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CTXR - Citius Pharmaceuticals - Gute Pipeline plus Corona Phantasie

eröffnet am 15.05.20 17:03:19 von
neuester Beitrag 12.09.21 10:50:19 von

ISIN: US17322U2078 | WKN: A2DXS0 | Symbol: CTXR
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12.09.21 10:50:19
Beitrag Nr. 130 ()
Warum dieser Citius-Analyst der Ansicht ist, dass die Aktien von Biopharma 375 % Aufwärtspotenzial bieten
Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) gab Anfang dieser Woche eine Vereinbarung mit Dr.
Benzinga
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10.09.2021, 16:21:14 Uhr
Haftungsausschluss: Dieser Artikel stellt nur die persönliche Meinung des Autors dar und stellt keine ...
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Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) gab Anfang dieser Woche eine Vereinbarung mit Dr. Reddy's Laboratories Ltd (NYSE:RDY) zum Erwerb seiner exklusiven Lizenz von E7777 bekannt, einer onkologischen Immuntherapie im Spätstadium zur Behandlung des kutanen T-Zell-Lymphoms , eine seltene Form des Non-Hodgkin-Lymphoms.

Der Citius-Analyst: Jason Kolbert, Analyst von Dawson James Securities, behielt ein Kaufrating für die Citius-Aktie bei und erhöhte das Kursziel von 8 auf 10 US-Dollar.

Die Citius-These: E7777, deren Übernahme Citius zugestimmt hat, wurde kürzlich in Japan zugelassen und verfolgt in den USA einen ähnlichen Weg, sagte Analyst Kolbert in einer Mitteilung.

E7777 ist eine verbesserte Formulierung des onkologischen Wirkstoffs ONTAK, der zuvor von der Food and Drug Administration für die Behandlung von Patienten mit persistierendem oder rezidivierendem CTCL zugelassen wurde, stellte der Analyst fest.

Verwandter Link: Der tägliche Biotech-Puls: Apellis sinkt bei Daten, Endo glänzt bei der Beilegung von Opioid-Rechtsstreitigkeiten, T2 Biosystems steigt bei der Mutantenerkennungsfähigkeit des COVID-Tests

Die aktuelle Phase-3-Studie in den USA ist dem Analysten zufolge eine Brückenstudie zur Validierung einer Herstellungsänderung, Dosisbestätigung und Wirksamkeit bei CTCL-Patienten. Angesichts der Tatsache, dass der Prüfgegenstand eine verwaiste Indikation aufweist, ist die Preisgestaltung wahrscheinlich zu hoch, sagte der Analyst.

Der letzte Patient in eine zulassungsrelevante Studie mit E7777 wurde aufgenommen und ein Zulassungsantrag für Biologika für die erste Indikation bei CTCL wird voraussichtlich bis Ende 2022 bei der FDA eingereicht, sagte Kolbert.

Citius zahlte 40 Millionen US-Dollar im Voraus und hat eine Verpflichtung für Meilensteine ​​in Höhe von 40 Millionen US-Dollar und möglicherweise eine Lizenzgebühr von 10 %, schätzt der Analyst. Zusätzliche Zahlungen für andere Indikationen und bescheidene Gebühren an Eisai Co., Ltd. (OTC: ESALY) seien fällig, fügte er hinzu.

ET7777 hat eine jährliche Chance von 100 bis 200 Millionen US-Dollar, sagte der Analyst. Der Analyst sieht auch Synergien, da die Zielgruppe von MinoLok Patienten mit Dauerkathetern sind und ein bedeutendes Segment dieses Marktes Onkologiepatienten sind.

"Klinische Daten von E7777 deuten auf eine ORR (Overall Response Rate) von 40% hin, und die Aufsichtsbehörden glauben, dass dies die Zulassung unterstützt, insbesondere in Verbindung mit einem gutartigen Nebenwirkungsprofil im Vergleich zu anderen verwendeten Wirkstoffen (Off-Label)," sagte Dawson James.

Citius Price Action: Am Freitagmorgen fielen die Citius-Aktien um 0,64% auf 2,09 USD.
Citius Pharmaceuticals | 1,770 €
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10.09.21 11:23:48
Beitrag Nr. 129 ()
Citius Pharmaceuticals to Present at the H.C. Wainwright 23rd Annual Global Investment Conference September 13-15
Wed, September 8, 2021, 8:15 PM
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Citius to highlight addition of Phase 3 cancer immunotherapy to its late-stage pipeline

CRANFORD, N.J., Sept. 8, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products and stem cell therapies, today announced that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021.

