Capricor to submit additional data to FDA after negative advisory committee vote on Duchenne therapy

Capricor Therapeutics announced it will request the FDA to review new data and analyses for its experimental treatment for Duchenne muscular dystrophy.

The move follows a recent negative vote from an FDA advisory committee, which had evaluated the therapy and expressed concerns.

By submitting additional information, Capricor hopes to narrow the indication and improve the chances of eventual regulatory approval.