Capricor Therapeutics stock soars, FDA resumes BLA review

LootboxPhobia · 2026-03-10T15:55:32+00:00

Capricor Therapeutics Inc's stock price surged 14.3% due to the resumption of review for its Deramiocel biological product license application. The FDA found no review issues and set a new target action date. This therapy is expected to become the first treatment to address both Duchenne muscular dystrophy and cardiomyopathy.

LootboxPhobia

2026-03-10 15:55:32

Abstract generation in progress

Investing.com – Capricor Therapeutics Inc (NASDAQ:CAPR) stock surged 14.3% on Tuesday after the company announced that the U.S. Food and Drug Administration (FDA) had withdrawn the complete response letter and resumed review of its Deramiocel biologic license application. Deramiocel is an investigational cell therapy for treating Duchenne muscular dystrophy cardiomyopathy.

The FDA classified this resubmission as a Class 2 resubmission and set a target action date of August 22, 2026, under the Prescription Drug User Fee Act. According to the announcement, the FDA found no potential review issues in its response to the company.

The BLA application was supported by positive results from the pivotal HOPE-3 Phase 3 clinical trial, including meeting the primary endpoint and all secondary endpoints with controlled Type I error. Deramiocel is expected to become the first therapy to address both skeletal and cardiac manifestations of Duchenne muscular dystrophy.

Capricor received the complete response letter from the FDA in July 2025. After submitting data and supporting documents from the HOPE-3 trial, the FDA resumed review of the application.

The company expects that, upon potential approval of Deramiocel, it will be eligible for a priority review voucher. In February 2026, Congress extended the Rare Pediatric Disease Priority Review Voucher (PRV) program to September 30, 2029.

H.C. Wainwright analyst Joseph Pantginis commented, “Looking back, Capricor previously submitted additional data and supporting documents for the HOPE-3 Phase 3 study in response to the CRL. According to management, the FDA did not identify any potential review issues in the resubmission.”

Jones Trading analyst Catherine Novack said, “The recent departure of CBER director Dr. Vinay Prasad increases the likelihood of approval. His unpredictable decisions and public opposition to Deramiocel add regulatory risk.”

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