CAPR INVESTOR DEADLINE: Capricor Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Shareholder Class Action Lawsuit

A securities fraud class action lawsuit has been filed against Capricor, and investors are encouraged to submit their losses now. A securities fraud class action lawsuit has been filed against Capricor, and investors are encouraged to submit their losses now. A securities fraud class action lawsuit has been filed against Capricor, and investors are encouraged to submit their losses now.

The lawsuit alleges that Capricor and certain executives made materially false and misleading statements regarding the clinical trial data and regulatory pathway for its lead product candidate, Deramiocel, intended to treat Duchenne muscular dystrophy (DMD). Specifically, defendants allegedly failed to disclose that they adopted changes to the pre-specified statistical analysis plan (SAP) without agreement from the U.S. Food and Drug Administration (FDA) prior to resubmitting its Biologics License Application (BLA).

On December 3, 2025 Capricor announced "Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy." The company's CEO said "HOPE-3 delivered strong and definitive evidence that Deramiocel can meaningfully improve the course of Duchenne muscular dystrophy, demonstrating statistically significant improvements in both skeletal and cardiac function." In response, the market sent the price of Capricor shares up $23.60, or 370% higher on December 3, 2025. The next day, the company launched a proposed public offering of its shares which included about 6 million shares priced at $25 per share.

Capricor's assurances about its Deramiocel "strong and definitive evidence" came into question on July 27, 2026. That day, the FDA published its briefing report for the July 29, 2026 meeting being held to consider Capricor's resubmitted BLA for Deramiocel. The brief focused in large part on Capricor's statistical analysis plan ("SAP"), which governed how clinical trial data is analyzed to determine if a drug has met its predefined efficacy and safety endpoints. In contrast to Capricor's December claims, the FDA said in the brief that the HOPE-3 study "did not meet its pre-specified primary and secondary efficacy endpoints showing no statistically significant difference between deramiocel and placebo at 12 months." The FDA also said, "changes were made to the pre-specified [SAP], generating at least 2 additional versions[,]", and "[t]hose changes included modifications to the primary and key secondary endpoint definitions; the analytical methods; and the data imputation for certain intercurrent events." The market quickly digested the news, sending the price of Capricor shares down about 64% to close at $7 on July 27.

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

If you purchased or acquired Capricor securities between December 17, 2025, and July 26, 2026, and suffered significant financial losses, you have until September 28, 2026, to ask the court to appoint you as lead plaintiff. You do not need to seek lead plaintiff status to share in any potential recovery. To learn more about your legal options, submit your information to Hagens Berman, visit www.hbsslaw.com/investor- fraud /capr, call Reed Kathrein at 844-916-0895, or email [email protected].