Capricor Therapeutics, Inc. (CAPR)

Capricor Therapeutics' stock experienced volatility in the past six months. The FDA issued a Complete Response Letter (CRL) for Deramiocel in July 2025, causing a stock price decline. In September 2025, a regulatory update after a Type A meeting with the FDA clarified the path forward for potential approval. Positive Phase 3 HOPE-3 trial results for Deramiocel in DMD were announced in December 2025, leading to a surge in the company's share price. Capricor completed the submission of its Biologics License Application (BLA) for Deramiocel to the FDA in January 2026, but the stock slid after the FDA requested more HOPE-3 data.

Information regarding demand seasonality for Capricor Therapeutics, Inc.'s products and services is not explicitly available. Demand is likely driven by disease prevalence, clinical trial outcomes, regulatory approvals, and physician prescriptions rather than seasonal consumer patterns.

Capricor Therapeutics, Inc. is a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases. Their lead product, Deramiocel (CAP-1002), is in Phase 3 clinical development for Duchenne muscular dystrophy (DMD), targeting cardiomyopathy. They are also advancing their StealthX™ exosome platform for vaccinology and targeted delivery of therapeutics, including potential COVID-19 vaccines.

Capricor Therapeutics, Inc. is headquartered in San Diego, California, United States, with primary sales generated in the United States.

Capricor Therapeutics' brand reputation was negatively impacted by the FDA's Complete Response Letter in July 2025, but positive Phase 3 HOPE-3 study results in December 2025 boosted confidence and stock value. Analysts maintain a generally positive outlook, with a consensus rating of "Moderate Buy".

Capricor Therapeutics' stock ownership includes institutional investors (12.36%), insiders (1.08%), and public companies and individual investors (86.56%). Major institutional owners include BlackRock, Inc., Vanguard Group Inc., and others. Nippon Shinyaku Co., Ltd. owns 9.56% of the company's stock and is a strategic partner.