capricor therapeutics

Preparing for the Deramiocel FDA Advisory Committee Meeting: How to Submit Written Testimony

The FDA has scheduled an Advisory Committee meeting for July 29, 2026 to review Deramiocel, Capricor’s investigational cell therapy for Duchenne muscular dystrophy. The meeting will be held in person with the option to participate…

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FDA Announces Advisory Committee Meeting to Review Capricor Therapeutics’ Biologics License Application for Deramiocel

The U.S. Food and Drug Administration (FDA) has scheduled an Advisory Committee meeting for July 29, 2026, to review Capricor Therapeutics’ Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for the treatment of…

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Capricor Therapeutics Announces Positive Data from HOPE-3 Study of Deramiocel

Capricor Therapeutics has announced additional analyses and new functional outcomes data from the Phase 3 HOPE-3 clinical trial of Deramiocel in Duchenne. Deramiocel is the company’s investigational cell therapy for the treatment of Duchenne cardiomyopathy….

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Capricor Therapeutics Announces New PDUFA Date for Deramiocel

Capricor Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has lifted the July 2025 Complete Response Letter and resumed review of the company’s Biologics License Application (BLA) for Deramiocel, an investigational cell…

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December 22, 2025

Watch: Capricor Therapeutics — HOPE-3 Community Update (Webinar Recording)

PPMD recently held a community webinar with Capricor Therapeutics, during which the company shared their most recent results from the Phase 3 HOPE-3 trial evaluating deramiocel (CAP-1002), Capricor’s investigational cell therapy for the treatment of…

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December 3, 2025

Capricor Therapeutics Announces Positive Topline Results from HOPE-3 Study of Deramiocel

Capricor Therapeutics today announced positive topline results from its pivotal Phase 3 HOPE-3 clinical trial evaluating Deramiocel, the company’s investigational cell therapy for the treatment of Duchenne muscular dystrophy. According to Capricor, the study met…

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Watch: Capricor Therapeutics – Regulatory Update & Clinical Insights on Deramiocel for Duchenne Cardiomyopathy

Capricor Therapeutics recently joined PPMD for a community webinar on Tuesday, July 29, 2025 to discuss the current status of Capricor’s Biologics License Application (BLA) for Deramiocel (CAP-1002). We discussed the regulatory implications of a…

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Capricor Therapeutics Receives Complete Response Letter Regarding Deramiocel (CAP-1002)

On July 9th, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Capricor’s Biologics License Application (BLA) for Deramiocel (CAP-1002), an investigational cell therapy for Duchenne cardiomyopathy. This decision means…

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Capricor Shares Regulatory Update on Deramiocel BLA for Duchenne

Capricor Therapeutics has shared a regulatory update related to its Biologics License Application (BLA) for Deramiocel, the company’s novel cell therapy for the treatment of Duchenne-associated cardiomyopathy. As part of the FDA’s ongoing review, Capricor…

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WATCH: Capricor Therapeutics – Update on Deramiocel for Cardiomyopathy in Patients with Duchenne (Webinar Recording)

Capricor Therapeutics recently joined PPMD for a community webinar to provide an update on their novel cell therapy, deramiocel (formerly CAP-1002), targeting cardiomyopathy in individuals living with Duchenne. The Capricor team discussed their ongoing Biologics…

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