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    Capricor DMD Spezialist

    eröffnet am 26.08.19 18:02:44 von
    neuester Beitrag 29.06.24 06:29:12 von
    Beiträge: 902
    ID: 1.310.137
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     Ja Nein
      Avatar
      schrieb am 29.06.24 06:29:12
      Beitrag Nr. 902 ()
      Capricor Therapeutics Announces Long-Term Benefit of Deramiocel (CAP-1002) in Both
      Skeletal Muscle and Cardiac Function in the HOPE-2 OLE Study in Duchenne Muscular Dystrophy

      -Results in Performance of the Upper Limb (PUL v2.0) Continue to
      Show Slowing of Disease Progression in Later-Stage DMD Patients-

      -Improvements Seen in Multiple Cardiac Endpoints Demonstrating
      Stabilization of Cardiac Function Over 3 Years of Treatment-

      -Pre-BLA Meeting with FDA Scheduled for Q3 2024 to Discuss Options to Expedite BLA Filing-


      „Die Ergebnisse der Open-Label-Studie sind für DMD-Patienten enorm wichtig, da sie nach 3 Jahren kontinuierlicher Behandlung mit Deramiocel anhaltende Vorteile für Skelett und Herz zeigten, was die potenziellen langfristigen Vorteile unterstreicht, die diese Therapie Patienten mit DMD bieten kann“, sagte Linda Marbán, Ph.D., Chief Executive Officer von Capricor. „Basierend auf unseren HOPE-2 OLE-Daten und früheren klinischen Ergebnissen planen wir, mit der US-amerikanischen Food and Drug Administration (FDA) Optionen zur Beschleunigung unserer Biologics License Application (BLA)-Einreichung zu besprechen. Wir arbeiten weiterhin eng mit der FDA zusammen, um Deramiocel den Patienten so schnell wie möglich zur Verfügung zu stellen, und freuen uns darauf, weitere Updates mitzuteilen, sobald diese verfügbar sind. Wir danken den Patienten, ihren Familien und der Duchenne-Gemeinschaft im Allgemeinen für ihre fortgesetzte Zusammenarbeit mit uns während der Entwicklung dieser vielversprechenden Therapie.“

      https://finance.yahoo.com/news/capricor-therapeutics-announc…
      Capricor Therapeutics | 4,770 $
      Avatar
      schrieb am 12.06.24 05:55:58
      Beitrag Nr. 901 ()
      “The most recent meeting had several very important outcomes;
      the first of which was that the FDA has agreed to a pre-BLA meeting based on their review of our clinical data from HOPE-2,
      HOPE-2 open label extension (OLE) and available data from HOPE-3. This key agreement will allow us
      to begin our BLA filing with a rolling submission planned to initiate in the third quarter of 2024
      .”

      The rolling submission process allows for the submission of pre-agreed components of the BLA
      to be submitted as they are completed, which can streamline the regulatory review process and de-risk the BLA.
      Capricor plans to further outline the submission schedule with the FDA in the coming months.

      “We continue to make significant progress on this program as we are awaiting final data in the fourth quarter of 2024
      from our already enrolled HOPE-3 pivotal trial and prepare for potential commercialization, including completion
      of our commercial manufacturing facility and actively preparing for our pre-BLA meeting and rolling BLA submission.

      https://finance.yahoo.com/news/capricor-therapeutics-announc…
      Capricor Therapeutics | 5,550 $
      Avatar
      schrieb am 04.06.24 15:44:02
      Beitrag Nr. 900 ()
      Capricor Therapeutics Announces Positive 3-Year Efficacy Results from HOPE-2
      Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy
      https://finance.yahoo.com/news/capricor-therapeutics-announc…
      Capricor Therapeutics | 5,290 €
      Avatar
      schrieb am 14.05.24 13:30:02
      Beitrag Nr. 899 ()
      First Quarter 2024
      –Phase 3, HOPE-3 Trial (Cohort A) of CAP-1002 in Duchenne Muscular Dystrophy Fully Enrolled;
      On Track to Report Top-Line Data in Q4 2024

      –Positive Type-B CMC FDA Meeting held in Q1; Company Aligned with FDA on Demonstration of Non-Clinical Comparability,
      A Major Milestone on Path to CMC Clearance for BLA

      –Received First Milestone Payment of $10 Million under U.S. Distribution
      and Commercialization Agreement with Nippon Shinyaku in Q1

      –Recent FDA Feedback Supports Requests for a Pre-BLA Meeting and Subsequent
      Rolling BLA Submission at Upcoming Type-B Clinical FDA Meeting in May 2024

      –Plan to Report 3-Year Data from HOPE-2 Open-Label Extension (OLE) Trial in Q2 2024

      “Capricor continues to make tremendous progress across our pipeline marked by significant advancements in our CAP-1002 cell therapy program for the treatment of Duchenne muscular dystrophy (DMD),” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “With enrollment completed in Cohort A of our Phase 3 pivotal trial, we further aligned with the U.S. Food and Drug Administration (FDA) on key CMC (chemistry manufacturing and controls) deliverables necessary for the filing of a Biologics License Application (BLA) including the establishment of non-clinical comparability, a major milestone on the path to clearance for a BLA submission. We are appreciative of the FDA’s continued guidance under our RMAT designation and we will provide further updates on our plans as they become available. Furthermore, we continue to work diligently with our partner, Nippon Shinyaku (U.S. subsidiary: NS Pharma, Inc.) as we prepare for the potential launch of CAP-1002. Looking ahead, later this quarter, we plan to meet with FDA to continue to discuss options for potential expedited approval pathways as well as announce the 3-year HOPE-2 OLE results.”

