Capricor's Deramiocel Shows Durable Five-Year Benefit in Duchenne Muscular Dystrophy, Bolstering FDA Review
CAPR has more than doubled off its 52-week low of $4.3.
Summary
Capricor Therapeutics announced new positive five-year data from its HOPE-2 Open-Label Extension study for Deramiocel in Duchenne Muscular Dystrophy (DMD), demonstrating attenuated disease progression and stable cardiac function. These long-term results, along with previously reported positive HOPE-3 Phase 3 data, will be presented at the PPMD 2026 Annual Conference. This comprehensive clinical evidence significantly strengthens the company's Biologics License Application (BLA) currently under FDA review. The positive data is crucial, especially given the recent lawsuit against its U.S. distributor that could impact commercialization. The FDA's PDUFA target action date for Deramiocel is August 22, 2026.
At the time of this announcement, CAPR was trading at $27.50 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.8B. The 52-week trading range was $4.30 to $40.37. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.