CAPR Alert: Capricor Therapeutics, Inc. (NASDAQ: CAPR) Investors Urged to Contact Hagens Berman; Investigation Opened Following Massive Stock Crash

Hagens Berman encourages investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) who suffered substantial losses to submit your losses now. The national investor rights firm has opened an investigation into whether Capricor misled investors about the efficacy and trial results of its lead product candidate, Deramiocel, intended for the treatment of Duchenne muscular dystrophy (DMD).

The investigation focuses on disclosures that emerged on July 27, 2026, when Capricor shares plummeted roughly 40% to 64% following the U.S. Food and Drug Administration's (FDA) publication of its briefing document ahead of the advisory committee meeting for Deramiocel’s biologics license application (BLA). The sharp drop was triggered by potential discrepancies between how Capricor characterized its Phase 3 HOPE-3 trial results and the FDA's analytical findings regarding the data and trial parameters.

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 pre-specified 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 the extent to which Capricor disclosed SAP modifications and their implications for the BLA,” said Reed Kathrein , the Hagens Berman partner leading the firm’s investigation. If you invested in Capricor and have substantial losses, or have knowledge that will assist the firm’s investigation, submit your losses now.