A securities fraud class action against Capricor Therapeutics, Inc. and certain senior executives is now pending in the U.S. District Court for the Southern District of California, and investors have until September 28, 2026 to ask the court to appoint a lead plaintiff. The case, Nkamga v. Capricor Therapeutics, Inc. et al., No. 26-cv-04385, centers on disclosures tied to the company’s Deramiocel program and the FDA review that followed.
Bleichmar Fonti & Auld LLP said the complaint seeks to represent investors in Capricor securities under Sections 10(b) and 20(a) of the Exchange Act of 1934. That filing matters now because the deadline is fixed, not abstract: anyone seeking to guide the case must move by Sept. 28, 2026, or step aside while the lawsuit proceeds without them.
Capricor is a biotechnology company focused on cell and exosome-based therapeutics for rare diseases. Deramiocel is its investigational cell therapy for Duchenne muscular dystrophy, and the company submitted a Biologics License Application to the FDA in late 2024. The FDA issued a Complete Response Letter in July 2025 saying the application did not meet the statutory requirement for substantial evidence of effectiveness and that additional clinical data was needed.
The complaint alleges Capricor did not disclose that it had adopted changes to the pre-specified statistical analysis plan used to analyze Deramiocel data and that the FDA had not agreed to those changes before the Deramiocel BLA was resubmitted. That issue became more visible on July 27, 2026, when the FDA released briefing documents before an advisory committee meeting and reportedly raised concerns about post-hoc changes to the analysis plan and the method used to calculate the primary endpoint, PUL 2.0, shortly before the database was unlocked and unblinded.
The market reaction was severe. Capricor stock fell $12.70 a share, or 64.5%, from a closing price of $19.70 on July 24, 2026 to $7.00 on July 27, 2026. After the FDA advisory committee met on July 29, 2026, Medscape reported the panel voted 9-3 in a non-binding decision and concluded that available evidence did not support Deramiocel’s efficacy for DMD-associated cardiomyopathy. Shares then dropped another $2.38, or 36%, from $6.57 on July 29 to $4.19 on July 30.
The lawsuit is built on the gap between what investors were told and what the FDA later appeared to question. Whether the court gives the lead plaintiff role to an investor before the September 28 deadline will determine who drives that challenge, and who controls the next phase of a case that has already erased most of the stock’s value in two sharp moves.
