From GlobeNewswire: 2025-03-19 16:05:00

Capricor Therapeutics has received FDA acceptance for its BLA for deramiocel to treat DMD cardiomyopathy, with a PDUFA target action date of August 31, 2025. Positive data from the HOPE-2 trial showed a 52% slowing of disease. The company received a $10 million milestone payment and has a cash balance of $152 million. Capricor aims to bring deramiocel to market.

In 2024, Capricor made significant progress towards commercializing deramiocel for the treatment of Duchenne-cardiomyopathy. The company’s BLA has been granted Priority Review by the FDA, with a PDUFA action date set for August 31, 2025. Deramiocel has shown promising results in preserving cardiac and skeletal muscle function in DMD patients. Capricor also expanded its manufacturing capacity to support commercial production.

Capricor’s financial results for the fourth quarter of 2024 showed total revenues of approximately $11.1 million. The company’s cash position stood at approximately $151.5 million as of December 31, 2024, compared to $39.5 million in 2023. Capricor reported a net loss of approximately $7.1 million for the fourth quarter of 2024, with a net loss of $40.5 million for the year.

Looking ahead, Capricor believes its current cash reserves will support operations and capital requirements into 2027. The company has upcoming presentations at the Piper Sandler & Co. Cardio Day and the JonesTrading Technology and Innovation Conference in April 2025. Capricor is dedicated to advancing cell and exosome-based therapeutics for rare diseases, with a focus on bringing deramiocel to market for DMD cardiomyopathy patients.

Duchenne Muscular Dystrophy is a genetic disorder characterized by progressive muscle weakness and inflammation. Capricor’s deramiocel, an allogeneic cardiac-derived cell therapy, has shown promising results in preclinical and clinical studies for preserving muscle function in DMD patients. Capricor is committed to developing transformative treatments for rare diseases and pushing the boundaries of possibility in the field of biotechnology.



Read more at GlobeNewswire:: Capricor Therapeutics Reports Fourth Quarter and Full Year