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STAT+: Capricor Therapeutics’ Duchenne treatment is heading for an FDA rejection
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关键摘要
Capricor Duchenne therapy deramiocel faces near-certain FDA rejection
- FDA likely to reject Capricor's deramiocel for Duchenne mu…
- Company submitted open-label extension data as delay tactic
- Only path to approval is a new randomized clinical trial
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正文提要
This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.
Capricor Therapeutics is trying to stave off the Food and Drug Administration’s near-certain rejection of its cell therapy for Duchenne muscular dystrophy by submitting results from an open-label extension of its failed Phase 3 study.
It’s a stall tactic. Nothing more. The only option left for Capricor to secure approval of its treatment, called deramiocel, is to conduct an entirely new, randomized clinical trial.