The presentation video will be available for viewing on demand starting at 7:00 am ET on Monday, September 13th. Investors may register for the conference at the event website. The archived webcast will be available for 90 days after the event and will be accessible on the Citius website.

Myron Holubiak, President and Chief Executive Officer of Citius, and Dr. Myron Czuczman, Chief Medical Officer of Citius, will discuss the Company's expanded pipeline and near-term catalysts
Citius Pharmaceuticals | 1,790 €
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10.09.21 11:22:17
Beitrag Nr. 128 ()
Citius (CTXR) Acquires Dr. Reddy's License for NHL Therapy
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Wed, September 8, 2021, 10:34 PM
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Citius Pharmaceuticals, Inc. CTXR announced that it has acquired the exclusive in-license rights of Dr. Reddy’s Laboratories RDY for E7777 (denileukin diftitox). The candidate is an improved formulation of Ontak, which received FDA approval for the treatment of persistent or recurrent cutaneous T-cell lymphoma (“CTCL”), a rare form of non-Hodgkin lymphoma (“NHL”).

Please note that Dr. Reddy’s had previously acquired global license rights (excluding Japan and Asia) from Eisai Co. ESALY to develop and commercialize E7777. The rights for Japan and Asia remain with Eisai.

Shares of Citius have rallied 107.8% so far this year against the industry’s 9.6% decline.

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Per the agreement terms, Dr. Reddy’s will receive an upfront payment of $40 million and is entitled to receive up to $40 million and $70 million in development milestones for CTCL and additional indications, respectively. In addition, Eisai is eligible to receive a $6 million development milestone payment upon initial approval and additional commercial milestone payments related to the achievement of net product sales thresholds.

The drug, which is currently being evaluated in a pivotal phase III study to treat persistent or recurrent CTCL, has completed patient enrolment in the study. Top-line data from this study is anticipated in the first half of 2022.

While Eisai will be responsible for completing the current CTCL study, Citius will be responsible for development costs associated with potential additional indications. The company expects to file a biologics license application for the drug to treat CTCL by 2022-end.

We inform investors that Ontak was marketed in the United States from 2008 until it was voluntarily withdrawn from the market in 2014 to enable manufacturing improvements.

The company is also planning to evaluate the drug in patients with peripheral T-cell lymphoma, another form of NHL, and other cancer indications.

Apart from E7777, Citius is also evaluating its lead pipeline candidate Mino-Lok in a pivotal phase III study for the treatment of patients with catheter-related bloodstream infections (“CRBSIs”). Mino-Lok has received Fast Track designation from the FDA for CRBSIs.
Citius Pharmaceuticals | 1,790 €
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10.08.21 19:30:39
Beitrag Nr. 127 ()
Benzinga
Citius Pharmaceuticals Addresses Unmet Needs for Patients with CVCs

CTXR
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Emily Cervone
Wed, August 4, 2021, 9:34 PM
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What happens when the one product keeping you alive becomes infected?

Central venous catheters (CVCs) are important life lines for treating many patients, including those with cancer, coagulopathy, hemodialysis, and even those in intensive care units. These CVCs deliver vital fluids, blood, nutrition, medication, and hemodynamic therapies to critically ill patients. However, these devices, unfortunately, pose a significant risk of device-related infections, negating their very purpose which is to keep patients alive and well.

Almost 7% of patients receiving the 7 million CVCs used annually develop catheter-related bloodstream infections (CRBSIs), putting patients with infected CVCs at a higher risk of morbidity and mortality. The current solution to this problem? Removing the CVC, replacing it with a new one, and having to choose a new access port in the meantime. This process is costly, difficult, and sometimes even dangerous, with a complication rate of about 15% to 20%.

One company has set out to find a better way to address these infections: Citius Pharmaceuticals (NASDAQ: CTXR). Thanks to its new antibiotic lock therapy Mino-Lok®, patients may soon have a new solution for salvaging infected catheters.

