CTXR - Citius Pharmaceuticals - Gute Pipeline plus Corona Phantasie (Seite 3)
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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
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
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
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
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
Antwort auf Beitrag Nr.: 68.668.840 von ooy am 02.07.21 05:08:38
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.
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.
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...
Trading Spotlight
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…
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…
Der tut weh
Antwort auf Beitrag Nr.: 68.663.518 von zzman31 am 01.07.21 15:27:52Die Erwartung war wohl, dass der Trial vorzeitig abgebrochen wird...
Puh, was ist denn jetzt passiert?? Hammer Absturz!
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