Newsfile Corp
20 Aug 2026, 02:48 UTC · 1h ago
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Capricor Therapeutics faces a class action lawsuit alleging that the company failed to disclose that the FDA had not agreed to changes in the statistical analysis plan for its Deramiocel clinical data. — Allegations of regulatory misalignment and lack of FDA agreement on clinical data analysis create significant uncertainty regarding the approval of a primary product candidate.
-0.70The lawsuit claims there is a substantial risk that the FDA could conclude the clinical results for Deramiocel do not provide substantial evidence of effectiveness for treating Duchenne muscular dystrophy. — Direct questioning of the efficacy of the core pipeline asset increases the risk of regulatory rejection, which is a binary catalyst for biotech valuations.
-0.60Investors who purchased Capricor securities between December 17, 2025, and July 26, 2026, have until September 28, 2026, to move for lead plaintiff status in the litigation. — While primarily a procedural legal deadline, the existence of an active class action can create a lingering overhang on the stock price.
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The company is facing a securities class action lawsuit alleging materially false statements regarding clinical data and FDA approval risks.
The company is mentioned as being subject to a securities class action lawsuit.
The company is mentioned in the context of a securities class action lawsuit.
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