The legal dispute centers on Capricor’s Biologics License Application for deramiocel. While the company initially claimed to have addressed FDA concerns after a 2025 rejection, internal briefing documents released in July 2026 revealed that Capricor had modified its statistical analysis plan without prior agency agreement. Regulators identified these changes as post-hoc and exploratory, casting significant doubt on the therapy's benefit-risk profile.
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Investors Target Capricor Therapeutics in Securities Class Action
A federal class action lawsuit now targets Capricor Therapeutics following allegations that the company misled investors regarding the efficacy of its Duchenne muscular dystrophy treatment, deramiocel. The litigation, filed by Pomerantz LLP, addresses a precipitous stock decline triggered by regulatory scrutiny over the company's statistical analysis methods.
Market reaction to these disclosures was severe. Capricor shares plummeted 64% on July 27, 2026, following the FDA’s report, and shed an additional 36% on July 30 after an advisory committee voted 9-3 that the existing evidence failed to support the drug's efficacy. Investors who purchased securities during the defined class period have until September 28, 2026, to petition the court for lead plaintiff status.
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