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FDA Panel Votes 9–3 Against Deramiocel; Yet Capricor Pursues a New FDA Path

Capricor Therapeutics plans to amend its BLA for deramiocel after an FDA advisory committee voted 9–3 against finding substantial evidence of effectiveness for Duchenne muscular dystrophy cardiomyopathy. During its August 13 earnings call, the company said the amendment will add
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FDA Panel Votes 9–3 Against Deramiocel; Yet Capricor Pursues a New FDA Path

Capricor Called HOPE-3 a Success, FDA Says Deramiocel Evidence Falls Short

Capricor Therapeutics shares plunged about 65% on Monday after FDA reviewers questioned whether deramiocel benefits patients with Duchenne muscular dystrophy. The agency released its assessment before a July 29 advisory committee meeting. Although Capricor calls HOPE-3 Phase 3 study positive,
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Capricor Called HOPE-3 a Success, FDA Says Deramiocel Evidence Falls Short