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Capricor thrown for another loop as FDA sets adcomm for DMD cardiomyopathy therapy

The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.

June 26, 2026

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4 min read

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Heather McKenzie

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Duchenne muscular dystrophy

Capricor Shares Rise as FDA Sets August Decision Date for Rejected Duchenne Therapy

Capricor Therapeutics’ deramiocel was rejected in July 2025, potentially caught between Nicole Verdun, a former top biologics regulator at the FDA, and outgoing Vinay Prasad, director of the Center for Biologics Evaluation and Research.

March 11, 2026

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2 min read

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Tristan Manalac

Press Releases

Capricor Therapeutics to Present at Upcoming Investor Conferences - June 8, 2026

June 8, 2026

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3 min read

Duchenne muscular dystrophy

Capricor Heads Back to FDA With Pivotal Results for DMD Cardiomyopathy Therapy

Six months after receiving a surprise rejection due to what the FDA called “lack of substantial evidence of effectiveness,” Capricor’s cell therapy deramiocel showed significant benefits in upper-limb function and slowed decline in cardiac function in a Phase III trial.

December 3, 2025

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3 min read

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Heather McKenzie

Press Releases

Capricor Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

May 13, 2026

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13 min read

Press Releases

Capricor to Present Positive Five-Year HOPE-2 OLE Data and HOPE-3 Phase 3 Results for Deramiocel in Duchenne Muscular Dystrophy at PPMD 2026 Annual Conference

June 26, 2026

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7 min read

Press Releases

Capricor Therapeutics to Report First Quarter 2026 Financial Results and Provide Recent Corporate Update on May 12

May 4, 2026

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4 min read

Glowing red neon heartbeat pulse rate line. Health and Medical concept. EKG Pulse Wave, cardiogram and rhythm

Duchenne muscular dystrophy

With Prasad Back at FDA, Capricor To Fight DMD Cardiomyopathy Rejection

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset.

August 20, 2025

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7 min read

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Heather McKenzie