Capricor Therapeutics shares fell 64.5 percent after FDA briefing documents raised concerns about post-hoc statistical analysis changes for Deramiocel, its lead Duchenne muscular dystrophy therapy. Bleichmar Fonti & Auld LLP has filed a securities fraud class action against the company, with a September 28 deadline for investors to seek lead plaintiff status.
Capricor Therapeutics shares plunged 64.5 percent to $7.00 after FDA documents questioned the integrity of Deramiocel clinical data, prompting a securities fraud class action.
Bleichmar Fonti & Auld LLP filed the lawsuit in the U.S. District Court for the Southern District of California, alleging Capricor and senior executives violated federal securities laws by failing to disclose changes to the pre-specified statistical analysis plan for Deramiocel before resubmitting the Biologics License Application.
The stock fell $12.70 per share from a July 24 closing price of $19.70 after the FDA released briefing documents on July 27 ahead of an advisory committee meeting. The documents raised concerns about post-hoc changes to the statistical analysis plan, including modifications to the PUL 2.0 primary endpoint methodology shortly before the database was unlocked and unblinded. Two days later, the advisory committee voted 9-3 that available evidence did not support Deramiocel's efficacy for treating DMD-associated cardiomyopathy, according to Medscape. Capricor shares dropped another 36 percent to $4.19 on July 30.
Deramiocel is an investigational cell therapy for Duchenne muscular dystrophy, a rare genetic disorder that causes progressive muscle degeneration. Capricor submitted the BLA to the FDA in late 2024, and the agency issued a Complete Response Letter in July 2025 stating the application did not meet the statutory requirement for substantial evidence of effectiveness and that additional clinical data was needed.
The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in Capricor securities. The case is captioned Nkamga v. Capricor Therapeutics, Inc. et al., No. 26-cv-04385. Investors have until September 28 to ask the court to be appointed lead plaintiff. All representation is on a contingency fee basis, with shareholders not responsible for court costs or litigation expenses, according to BFA Law.
The 64 percent collapse erased most of Capricor's market value and threatens the company's path to commercialization for its lead candidate. The class action adds legal costs and management distraction on top of the regulatory setback. Investors will watch whether additional shareholders join the suit before the September 28 deadline and whether Capricor pursues further clinical studies to address the FDA's efficacy concerns.
This article is for informational purposes only and does not constitute investment advice.
