PRNewsWire
20 Aug 2026, 14:00 UTC · 1d ago
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An FDA advisory committee voted 9-3 that available evidence does not support the efficacy of deramiocel for treating DMD-associated cardiomyopathy. — Negative AdCom votes for a primary drug candidate significantly increase the likelihood of FDA rejection, erasing the company's core value proposition.
-0.90The FDA stated 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 benefit-risk profile is a critical failure for a biotech company.
-0.80The FDA characterized Capricor's statistical analyses as 'post-hoc and exploratory' because the statistical analysis plan was modified without FDA agreement just before data unblinding. — Accusations of manipulating statistical plans to find favorable results undermine the scientific integrity of the data and the company's credibility.
-0.70Continue reading
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Pomerantz LLP has filed a class action lawsuit against Capricor Therapeutics alleging securities fraud and unlawful business practices. — Legal actions create additional financial liability and management distraction, though they usually follow the primary catalyst of price decline.
-0.40Which stocks this story touches
The company is facing a class action lawsuit following an unfavorable FDA benefit-risk assessment and a massive stock price collapse.
The company is the subject of a class action lawsuit filed by Pomerantz LLP.
The company is under investigation by Pomerantz LLP regarding claims on behalf of investors.
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