Capricor shares plunge 64% after FDA questions Deramiocel evidence

Berger Montague PC announced a class action lawsuit against Capricor Therapeutics, Inc. on behalf of investors who purchased or acquired Capricor securities from Dec. 17, 2025, through July 26, 2026. The firm said investors have until Sept. 28, 2026, to seek appointment as lead plaintiff representative. Capricor, headquartered in San Diego, is a clinical-stage biotechnology company developing Deramiocel, a cell therapy intended for patients with Duchenne's muscular dystrophy. FDA (U.S. drug regulator) briefing documents released before the agency’s July 29 advisory committee meeting on Deramiocel’s biologics license application criticized changes to the pre-specified statistical analysis plan. The FDA said the final plan was not submitted for review before the application and that the changes were not scientifically justified, making related analyses post-hoc and exploratory. The agency said Deramiocel’s benefit-risk assessment appeared unfavorable without evidence of effectiveness. Capricor shares fell $12.70, or 64%, to close at $7.00 on July 27, 2026.

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Capricor shares plunge 64% after FDA questions Deramiocel evidence - CoinPost Terminal