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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

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 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

View of Chicago Skyline from North Avenue Beach

Neuroscience

AAN 2026: J&J, Kyverna, Capricor and Praxis showcase practice-changing data

This year’s American Academy of Neurology meeting included a presentation that could one day set a new treatment standard for myasthenia gravis.

April 23, 2026

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4 min read

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Tristan Manalac

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

Press Releases

Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA

March 10, 2026

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6 min read

Press Releases

Capricor Therapeutics Announces Late-Breaking Presentation of HOPE-3 Phase 3 Results at the American Academy of Neurology 2026 Annual Meeting