CAPR INVESTOR DEADLINE: Capricor Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Shareholder Class Action Lawsuit Before September 28, 2026 Deadline

Investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) are reminded of the upcoming September 28, 2026 lead plaintiff deadline in the ongoing securities class action. This follows the U.S. Food and Drug Administration's (FDA) decision to extend the review period for Capricor's Biologics License Application (BLA), highlighting ongoing regulatory and disclosure scrutiny.

The FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for Capricor's investigational cell therapy, deramiocel, for Duchenne muscular dystrophy (DMD), moving the decision date from August 22, 2026, to November 22, 2026. The agency classified Capricor's recent submission, which includes 24-month open-label extension data from the Phase 3 HOPE-3 study and a request to focus on upper limb function, as a major amendment.

The lawsuit alleges that Capricor and certain executives made materially false and misleading statements regarding the clinical trial data and regulatory pathway for Deramiocel. Specifically, defendants allegedly failed to disclose that they adopted changes to the pre-specified statistical analysis plan (SAP) without FDA agreement prior to resubmitting its Biologics License Application (BLA).

On December 3, 2025, Capricor announced positive topline results from its pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy, stating that the study delivered strong evidence that Deramiocel can meaningfully improve skeletal and cardiac function. Following this announcement, Capricor's share price surged 370% to close up $23.60 on December 3, 2025. The following day, the company launched a public stock offering of approximately 6 million shares priced at $25 per share.

Capricor's public assurances were challenged on July 27, 2026, when the FDA published briefing documents revealing that Capricor made unagreed-upon post-hoc modifications to its pre-specified Statistical Analysis Plan (SAP). The FDA stated 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. Capricor shares crashed approximately 64% in a single day to close at $7.00. An Advisory Committee subsequently voted 9-3 against the efficacy of the drug.

Hagens Berman is focused on investors' losses and uncovering the full scope of how management characterized these trial endpoints and undisclosed modifications.