GlobeNewsWire
21 Aug 2026, 10:36 UTC · 1h ago
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An FDA advisory committee voted 9-3 that available evidence does not support the efficacy of Capricor's lead product candidate, Deramiocel, for treating DMD-associated cardiomyopathy. — Negative advisory committee votes significantly decrease the probability of FDA approval for a lead asset, directly threatening the company's primary value driver.
-0.90The FDA raised concerns that Capricor made post-hoc changes to its statistical analysis plan for Deramiocel shortly before the clinical database was unblinded. — Allegations of manipulating analysis plans to achieve desired results undermine the integrity of clinical data and damage regulatory trust.
-0.70Capricor Therapeutics and its executives are facing a securities fraud class action lawsuit following a collapse in stock price. — Litigation creates additional financial liability and management distraction, though it is a lagging indicator of the primary clinical failure.
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The FDA previously issued a Complete Response Letter stating Deramiocel's application did not meet statutory requirements for substantial evidence of effectiveness. — A CRL confirms a regulatory rejection, necessitating costly and time-consuming additional clinical trials.
-0.40Which stocks this story touches
The company is facing a securities fraud class action lawsuit following a massive stock drop and negative FDA feedback regarding its lead product candidate.
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