BREAKING: Capricor Therapeutics Investigated for Securities Fraud by Block & Leviton; Investors Should Contact the Firm to Learn More

Block & Leviton is investigating Capricor Therapeutics in connection with the company's representations about the regulatory path for deramiocel, its cell therapy candidate for Duchenne muscular dystrophy. Capricor had characterized its Biologics License Application as on track ahead of an August 2026 PDUFA date and pointed to positive long-term clinical data.

On July 27, 2026, the FDA released briefing documents ahead of an advisory committee meeting in which agency staff concluded the data did not provide "substantial evidence of effectiveness," noting that approval generally requires at least two adequate and well-controlled studies while deramiocel's application rested on a single pivotal trial. In a story covering the news, Stat News wrote that "[a]fter the study was completed, the FDA said, Capricor made a litany of changes to its statistical analysis plan, a crucial document outlining how a study will be measured. Revising that plan after a study is done raises concerns that a company may be looking to generate a positive outcome when there wasn’t one based on its original design." Capricor shares fell more than 60% on the news.

Anyone who purchased Capricor Therapeutics common stock and has seen their shares fall may be eligible, whether or not they have sold their investment. Investors should contact Block & Leviton to learn more.

Block & Leviton is investigating whether the Company committed securities law violations and may file an action to attempt to recover losses on behalf of investors who have lost money.

If you've lost money on your investment, you should contact Block & Leviton to learn more via our case website, by email at [email protected], or by phone at (888) 256-2510.