Capricor sued for securities fraud after 64% stock collapse on FDA data

Capricor Therapeutics faces a securities fraud class action after its shares plunged 64 percent to $7 on FDA concerns over Deramiocel trial data.

"We're focused on investors' losses and uncovering the full scope of how management characterized these trial endpoints and undisclosed modification," Reed Kathrein, the Hagens Berman partner leading the firm's investigation, said.

The lawsuit, filed by Bleichmar Fonti & Auld LLP in the U.S. District Court for the Southern District of California, alleges Capricor and senior executives made false statements about the clinical data and regulatory path for Deramiocel, its cell therapy for Duchenne muscular dystrophy. The FDA's July 27 briefing document said the Phase 3 HOPE-3 study "did not meet its pre-specified primary and secondary efficacy endpoints," and that changes to the statistical analysis plan generated at least two additional versions covering endpoint definitions, analytical methods and data imputation. The company had touted "positive topline results" on Dec. 3, 2025, sending shares up 370 percent, before raising about $150 million in a public offering of 6 million shares at $25 each.

The stock has since fallen further, to $4.19, after an FDA advisory panel voted 9-3 on July 29 that evidence did not support Deramiocel's efficacy for DMD-associated cardiomyopathy. Investors who bought between Dec. 17, 2025 and July 26, 2026 have until Sept. 28, 2026 to seek lead plaintiff status.

Capricor submitted its Biologics License Application for Deramiocel in late 2024. The FDA issued a Complete Response Letter in July 2025, saying the application lacked substantial evidence of effectiveness and required additional clinical data. The complaint alleges Capricor failed to disclose that it adopted changes to the pre-specified statistical analysis plan without FDA agreement before resubmitting the BLA.

Hagens Berman has filed a separate action on behalf of investors, and both firms are seeking lead plaintiff appointment. BFA said it has recovered more than $900 million from Tesla's board and $420 million from Teva Pharmaceutical in prior actions.

The litigation adds legal and financial pressure to a company whose lead asset now faces an uncertain approval path. Investors will watch the FDA's final decision on the Deramiocel BLA and any settlement or dismissal motions in the coming months.

This article is for informational purposes only and does not constitute investment advice.