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11.07.25 - 13:15
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Capricor -60%: FDA-Tiefschlag – und jetzt? (Sharedeals)
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Hiobsbotschaft für Capricor Therapeutics und seine Aktionäre: Der US-Gesundheitsbehörde FDA reichen die bisher eingereichten Daten zum Medikamentenkandidaten Deramiocel nicht aus. Die Aktie verliert vorbörslich rund 60% an Wert. Wie geht es jetzt weiter? Der Zulassungsantrag für Deramiocel zur Behandung von Kardiomyopathie im Zusammenhang mit der Duchenne-Muskeldystrophie hat in der bisherigen Ausführung keine Aussicht auf Erfolg. […]
The post Capricor -60%: FDA-Tiefschlag – und jetzt? first appeared on sharedeals.de....
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11.07.25 - 12:33
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Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy (GlobeNewswire EN)
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SAN DIEGO, July 11, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel, the Company's lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD)....
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20.06.25 - 15:27
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Capricor Therapeutics Announces Positive 4-Year Data from HOPE-2 Open-Label Extension Study of Deramiocel in Duchenne Muscular Dystrophy (GlobeNewswire EN)
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SAN DIEGO, June 20, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced positive four-year safety and efficacy results from its ongoing HOPE-2 Open-Label Extension (OLE) study of Deramiocel, the Company's lead cell therapy candidate for Duchenne Muscular Dystrophy (DMD). The data will be featured in the session titled “Therapies that Slow Progression” at the Parent Project Muscular Dystrophy (PPMD) 2025 Annual Conference, taking place June 21, 2025, in Las Vegas, Nevada....
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17.06.25 - 15:03
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Capricor Therapeutics Announces Orphan Drug Designation for Becker Muscular Dystrophy and Regulatory Progress for Duchenne Muscular Dystrophy Program (GlobeNewswire EN)
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SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Deramiocel, the company's lead cell therapy candidate, for the potential treatment of Becker Muscular Dystrophy (BMD). This designation strengthens Capricor's strategic position as it advances a fully integrated platform targeting the cardiac and skeletal complications of muscular dystrophy and expands the commercial potential of its lead asset....
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11.06.25 - 15:27
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Capricor Therapeutics Announces Key Regulatory Updates for its Duchenne Muscular Dystrophy Program (GlobeNewswire EN)
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SAN DIEGO, June 11, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the successful completion of the U.S. Food and Drug Administration's (FDA) Pre-License Inspection (PLI) of its San Diego manufacturing facility for Deramiocel, the Company's lead cell therapy candidate with a Biologics License Application (BLA) under FDA review for potential approval in the treatment of Duchenne Muscular Dystrophy (DMD). The inspection concluded with a Form 483 containing several observations. The Company has submitted its responses to the FDA, none of which required material changes to the cGMP process or facility. The observations were primarily related to routine quality systems and documentation practices. The Company is confident that the facility will meet the necessary requirements to support product licensure and, pending approval, commercial launch....
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