Capricor plunges after FDA declines to approve muscle disorder therapy

Shares of therapy developer Capricor Therapeutics CAPR.O fall 31.7% to $7.79

Company says the U.S. FDA has declined to approve its cell therapy for a type of muscle disorder

FDA says co's marketing application for its therapy, Deramiocel, does not meet statutory requirement for substantial evidence of effectiveness

Company plans to resubmit marketing application for the therapy in Q3 2025

*B. Riley Securities says "While the outcome seems to suggest a less flexible FDA, we view this as evidence of a pragmatic FDA in the face of Ph2 data that simply did not carry technical strength"

"We remain optimistic that deramiocel will eventually be approved. As we had also outlined, whether the approval is for DMD cardiomyopathy or skeletal myopathy (or both), we would see more than $1 billion sales potential for the product," says brokerage Oppenheimer

Including session moves, CAPR down 39.1% YTD