Newsfile Corp
05 Sept 2026, 12:42 UTC · 1h ago
NewsImpactScreener rates every claim in this story for market impact and maps it to the tickers most exposed.
Analysis by Kasper Rasmussen · Founder & analyst
What the story claims
3 claims · each scored for market impact
An FDA AdCom panel voted 9-3 that available evidence does not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy. — Negative clinical efficacy conclusions from an FDA advisory panel significantly decrease the probability of drug approval, the primary value driver for a biotech company.
-0.90The FDA released briefing documents stating the benefit-risk assessment for Deramiocel appears unfavorable due to a lack of evidence of effectiveness. — Direct negative feedback from the regulator regarding a lead product candidate typically leads to severe valuation write-downs.
-0.80A federal securities class action lawsuit alleges Capricor misled investors by changing statistical analysis plans for Deramiocel without FDA agreement. — Litigation regarding regulatory misconduct introduces legal liability, potential fines, and damages investor trust in management.
-0.50Which stocks this story touches
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The company is facing a federal securities class action lawsuit following a massive stock price collapse and FDA reports suggesting its lead drug lacks evidence of effectiveness.
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3h ago
