GlobeNewsWire
11 Sept 2026, 09:47 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 advisory committee voted 9-3 that available evidence does not support the efficacy of Capricor's lead candidate, Deramiocel, for treating DMD-associated cardiomyopathy. — A negative advisory committee vote on a lead product candidate is a critical failure that severely diminishes the probability of FDA approval and future revenue.
-0.90The FDA raised concerns that Capricor made post-hoc changes to its statistical analysis plan for the primary endpoint shortly before database unblinding. — Allegations of manipulating data analysis plans to achieve significance undermine the integrity of clinical trials and trigger regulatory distrust.
-0.70Capricor Therapeutics is facing a securities fraud class action lawsuit alleging misstatements regarding Deramiocel and its clinical data integrity. — While the stock has already plummeted, a fraud lawsuit introduces long-term legal liabilities and management distraction.
-0.40Continue reading
5 related stories
Search tags
Which stocks this story touches
The company is facing a securities fraud class action lawsuit following a massive stock drop and FDA concerns over clinical data integrity.
Free · No account
Get a free daily PDF briefing — the last 24 hours of news, with summaries and the market-impact score for each story, delivered an hour before the open.
We’ll watch
Pre-filled from this story — remove any you don’t want. Add more tickers & tags or fine-tune your watchlist anytime — every email has an edit link, no account needed.
Free forever · one email a day, max · unsubscribe in one click.How it works
PRNewsWire
5h ago
