GlobeNewsWire
27 Jul 2026, 16:44 UTC · 2h ago
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FDA briefing documents for deramiocel concluded that data did not provide substantial evidence of effectiveness and noted the application relied on only one pivotal trial. — Directly undermines the likelihood of regulatory approval for the company's primary cell therapy candidate, leading to a massive loss in valuation.
-0.90Capricor Therapeutics shares fell more than 60% following the release of the FDA briefing documents. — Reflects immediate and severe market devaluation of the company's equity.
-0.70Law firm Block & Leviton is investigating Capricor Therapeutics for potential securities law violations regarding representations of the regulatory path for deramiocel. — Introduces significant legal risk and potential for costly class-action settlements on top of the drug failure.
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Reports indicate Capricor made multiple changes to its statistical analysis plan after the study was completed, raising concerns about data manipulation to generate a positive outcome. — Damages corporate credibility and suggests potential scientific misconduct, which may further alienate investors.
-0.40Which stocks this story touches
A securities fraud class action lawsuit has been filed against the company.
The company is being investigated for securities fraud following a 60% stock price drop and negative FDA briefing documents.
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