Capricor Submits FDA Application for Deramiocel

Capricor Therapeutics has completed the submission of its Biologics License Application (BLA) to the FDA for deramiocel, an investigational cell therapy aimed at treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD). This marks a pivotal step for the company, as CEO Linda Marbán emphasized the importance of the BLA in potentially transforming the treatment landscape for DMD patients. The application is supported by positive clinical data from the HOPE-2 study indicating improvements in cardiac function. Capricor is set to receive a $10 million milestone payment from Nippon Shinyaku, which holds licensing rights for deramiocel in the U.S. and Japan. If approved, deramiocel could significantly impact the management of DMD-related cardiac complications, with Capricor also seeking a priority review from the FDA. The positive news has led to an increase in Capricor's stock price and heightened retail investor sentiment.