Capricor CEO hints at possible lawsuit after FDA panel rejects Duchenne cardiomyopathy therapy

An FDA Cellular, Tissue, and Gene Therapies advisory committee voted 9-3 against recommending Capricor Therapeutics' cell therapy deramiocel for Duchenne muscular dystrophy cardiomyopathy. The panel concluded the treatment was not effective for the intended indication.

Capricor chief executive Linda Marban said she is open to meeting with the agency to find a path forward, but she did not rule out pursuing legal action if the FDA remains inflexible.

The negative recommendation sent the company's shares sharply lower, reflecting investor concern over the setback for the biotech's lead candidate.

The FDA has not commented on whether it anticipates a legal challenge, leaving the future of the therapy uncertain.