Shares of Capricor Therapeutics, Inc. (CAPR) surged 12% on Tuesday morning after the biotechnology company announced the U.S. FDA's acceptance and priority review of its Biologics License Application for Deramiocel to treat Duchenne muscular dystrophy.
CAPR is currently trading at $15.39, up $1.72 or 12.58%, on the Nasdaq. The stock opened its trading at $15.11 after closing Monday at $13.67. The stock has traded between $3.52 and $23.40 in the past 52-week period.
Capricor Therapeutics announced that the U.S. Food and Drug Administration has accepted for review its Biologics License Application seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy cardiomyopathy. Additionally, the FDA granted the BLA Priority Review with a Prescription Drug User Fee Act ("PDUFA") target action date of August 31, 2025, and at this time, the FDA has not identified any potential review issues.
"We are thrilled to announce the acceptance of our BLA bringing us one step closer to providing this first-in-class treatment for Duchenne-cardiomyopathy, a condition for which there are no approved therapies," said Linda Marbán, Ph.D., Chief Executive Officer of Capricor.
"If our application is successful, we expect deramiocel to be a lifelong treatment, administered quarterly, with the potential to be widely adopted across the DMD-cardiomyopathy treatment landscape. We want to extend our appreciation to the patients, their families and advocates who continue to work with Capricor and to the FDA for its commitment to accelerating treatments for DMD."
For comments and feedback contact: editorial@rttnews.com
Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.