Mino-Lok contains minocycline, EDTA, and ethyl alcohol, all of which combine to break down bacterial biofilms that form inside a CVC. Essentially, it cleans the catheter, allowing it to remain in use and saved from having to be removed from the patient. A Phase 2b trial proved to be a success: The product saved 100% of the infected CVCs with zero side effects, compared to the 18% adverse effect rate seen in the cohort where patients had their infected CVC removed and replaced.

Recently, an interim review of data in the company’s Phase 3 trial by an independent Data Monitoring Committee resulted in a recommendation to continue the trial with no modifications. In addition, thanks to receiving the Qualified Infectious Disease Product designation, Mino-Lock qualifies for additional incentives such as "Fast Track" Designation, Priority Review for development, and five years of market exclusivity if approved. Mino-Lock has the potential to be the first and only FDA-approved product to salvage infected CVCs.

The plan is to file a New Drug Application in 2022, following the anticipated completion of the Phase 3 trial, which is more than 80% enrolled. With $103.7 million in cash, there is plenty of cushion to complete the trial and plan for commercial launch of the product which could potentially save countless lives. Not to mention, the current trial is partnered with a leading cancer center, and is supported by leaders in the medical field.

Citius Pharmaceuticals has a dedicated management team with a sustained record of accomplishments in the commercialization of pharmaceutical products, and we expect Mino-Lock will be no exception. Other products in their pipeline include an induced mesenchymal stem cell therapy being developed for the treatment of acute respiratory distress syndrome (ARDS), often associated with COVID-19, Halo-Lido (CITI-002), potentially the first and only FDA-approved prescription product for the treatment of hemorrhoids, and Mino-Wrap (CITI-101), a bio-absorbable film used for reducing inflammation post-mastectomy and breast reconstruction surgery.

With the belief that its work is filling a gap in current unmet medical needs, Citius Pharmaceuticals' forward-thinking products look to make a real difference in the lives of many.
Citius Pharmaceuticals | 1,874 $
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08.07.21 04:16:18
Beitrag Nr. 126 ()
Citius Pharmaceuticals, Inc. Provides First Half 2021 Business Update, Highlights Upcoming Milestones
Wed, July 7, 2021, 8:20 PM

CTXR
+3.24%
- Phase 3 Mino-Lok® trial proceeding as planned following recommendation by independent Data Monitoring Committee (DMC), highlighting important safety and efficacy signals -

- Mino-Lok® New Drug Application (NDA) submission planned for 2022 following anticipated completion of Phase 3 trial by the end of 2021 or early 2022 -

- Citius financial flexibility expanded with $127.6 million in financing activities during the first half of 2021, including $16.9 million in cash proceeds from warrants exercised during the quarter ended June 30, 2021 -

CRANFORD, N.J., July 7, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today provided a business update for the six-month period ended June 30, 2021 and reported on recent corporate developments.

Recent Highlights and Upcoming Milestones

On July 1, 2021, Citius reported that the independent DMC recommended continuation of the Phase 3 Mino-Lok® pivotal superiority trial as planned with no modifications or safety concerns,

Citius expects to complete the Mino-Lok® trial by the end of 2021 or early 2022, subject to continued easing of COVID-19 restrictions in the U.S.,

Citius plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2022 following completion of its Phase 3 Mino-Lok® trial, and

Subsequent to March 31, 2021, Citius issued 11.2 million shares of Citius common stock upon the exercise of warrants, for aggregate proceeds of $16.9 million during the quarter and a total of $127.6 million in financing activities during the first half of 2021.

"On July 1, 2021, we reported that the independent Data Monitoring Committee (DMC), following its third interim review, recommended continuing the Phase 3 trial for Mino-Lok® without modification. This recommendation affirms that there is an important efficacy signal that merits moving forward with the trial, there are no safety concerns to warrant halting the trial, and that the full data set upon trial completion may support statistically significant superiority. Whether Mino-Lok® demonstrates statistical superiority will only be known to us once the trial is finished and the data is unblinded. We view the recommendation of the DMC as a strong positive signal, and remain fully committed to completing the trial in a timely manner," stated Myron Holubiak, President and Chief Executive Officer of Citius.

