Robbins LLP Urges CAPR Stockholders to Contact the Firm for Information About the Class Action Against Capricor Therapeutics, Inc.
The lawsuit says Capricor misled investors about Deramiocel’s FDA path after briefing documents showed unagreed SAP changes and no proven efficacy.
- Investors have filed a securities class action against Capricor Therapeutics, Inc. alleging the company misled shareholders regarding the regulatory pathway for Deramiocel, a cell therapy intended to treat Duchenne muscular dystrophy.
- Capricor made unagreed-upon post-hoc modifications to its pre-specified Statistical Analysis Plan for the HOPE-3 study without FDA approval before resubmitting the Biologics License Application .
- The FDA stated the HOPE-3 study "did not meet its pre-specified primary and secondary efficacy endpoints showing no statistically significant difference between deramiocel and placebo at 12 months." Following these July 27, 2026 disclosures, Capricor shares crashed 64% to close at $7.00.
- Law firms Hagens Berman and Robbins LLP are representing investors in the litigation, with Hagens Berman partner Reed Kathrein stating they are "focused on investors' losses and uncovering the full scope of how management characterized these trial endpoints and undisclosed modification."
- Capricor faces ongoing regulatory uncertainty after skipping analyst Q&A during its Q2 2026 earnings call, citing sensitivity of FDA discussions. Investors seeking lead plaintiff status must move the court no later than September 28, 2026.
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12 Articles
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