Newsfile Corp
17 Aug 2026, 16:50 UTC · 1h ago
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Capricor Therapeutics faces allegations that it lacked FDA agreement on changes to the statistical analysis plan for its Deramiocel BLA resubmission. — Lack of FDA alignment on primary analysis plans is a major red flag for drug approval probability, directly impacting the company's core asset value.
-0.80A class action lawsuit claims there is a substantial risk to the regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy. — Regulatory failure for a lead candidate is a binary event that typically results in significant share price devaluation for small biotech firms.
-0.70The Rosen Law Firm is seeking a lead plaintiff for a securities class action regarding Capricor Therapeutics with a deadline of September 28, 2026. — While legal notices are common, a formal class action creates ongoing litigation overhang and potential financial liabilities.
-0.20Which stocks this story touches
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The company is facing a class action lawsuit alleging materially false and misleading statements regarding FDA clinical data analysis for Deramiocel.
The company is mentioned as the subject of a securities class action lawsuit.
The company is mentioned as the subject of a securities class action lawsuit for investors with losses exceeding $100K.
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