces Results of Study Demonstrating NT-219 Enhanced Efficacy of Keytruda® in Immune-Oncology Preclinical Model
TEL AVIV, Israel, July 18, 2017 /PRNewswire/ -- Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV) (TASE: KTOV), an innovative biopharmaceutical company, today announced results of a pre-clinical study demonstrating that NT-219, the lead drug candidate of its subsidiary TyrNovo Ltd., in combination with Keytruda®, converted non-responding tumors to responders and blocked tumor progression in an immune-oncology preclinical model.
The study, conducted in collaboration with researchers at Bar Ilan University and Rabin Medical Center, assessed NT-219's ability to overcome cancer drug resistance in a patient-derived xenograft (PDX) model of immune-deficient mice, in which a tumor originated from an esophagus cancer biopsy was implanted. The mice were supplemented with immune cells from the same patient (double autologous). While no response was observed with Keytruda® alone or with NT-219 alone, and the tumors aggressively progressed, mice treated concomitantly with a combination of Keytruda® and NT-219 demonstrated complete blockage of tumor progression.
"We are excited with these initial results obtained with NT-219 in combination with pembrolizumab (Keytruda®)," stated Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer. "Previous results obtained with NT-219 demonstrated its efficacy in overcoming drug resistance in a variety of cancers and in combination with various pharmacologic cancer therapies. We are focused on advancing this highly promising therapeutic candidate to clinical trials as quickly as possible in order to provide enhanced treatment options to cancer patients."
About TyrNovo
TyrNovo Ltd., a Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) company, is developer of novel small molecules in the oncology therapeutic field. TyrNovo is developing NT-219, an oncology product designed to be used in combination with other oncology drugs. NT-219 is a small molecule that presents a new concept in cancer therapy. In combination with various approved oncology drugs, NT-219 has demonstrated potent anti-tumor effects and increased survival in various cancer models, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers. Its mechanism of action is through the prevention of acquired resistance in tumors and by regression of resistant tumors. For more information on TyrNovo please visit http://www.tyrnovopharma.com.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov's flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial, and its New Drug Application for the U.S. Food and Drug Administration is currently being prepared for submission. By lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.
Forward-Looking Statements and Kitov's Safe Harbor Statement
Certain statements in this press release are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the lack of sufficient funding to finance the clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference or infringement action; our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions; the uncertainty surrounding an investigation by the Israel Securities Authority into our historical public disclosures and the potential impact of such investigation on the trading of our securities or on our clinical, commercial and other business relationships, or on receiving the regulatory approvals necessary in order to commercialize our products, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the U.S. Securities and Exchange Commission (the "SEC") , including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement, or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, http://www.sec.gov.
For further information, contact:
Simcha Rock
Chief Financial Officer of Kitov and Director of TyrNovo
+972-3-933-3121 ext. #105
simcha@kitovpharma.com
Bob Yedid
Managing Director
LifeSci Advisors, LLC
646-597-6989
bob@lifesciadvisors.com
SOURCE Kitov Pharmaceuticals Holdings Ltd.
TEL AVIV, Israel, July 18, 2017 /PRNewswire/ -- Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV) (TASE: KTOV), an innovative biopharmaceutical company, today announced results of a pre-clinical study demonstrating that NT-219, the lead drug candidate of its subsidiary TyrNovo Ltd., in combination with Keytruda®, converted non-responding tumors to responders and blocked tumor progression in an immune-oncology preclinical model.
The study, conducted in collaboration with researchers at Bar Ilan University and Rabin Medical Center, assessed NT-219's ability to overcome cancer drug resistance in a patient-derived xenograft (PDX) model of immune-deficient mice, in which a tumor originated from an esophagus cancer biopsy was implanted. The mice were supplemented with immune cells from the same patient (double autologous). While no response was observed with Keytruda® alone or with NT-219 alone, and the tumors aggressively progressed, mice treated concomitantly with a combination of Keytruda® and NT-219 demonstrated complete blockage of tumor progression.
"We are excited with these initial results obtained with NT-219 in combination with pembrolizumab (Keytruda®)," stated Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer. "Previous results obtained with NT-219 demonstrated its efficacy in overcoming drug resistance in a variety of cancers and in combination with various pharmacologic cancer therapies. We are focused on advancing this highly promising therapeutic candidate to clinical trials as quickly as possible in order to provide enhanced treatment options to cancer patients."
About TyrNovo
TyrNovo Ltd., a Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) company, is developer of novel small molecules in the oncology therapeutic field. TyrNovo is developing NT-219, an oncology product designed to be used in combination with other oncology drugs. NT-219 is a small molecule that presents a new concept in cancer therapy. In combination with various approved oncology drugs, NT-219 has demonstrated potent anti-tumor effects and increased survival in various cancer models, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers. Its mechanism of action is through the prevention of acquired resistance in tumors and by regression of resistant tumors. For more information on TyrNovo please visit http://www.tyrnovopharma.com.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov's flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the primary efficacy endpoint for its Phase III clinical trial, and its New Drug Application for the U.S. Food and Drug Administration is currently being prepared for submission. By lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.
