Newsfile Corp
02 Sept 2026, 19:35 UTC · 2h 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
4 claims · each scored for market impact
An FDA advisory committee voted 9-3 that available evidence does not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy. — A negative advisory committee vote on a lead product candidate is a primary driver of failure for biotech firms and severely limits approval prospects.
-1.00The FDA stated that the benefit-risk assessment for Deramiocel appeared unfavorable due to a lack of evidence of effectiveness. — Direct FDA skepticism regarding the benefit-risk profile typically signals a high probability of a final BLA rejection.
-0.90The FDA identified that Capricor made changes to its statistical analysis plan (SAP) that were not submitted for review or agreed upon prior to the BLA submission. — Allegations of improper data analysis (post-hoc/exploratory) undermine the scientific credibility of the trial results.
-0.70Continue reading
6 related stories
Search tags
A securities class action lawsuit has been filed against Capricor Therapeutics alleging the company misled investors regarding the path to FDA approval. — Litigation creates additional financial liability and management distraction, though it is a lagging indicator of the clinical failure.
-0.40Which stocks this story touches
The company is facing a securities class action lawsuit following a massive stock price drop and negative FDA feedback regarding its lead product candidate.
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
How the impact breaks down
Where the story's weight lands
Stocks most exposed
Modeled from each name's sensitivity to this story
No stock impact ranking available yet.
Newsfile Corp
2h ago
