CAPR 10-DAY DEADLINE ALERT: Capricor Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Shareholder Class Action Lawsuit Before September 28 Deadline

This alert follows the U.S. Food and Drug Administration's (FDA) recent decision to extend the review period for Capricor's Biologics License Application (BLA), underscoring the ongoing regulatory and disclosure scrutiny surrounding the company.

FDA Extends BLA Review Following Post-AdCom Submissions On Aug. 24, Capricor announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for Capricor's lead investigational cell therapy, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD), moving the decision date from August 22, 2026, to November 22, 2026. The agency classified Capricor's recent submission-which follows a turbulent July 2026 Advisory Committee meeting and includes 24-month open-label extension data from the Phase 3 HOPE-3 study alongside a request to pivot toward a refined indication focused solely on upper limb function-as a major amendment.

Class Period: Dec. 17, 2025 - July 26, 2026 Lead Plaintiff Deadline: Sept. 28, 2026

Core Allegations and Background Material Misleading Statements Regarding Clinical Trial Data and SAP Changes : 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).

The HOPE-3 Trial Breakthrough and Subsequent Capital Raise: 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." Driven by these claims, 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.

FDA Briefing Document Reveals SAP Changes and Triggers 64% Stock Collapse: Capricor's public assurances unraveled on July 27, 2026, when the FDA published briefing documents ahead of an Advisory Committee meeting. The documents revealed 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 roughly 64% in a single day to close at $7.00. An Advisory Committee subsequently voted 9-3 against the efficacy of the drug, compounding investor losses.

Hagens Berman's Investigation "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 Be...