Capricor Therapeutics Shares Dive Before Key Review as FDA Panel Challenges Data

Capricor Therapeutics' shares fell after an FDA briefing document questioned the efficacy of its investigational cell therapy, Deramiocel, for Duchenne muscular dystrophy (DMD) ahead of a key FDA Advisory Committee meeting. The FDA stated that data from studies HOPE-3 and HOPE-2 did not provide substantial evidence of effectiveness and that HOPE-3 missed its primary endpoint. Despite this, Capricor Therapeutics maintained that its Phase 3 HOPE-3 results showed significant benefits and that the company had engaged transparently with the FDA.