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FDA advisory panel votes against Deramiocel's effectiveness for Duchenne cardiomyopathy treatment

Market News
30 Jul 2026
GlobeNewsWire
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Bearish
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The FDA advisory committee voted 9-3 that current evidence does not support the effectiveness of Capricor Therapeutics' Deramiocel for treating cardiomyopathy in Duchenne muscular dystrophy (DMD) patients. However, the vote was non-binding and focused on a narrower indication than Capricor proposed. The committee showed some support for Deramiocel's benefits on upper limb function based on Phase 3 trial data. Capricor remains committed to pursuing FDA approval by the August 22, 2026 target date, emphasizing the unmet medical need in DMD, a severe genetic disease with no approved cardiomyopathy treatments.

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