Forward-Looking Statements and Kitov's Safe Harbor Statement
Certain statements in this press release are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the lack of sufficient funding to finance the clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference or infringement action; our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions; the uncertainty surrounding an investigation by the Israel Securities Authority into our historical public disclosures and the potential impact of such investigation on the trading of our securities or on our clinical, commercial and other business relationships, or on receiving the regulatory approvals necessary in order to commercialize our products, and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the U.S. Securities and Exchange Commission (the "SEC") , including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement, or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC's website, http://www.sec.gov.
For further information, contact:
Simcha Rock
Chief Financial Officer of Kitov and Director of TyrNovo
+972-3-933-3121 ext. #105
simcha@kitovpharma.com
Bob Yedid
Managing Director
LifeSci Advisors, LLC
646-597-6989
bob@lifesciadvisors.com
SOURCE Kitov Pharmaceuticals Holdings Ltd.
hab heute bei 1,60 USD noch paar bekommen, dann ist mir der Kurs weggelaufen
kommt jetzt endlich schwung rein wenn wir glück haben könnten wir sehr schnell die $3
Hier sind noch ein paar Infos zu KTOV ,, wie gesagt die Aktie sollte man wirklich nur als Zock betrachten und beim hoffentlich nächsten Pump einfach verkaufen hab die Aktie nur vorgestellt weil die ausgangslage gut ist Aktie notiert auf cashniveau und nahe allzeittief .
Kitov Announces License Agreement for KIT-302 in South Korea
https://finance.yahoo.com/news/kitov-announces-license-agree…
https://seekingalpha.com/article/3939596-kitov-pharmaceutica…
Conclusion:In my original article, I ballparked KTOV's valuation at $22.50 per share. That valuation assumed KTOV took KIT-302 to market on its own and therefore, included additional equity financings and a concomitant higher share count on which to base the per share price. It also assumed a weaker marketing capability and therefore, lower peak sales. In this article, I've estimated KTOV's valuation on the idea that it sells KIT-302 to a large pharmaceutical company and I've provided some comparables to ground this valuation. (Nonetheless, there are a lot of assumptions here, particularly the peak sales numbers and the DCF inputs.) The comparable valuation method gives a share price target range of $13 to $29 per share, which corroborates the initial $22.50 per share target. As a result, I continue to hold KTOV as one of my favorite longs, and am hoping for a big payoff within the next four years or so. Indeed, after performing this research, I think it's likely that one of the companies mentioned in the article will buy KTOV sooner rather than later - with Pfizer (Celebrex's developer) being my front-running candidate.
Kitov Announces License Agreement for KIT-302 in South Korea
https://finance.yahoo.com/news/kitov-announces-license-agree…
https://seekingalpha.com/article/3939596-kitov-pharmaceutica…
Conclusion:In my original article, I ballparked KTOV's valuation at $22.50 per share. That valuation assumed KTOV took KIT-302 to market on its own and therefore, included additional equity financings and a concomitant higher share count on which to base the per share price. It also assumed a weaker marketing capability and therefore, lower peak sales. In this article, I've estimated KTOV's valuation on the idea that it sells KIT-302 to a large pharmaceutical company and I've provided some comparables to ground this valuation. (Nonetheless, there are a lot of assumptions here, particularly the peak sales numbers and the DCF inputs.) The comparable valuation method gives a share price target range of $13 to $29 per share, which corroborates the initial $22.50 per share target. As a result, I continue to hold KTOV as one of my favorite longs, and am hoping for a big payoff within the next four years or so. Indeed, after performing this research, I think it's likely that one of the companies mentioned in the article will buy KTOV sooner rather than later - with Pfizer (Celebrex's developer) being my front-running candidate.
Antwort auf Beitrag Nr.: 55.348.475 von Biohero am 18.07.17 17:14:19KTOV is wirklich ein Zock das sich extrem lohnen könnte ....
Here's What's Going To Move Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) Over The Next Twelve Months....July 11, 2017
https://insiderfinancial.com/here-are-the-key-timeframes-for…
What is important is that the NDA is being submitted in batches electronically by way of a third party submission platform and, as per management’s latest announcement (June 26) is set to complete (as in, the submission will finalize) during the third quarter of this year. Once the submission is finalized and accepted by the FDA (which, with any luck, should also come during the third quarter this year) we will get a PDUFA date for the drug in question. With a PDUFA date in place, markets can get some idea of when this drug will be hitting the shelves.
