Newsfile Corp
01 Sept 2026, 12:45 UTC · 1h ago
NewsImpactScreener rates every claim in this story for market impact and maps it to the tickers most exposed.
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What the story claims
3 claims · each scored for market impact
An FDA advisory committee (AdCom) voted 9-3 that available evidence does not support the efficacy of deramiocel for treating DMD-associated cardiomyopathy. — A negative AdCom vote is a critical precursor to FDA rejection, severely damaging the commercial viability of the company's primary drug candidate.
-0.90The FDA released briefing documents stating that the benefit-risk assessment for deramiocel appears unfavorable due to a lack of evidence of effectiveness. — Direct negative feedback from the regulator regarding the drug's risk-benefit profile significantly lowers the probability of regulatory approval.
-0.80A federal securities class action lawsuit alleges Capricor executives misled investors by changing clinical data analysis plans without FDA agreement. — Allegations of regulatory misconduct and misleading statements create legal liability and damage corporate governance credibility.
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The company is facing a securities class action lawsuit following a massive stock price collapse due to unfavorable FDA feedback and a negative AdCom vote on its lead drug candidate.
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GlobeNewsWire
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