Capricor to submit supplemental data to FDA for Duchenne therapy after advisory panel rejection
Capricor Therapeutics plans to submit additional data and analyses to the FDA for its Duchenne muscular dystrophy treatment. The move follows a negative advisory committee vote. The company hopes to gain approval for a more limited indication.
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Capricor's Duchenne therapy faces likely FDA denial · Drug development
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Original headline: “Capricor, seeking lifeline for Duchenne therapy, says it will ask FDA to review additional data.” Browse more stories.