GlobeNewsWire
17 Aug 2026, 19:50 UTC · 1h ago
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An FDA advisory panel voted 9-3 that available evidence does not support the efficacy of Capricor's deramiocel for treating DMD-associated cardiomyopathy. — A negative advisory committee vote is a primary indicator of a failed BLA and suggests the drug will not reach market.
-0.90The FDA criticized Capricor's data analysis methods, stating the conversion of raw change to percent change and back was not scientifically justified. — Allegations of unjustified data manipulation undermine the scientific integrity of the trial and the likelihood of regulatory approval.
-0.70A securities fraud class action lawsuit has been filed against Capricor alleging the company misled investors regarding its statistical analysis plans and FDA alignment. — Litigation creates additional financial liability and reputational risk, though it is secondary to the drug's clinical failure.
-0.40Which stocks this story touches
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The company faces a securities fraud class action lawsuit following negative FDA feedback and a panel conclusion that its therapy lacks efficacy.
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