Capricor Therapeutics

CAPR

Market cap $2.01B

Capricor Therapeutics is upgraded from 'Hold' to 'Buy' following FDA acceptance of the HOPE-3 clinical study report for Deramiocel in DMD cardiomyopathy. The FDA lifted the Complete Response Letter and set a PDUFA date of August 22, 2026, without requiring new studies, increasing regulatory clarity. Phase 3 HOPE-3 data showed Deramiocel slowed disease progression by 54% [PUL] and 91% [LVEF], with additional functional and fibrosis benefits.

Capricor posted a quarterly loss of 62 cents per share, missing the consensus estimate of a 54-cent loss and worsening from a 16-cent loss in the prior-year period.

Capricor Therapeutics, Inc. (CAPR) Q4 2025 Earnings Call Transcript

SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update.

SAN DIEGO, March 12, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced additional analyses and new functional outcomes data from the Phase 3 HOPE-3 clinical trial of Deramiocel in Duchenne muscular dystrophy (DMD), which were presented yesterday at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida.

Capricor Therapeutics Inc (NASDAQ:CAPR) shares are trading higher Tuesday morning after the biotech company said the U.S. Food and Drug Administration resumed its review of the Biologics License Application for Deramiocel, its experimental treatment for Duchenne muscular dystrophy cardiomyopathy, and assigned a new PDUFA target action date of August 22, 2026.

SAN DIEGO, March 10, 2026 (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 lifted the previously issued Complete Response Letter and resumed review of its Biologics License Application (“BLA”) seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy (“DMD”) cardiomyopathy. The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act (“PDUFA”) target action date of August 22, 2026.

SAN DIEGO, March 10, 2026 (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 lifted the previously issued Complete Response Letter and resumed review of its Biologics License Application (“BLA”) seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy (“DMD”) cardiomyopathy. The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act (“PDUFA”) target action date of August 22, 2026.

The U.S. Food and Drug Administration Commissioner Marty Makary confirmed on Friday that Dr. Vinay Prasad, head of its Center for Biologics Evaluation and Research (CBER), is set to leave his position in April.

CAPR said the FDA wants the full HOPE-3 study report for Deramiocel and confirmed no new clinical trials are needed.