Newsfile Corp
12 Aug 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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FDA briefing documents indicate Capricor Therapeutics modified its statistical analysis plan (SAP) for the Dermamiocel BLA without prior FDA review or agreement. — Failure to agree on a statistical analysis plan with the FDA is a critical regulatory red flag that often leads to BLA rejection or severe delays.
-0.90Capricor Therapeutics is facing a securities class action lawsuit alleging investor losses between December 17, 2025, and July 26, 2026. — Class action lawsuits create legal liabilities and overhangs, though they usually follow the price drop rather than causing it.
-0.40Capricor's stock price dropped 64% to close at $7 per share on July 27, 2026, following the release of the FDA briefing documents. — This confirms a massive loss in market capitalization and a shift in investor sentiment regarding the company's valuation.
-0.20Which stocks this story touches
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The company is facing a class action lawsuit and experienced a 64% stock price drop due to FDA briefing document issues.
The company is mentioned in the context of a securities fraud class action deadline.
The company is mentioned in the context of a securities class action deadline.
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