      Dr. Marbán, continued, “We continue our efforts to advance our proprietary StealthX™ exosome platform to leverage exosomes for our vaccine program as well as for therapeutic development. This quarter, we announced a collaboration for our exosome-based multivalent vaccine for the prevention of SARS-CoV-2 with the National Institute of Allergy and Infectious Diseases (NIAID) where they will conduct and fully fund a Phase 1 clinical trial, subject to regulatory approval. We continue to remain focused on advancing this program through partnerships and other non-dilutive sources of funding.”

      Cash position: Cash, cash equivalents and marketable securities totaled approximately $ 39.9 million as of March 31, 2024 compared to approximately $39.5 million as of December 31, 2023. In the first quarter of 2024, the Company received $10.0 million from the first milestone payment under our U.S. Distribution and Commercialization Agreement with Nippon Shinyaku and raised approximately $2.3 million in net proceeds through issuances of common stock at an average price of approximately $5.33 per share under its at-the-market offering program.
      https://finance.yahoo.com/news/capricor-therapeutics-reports…
      Capricor Therapeutics | 5,030 €
      Avatar
      schrieb am 24.04.24 15:13:22
      Beitrag Nr. 898 ()
      -Company Aligned with FDA on Demonstration of Non-Clinical Comparability;
      Allowing for Immediate Use of San Diego Manufacturing Facility-

      -FDA Feedback Supports Requests for a Pre-BLA Meeting and
      Subsequent Rolling BLA Submission Following Upcoming Q2 Type-B FDA Meeting-

      -Company Granted Subsequent Type-B Clinical Meeting with FDA
      in Second Quarter to Continue to Discuss Pathway to BLA-

      https://finance.yahoo.com/news/capricor-therapeutics-announc…
      Capricor Therapeutics | 4,950 €

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      0,1520EUR +4,83 %
      Countdown für die FDA-Zulassung!mehr zur Aktie »
      Avatar
      schrieb am 28.03.24 13:13:21
      Beitrag Nr. 897 ()
      Antwort auf Beitrag Nr.: 75.498.168 von zivio am 21.03.24 23:29:53Hält sich aber weiter tapfer Stabil bei 6€
      Capricor Therapeutics | 6,240 €
      Avatar
      schrieb am 21.03.24 23:29:53
      Beitrag Nr. 896 ()
      Capricor Therapeutics to Present at Upcoming Investor Conferences


      SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that the Company is scheduled to present at two upcoming investor conferences.


      Event: H.C. Wainwright 2nd Annual Cell Therapy Conference
      Presentation: March 26, 2024 at 2:00 p.m. ET
      Format: Virtual fireside chat and one-on-one meetings

      Event: Cantor Fitzgerald’s Muscular Dystrophy Symposium
      Presentation: April 3, 2024 at 1:30 p.m. ET
      Format: Virtual fireside chat


      Dr. Linda Marbán, Capricor’s chief executive officer will present updates on Capricor’s recent progress on its lead program of CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD) as well as other general scientific and corporate updates. For more information on these presentations, please visit Capricor's website at http://capricor.com/news/events/.


      https://www.capricor.com/investors/news-events/press-release…
      Capricor Therapeutics | 6,880 $
      Avatar
      schrieb am 19.03.24 16:56:57
      Beitrag Nr. 895 ()
      Manipulation bei Biotechs
      Ich möchte gar nicht wissen, wie sehr sich Shortseller in Biotech die Taschen voll stopfen. Man braucht leider sehr viel Geduld, tiefe Taschen zum Nachkaufen und Eier aus Stahl. Wenn ich bedenke, zu welchem Kurs ich vor Jahren Viking verkauft habe, werde ich den Fehler hoffentlich bei dem nächsten Multibagger nicht wiederholen.
      Mit Blick auf die Market Cap von Sarepta und deren oft zweifelhaften Studienergebnissen ist bei Capricor sehr viel Luft nach oben, falls endlich die ersehnten Erfolgsmeldungen kommen.
      Capricor Therapeutics | 7,130 $
      Avatar
      schrieb am 15.03.24 11:25:57
      Beitrag Nr. 894 ()
      Antwort auf Beitrag Nr.: 75.457.776 von bonDiacomova am 15.03.24 05:51:27
      Zitat von bonDiacomova: ....wie sich m.e. der markt manipulieren laesst


      in beide Richtungen / bei beiden Werten wirklich erstaunlich.

      Meine Meinung - frei nach Pipi Langstrumpf:

      Zwei mal drei macht vier,
      widewidewitt und drei macht neune,
      ich mach mir die Welt,
      widewide wie sie mir gefällt.
      Capricor Therapeutics | 5,660 €
      Avatar
      schrieb am 15.03.24 05:51:27
      Beitrag Nr. 893 ()
      F & F
      anal lysten

      caprisonne steigt
      Earnings Beat:
      Capricor Therapeutics, Inc. (NASDAQ:CAPR) Just Beat Analyst Forecasts,
      And Analysts Have Been Lifting Their Forecasts
      https://finance.yahoo.com/news/earnings-beat-capricor-therap…

      ocup faellt
      Ocuphire Pharma Full Year 2023 Earnings:
      Misses Expectations
      https://finance.yahoo.com/news/ocuphire-pharma-full-2023-ear…

      Earnings Update:
      Ocuphire Pharma, Inc. (NASDAQ:OCUP) Just Reported And Analysts Are Trimming Their Forecasts
      https://finance.yahoo.com/news/earnings-ocuphire-pharma-inc-…

      beide haben noch garkeine Earnings - wie sich m.e. der markt manipulieren laesst
      Capricor Therapeutics | 6,170 $
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      Capricor DMD Spezialist