CAPR INVESTIGATION: Block & Leviton Seeks to Speak With Capricor Therapeutics Investors

Boston, Massachusetts--(Newsfile Corp. - July 31, 2026) - Block & Leviton is investigating Capricor Therapeutics (NASDAQ: CAPR) for potential securities law violations. Investors who have lost money in their Capricor Therapeutics investment should contact the firm to learn more about how they might recover those losses. For more details, visit https://blockleviton.com/cases/capr.

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.