FDA casts doubt on Capricor's Duchenne stem cell therapy
The FDA says Capricor's Duchenne stem cell therapy deramiocel did not meet the Phase 3 trial endpoints, contradicting the company’s earlier claim of success and ahead of an upcoming hearing.
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FDA rejects Capricor's DMD cell therapy, citing need for more data
The FDA rejected Capricor Therapeutics' application for its cell therapy deramiocel aimed at treating Duchenne muscular dystrophy, citing insufficient evidence of effectiveness and requesting more clinical data.