Capricor says FDA inspection brought Form 483 with several observations

Capricor Therapeutics (CAPR) announced the completion of the Food and Drug Administration’s pre-license inspection of its San Diego manufacturing facility for Deramiocel, the company’s lead cell therapy candidate with a biologics license application under FDA review for potential approval in the treatment of Duchenne muscular dystrophy. The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or facility. “The observations were primarily related to routine quality systems and documentation practices. The Company is confident that the facility will meet the necessary requirements to support product licensure and, pending approval, commercial launch,” Capricor added. The FDA informed Capricor of its intent to hold the Advisory Committee meeting on July 30, although that date is pending confirmation by the FDA. “At the time of the mid-cycle review, no significant issues or major deficiencies were noted. A late-cycle meeting is planned for mid-July 2025,” the company added. The BLA for Deramiocel remains under priority review with a Prescription Drug User Fee Act action date of August 31.