Capricor Therapeutics Faces Extended FDA Review Amid Securities Lawsuit

The regulatory delay follows an August 24 announcement from Capricor, which revealed the agency classified recent submissions as a major amendment. This move includes new data from the Phase 3 HOPE-3 study and a pivot in the proposed indication toward upper limb function, trailing a contentious July Advisory Committee meeting where members voted 9-3 against the drug's efficacy.

The class action, covering the period between December 17, 2025, and July 26, 2026, centers on allegations that Capricor executives misrepresented clinical trial data. Investors claim the company failed to disclose that it modified its pre-specified statistical analysis plan without FDA approval. These disclosures triggered a 64% collapse in share price in late July, abruptly reversing the massive gains seen after the company’s December 2025 announcement of positive topline results.