Capricor Advances Deramiocel BLA Review for Duchenne DMD

Capricor Therapeutics ( (CAPR) ) has shared an update.

On March 10, 2026, Capricor Therapeutics said the U.S. Food and Drug Administration lifted a prior Complete Response Letter and resumed review of its Biologics License Application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy cardiomyopathy. The resubmission has been classified as Class 2, with a Prescription Drug User Fee Act target action date set for August 22, 2026, following additional data from the pivotal HOPE-3 Phase 3 trial, positioning Deramiocel as a potential first-in-class treatment for both skeletal and cardiac manifestations of DMD and marking a significant regulatory milestone for the company’s rare disease pipeline.

Capricor highlighted that, as of the FDA’s latest communication, no potential review issues had been identified in connection with the Deramiocel application. The company also underscored Deramiocel’s extensive clinical and regulatory backing, including its various special designations and an existing commercialization and distribution agreement for DMD in the U.S. and Japan with Nippon Shinyaku, which together could bolster its market entry prospects if full approval is ultimately granted.

The most recent analyst rating on (CAPR) stock is a Buy with a $60.00 price target. To see the full list of analyst forecasts on Capricor Therapeutics stock, see the CAPR Stock Forecast page.

Spark’s Take on CAPR Stock

According to Spark, TipRanks’ AI Analyst, CAPR is a Neutral.

Capricor Therapeutics’ overall score is primarily influenced by its financial challenges, including ongoing losses and cash flow issues. However, strong technical indicators and positive clinical trial results provide some optimism. The valuation remains a concern, but the potential for regulatory approval and commercialization could improve the outlook.

To see Spark’s full report on CAPR stock, click here.

More about Capricor Therapeutics

Capricor Therapeutics, Inc. is a NASDAQ-listed biotechnology company focused on developing transformative cell and exosome-based therapeutics for rare diseases. Its lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage development for Duchenne muscular dystrophy, while its StealthX exosome platform is being advanced preclinically for vaccine and targeted drug delivery applications.

Capricor’s programs target severe conditions with limited treatment options, particularly DMD, a progressive genetic disorder affecting roughly 15,000 individuals in the U.S. The company has secured multiple U.S. and European regulatory designations for Deramiocel, including Orphan Drug, RMAT, ATMP and Rare Pediatric Disease status, underscoring its strategic positioning in the rare disease and regenerative medicine markets.

Average Trading Volume: 1,236,624

Technical Sentiment Signal: Buy

Current Market Cap: $1.67B

Find detailed analytics on CAPR stock on TipRanks’ Stock Analysis page.