PRNewsWire
13 Sept 2026, 19:53 UTC · 1h ago
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What the story claims
3 claims · each scored for market impact
Capricor Therapeutics faces allegations that it resubmitted a Biologics License Application (BLA) for Deramiocel using statistical analysis changes not agreed upon by the FDA. — FDA disagreement on primary endpoints or analysis plans significantly increases the risk of a Complete Response Letter (CRL) or rejection of a drug candidate.
-0.80The lawsuit claims there is a substantial risk to the regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy. — Directly challenges the viability of the company's lead product candidate, which is a primary driver of valuation for biotech firms.
-0.60A securities fraud class action lawsuit has been filed against Capricor Therapeutics claiming the company made materially misleading statements about its business prospects. — Litigation creates legal overhang and suggests potential internal governance or transparency issues, which typically weigh on stock sentiment.
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The company is facing a securities fraud class action lawsuit alleging misleading statements regarding FDA interactions and clinical data for Deramiocel.
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