In development stage biotechnology, where capital burn is incredibly important to the near to medium term risk side of the equation, solid time frames (and especially as relates to time-to-revenue-generation) are key to forming a bias. With such a timeframe in place (as outlined by the PDUFA) we think this company will start to attract a large base of speculative volume and – in turn – will start to appreciate in value as KIT-302 advances towards FDA decision day.
The submission in question is supported by some strong phase III data as relates to efficacy and safety in the target indication (the above-mentioned pain caused by osteoarthritis and hypertension) meaning that the drug has a fairly good chance of picking up approval on the back of its current application. This is development stage biotechnology, of course, so nothing is guaranteed, but in our opinion, the chances of a regulatory green light look good.
Here's What's Going To Move Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) Over The Next Twelve Months....July 11, 2017
https://insiderfinancial.com/here-are-the-key-timeframes-for…
What is important is that the NDA is being submitted in batches electronically by way of a third party submission platform and, as per management’s latest announcement (June 26) is set to complete (as in, the submission will finalize) during the third quarter of this year. Once the submission is finalized and accepted by the FDA (which, with any luck, should also come during the third quarter this year) we will get a PDUFA date for the drug in question. With a PDUFA date in place, markets can get some idea of when this drug will be hitting the shelves.
In development stage biotechnology, where capital burn is incredibly important to the near to medium term risk side of the equation, solid time frames (and especially as relates to time-to-revenue-generation) are key to forming a bias. With such a timeframe in place (as outlined by the PDUFA) we think this company will start to attract a large base of speculative volume and – in turn – will start to appreciate in value as KIT-302 advances towards FDA decision day.
The submission in question is supported by some strong phase III data as relates to efficacy and safety in the target indication (the above-mentioned pain caused by osteoarthritis and hypertension) meaning that the drug has a fairly good chance of picking up approval on the back of its current application. This is development stage biotechnology, of course, so nothing is guaranteed, but in our opinion, the chances of a regulatory green light look good.
Trading Spotlight
Was soll ich sagen die Aktie notiert nahe Allzeittief und auf Cash niveau und in diesem Quartal soll die US Zulassung für KIT-302 (Behandlung für Osteoarthritis-Schmerzen sowie gleichzeitig für Bluthochdruck) beantragt werden . Ich fasse es kurz zusammen : low float aktie ,nasdaq wert ,extrem niedrig bewertet ,US Zulassungsantrag für ein attraktives Produkt diesen Quartal und es werden Partnergespräche für die auslizenzierung geführt die Aktie könnte der RIESENZOCK mit enorm Gewinnchancen für die nächsten monate werden .Wenn sie die Zulassung diesen Quartal beantragen dürfte das jede menge neue Anleger anlocken besonders wegen der übelst niedrigen Marktkapitalisierung .Die üblichen Risiken und Nebenwirkungen mit Biotechs sollte ja inzwischen jedem bekannt sein .GL
Kitov Pharma (KTOV)
Marktkap: $16 Million
Cash $17 Million (inkl KE von letzter Woche)
Kurs: $1.44
Shares Out: 10.6 Million
Juni Präsentation
http://kitovpharma.investorroom.com/download/KitovPresentati…
KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously
Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial
Marketing potential Pipeline candidates address large, multi-billion dollar markets
Kitov Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension
https://baystreet.ca/articles/research_reports/lifesci/Kitov…
Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.
Kitov Updates on KIT-302 New Drug Application
http://kitovpharma.investorroom.com/news-releases?item=50
Kitov expects that the formal filing of the NDA by the FDA will occur by the end of the third quarter of 2017.
Kitov Received a $2 Million Filing Waiver from FDA
http://kitovpharma.investorroom.com/news-releases?item=46
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for KIT-302. KIT-302 is Kitov's patented combination of Amlodipine Besylate-Celecoxib tablets, intended to treat osteoarthritis pain and hypertension simultaneously.
Kitov Pharma (KTOV)
Marktkap: $16 Million
Cash $17 Million (inkl KE von letzter Woche)
Kurs: $1.44
Shares Out: 10.6 Million
Juni Präsentation
http://kitovpharma.investorroom.com/download/KitovPresentati…
KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously
Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial
Marketing potential Pipeline candidates address large, multi-billion dollar markets
Kitov Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension
https://baystreet.ca/articles/research_reports/lifesci/Kitov…
Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.
Kitov Updates on KIT-302 New Drug Application
http://kitovpharma.investorroom.com/news-releases?item=50
Kitov expects that the formal filing of the NDA by the FDA will occur by the end of the third quarter of 2017.
Kitov Received a $2 Million Filing Waiver from FDA
http://kitovpharma.investorroom.com/news-releases?item=46
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for KIT-302. KIT-302 is Kitov's patented combination of Amlodipine Besylate-Celecoxib tablets, intended to treat osteoarthritis pain and hypertension simultaneously.
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