Key Takeaways:
Capricor Therapeutics shares plunged 64 percent, and a securities fraud class action now targets the biotech over FDA concerns about Deramiocel trial data.
"Investors have until September 28, 2026 to ask the court to be appointed to lead the case," Bleichmar Fonti & Auld LLP, the firm that announced the lawsuit, said.
The complaint, filed in the U.S. District Court for the Southern District of California as Nkamga v. Capricor Therapeutics Inc., No. 26-cv-04385, covers purchases between December 17, 2025 and July 26, 2026. It alleges Capricor changed the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel, its cell therapy for Duchenne muscular dystrophy, without FDA agreement before resubmitting its Biologics License Application. The FDA had issued a Complete Response Letter in July 2025 saying the application lacked substantial evidence of effectiveness and requested additional clinical data.
On July 27, 2026, FDA briefing documents ahead of an advisory committee meeting raised concerns about post-hoc changes to the statistical analysis plan, including the methodology for the primary endpoint PUL 2.0. According to the documents, the final version of the plan was not submitted to the FDA for review before the BLA submission and was not agreed upon. Capricor shares fell $12.70, or 64.5 percent, to $7.00 that day. Two days later the advisory committee voted 9-3 that available evidence did not support Deramiocel's efficacy for DMD-associated cardiomyopathy, and the stock dropped another $2.38, or 36 percent, to $4.19 on July 30.
The lawsuit asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5. The FDA identified changes to endpoint definitions, analytical methods, and data-imputation strategies, and considered analyses based on post-study versions of the plan to be exploratory. Capricor has disputed the FDA's characterization of the statistical analysis plan materials, saying it engaged fully and transparently with the agency.
Capricor is a biotechnology company focused on cell and exosome-based therapeutics for rare diseases. Deramiocel, its lead candidate, is an investigational cell therapy intended to address cardiac and skeletal muscle complications associated with Duchenne muscular dystrophy.
The advisory committee's vote is non-binding, but the FDA's final decision on the Deramiocel BLA will determine whether Capricor can bring its lead candidate to market. The two-day slide left the shares down roughly 79 percent from the July 24 close of $19.70. The litigation adds to that regulatory uncertainty and could expose the company to substantial legal costs and settlement liabilities. Investors seeking lead plaintiff appointment face a September 28, 2026 deadline, with the class not yet certified.
This article is for informational purposes only and does not constitute investment advice.