"Mino-Lok® trial patients represent an extremely ill population, which is challenging to enroll under the best of circumstances. Like many clinical trials conducted during the pandemic, the timeline for our study has been impacted by COVID-19. It has taken longer than anticipated to enroll patients due to restrictions established at our trial sites during the height of the pandemic. These restrictions, in place for close to half of the duration of our trial, reflect a series of challenges including: site closures, limited site and patient access, reallocation of resources away from clinical trials to COVID-patient treatment, modifications to catheter infection treatment protocols, and lengthy approval time to qualify new study sites, resulting in fewer monthly patient screenings compared to pre-pandemic levels. The ability of sites to ramp back up for the Mino-Lok® trial depends largely on how these varied and complex factors are addressed. Several institutions have resumed our trial, and provided that COVID restrictions continue to ease and are not reinstated, we believe it would be possible for our trial sites to complete enrollment in the Mino-Lok® study as early as the end of the year. That would put us on target to submit an NDA in 2022," added Mr. Holubiak.

"We intend to aggressively pursue all options to expedite completion of the Mino-Lok® trial. During the first half of 2021, we raised more than $127 million, of which approximately $17 million was from warrants exercised since March 31, 2021. We intend to leverage these resources to accelerate our outreach efforts to advance the trial. Moreover, we believe we are well capitalized to advance Mino-Lok® beyond trial completion, and will engage closely with the FDA in the coming months to do so. Concurrently, we are actively advancing three additional first-and-only or novel pipeline products as outlined in our updated corporate presentation published on our website this morning. With a late-stage product candidate moving toward completion of its Phase 3 trial, depth in our pipeline, and the financial resources to execute our near-term strategy, we believe Citius is better positioned than ever before to deliver long-term value to shareholders," concluded Mr. Holubiak
Citius Pharmaceuticals | 2,230 $
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07.07.21 19:32:42
Beitrag Nr. 125 ()
Antwort auf Beitrag Nr.: 68.670.649 von Panto89 am 02.07.21 09:42:01Ich fürchte das wird länger dauern. Prognose geht bis nach 2020 rein. Dann erst folgt der Zulassungsantrag für mino-lock. Und mino-lock ist noch nicht der burner. Trotz dem wäre es gut gewesen wenn schon mal 1 Produkt auf dem Markt ist. Wieder ein halbes Jahr warten birgt auch wieder neue Unwegsamkeiten (Korona, Finanzierung,...)

https://www.sec.gov/Archives/edgar/data/1506251/000121390021…

https://www.sec.gov/Archives/edgar/data/1506251/000121390021…

Ich habe meine Gewinne erstmal realisiert. Die Aktie landet wieder in der watch list.

Euch allen viel Glück
Citius Pharmaceuticals | 2,205 $
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02.07.21 09:42:01
Beitrag Nr. 124 ()
Ein vorzeitiger Abbruch hätte eine frühere Markteinführung bedeutet. Nun müssen wir uns noch bis Nov / Dez gedulden. Darauf hatten wohl viele Leute keine Lust. So einen harten Abverkauf hätte ich trotzdem nicht erwartet, da keine bad news vorhanden sind
Citius Pharmaceuticals | 2,020 €
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02.07.21 09:24:51
Beitrag Nr. 123 ()
Antwort auf Beitrag Nr.: 68.668.840 von ooy am 02.07.21 05:08:38
Zitat von ooy: Herrliche Kaufgelegenheit fuer Leute, die den Zug verpasst hatten, nur meine Meinung...


genau, habe gestern auch nochmals nochglegt.
Nervt halt wenn man sieht dass sie vor einigen Tagen >4$ war und die News ja eigentlich sehr gut sind.

Sehe es aber wie iknowtheway, dass da einige mit einem frühzeitigen Abbruch durch das DMC (wegen Überlegenheit?) gerechnet haben.
Citius Pharmaceuticals | 2,060 €
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02.07.21 05:08:38
Beitrag Nr. 122 ()
Antwort auf Beitrag Nr.: 68.667.445 von 2brix am 01.07.21 21:24:51Herrliche Kaufgelegenheit fuer Leute, die den Zug verpasst hatten, nur meine Meinung...
Citius Pharmaceuticals | 2,600 $
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01.07.21 21:24:51
Beitrag Nr. 121 ()
CTXR
Motley Fool • 2 hours ago
Here's Why Citius Pharmaceuticals Stock Is Losing Ground Today

https://finance.yahoo.com/m/8d36e9d6-baed-36b0-afc5-04d7bf6a…
Citius Pharmaceuticals | 2,590 $
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CTXR - Citius Pharmaceuticals - Gute Pipeline plus Corona Phantasie