Lowey Dannenberg, P.C. is Investigating Capricor Therapeutics, Inc. (NASDAQ: CAPR) for Potential Violations of the Federal Securities Laws

NEW YORK, July 30, 2026 (GLOBE NEWSWIRE) -- Lowey Dannenberg P.C., a preeminent law firm in obtaining redress for consumers and investors, is investigating Capricor Therapeutics, Inc. (NASDAQ: CAPR) (“Capricor” or the “Company”) for potential violations of the federal securities laws.

On July 27, 2026, ahead of a July 29, 2026 meeting of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee convened to review Capricor’s Biologics License Application (“BLA”) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (“DMD”), Capricor disclosed that the FDA’s briefing materials relied on a superseded statistical analysis – Statistical Analysis Plan (“SAP”) version 1.1 – which the Company described as an unsigned, incomplete internal draft that predated the addition of a study cohort and omitted content the FDA had requested, rather than the final SAP version 3.0 that Capricor says governed its reported Phase 3 HOPE-3 trial results. Following this news, the price of Capricor stock fell approximately 64%, wiping out hundreds of millions of dollars in shareholder value.