Capricor Therapeutics faces a securities fraud class action in the U.S. District Court for the Southern District of California over alleged misstatements about Deramiocel and the clinical data supporting its Biologics License Application. The complaint alleges Capricor adopted changes to its pre-specified statistical analysis plan without FDA agreement before resubmitting the BLA, including methodology used to calculate the primary endpoint, PUL 2.0. FDA briefing documents released July 27, 2026, raised concerns about post-hoc changes made shortly before the database was unlocked and unblinded and said Deramiocel’s benefit-risk profile appeared unfavorable without evidence of effectiveness. Capricor shares fell $12.70, or 64.5%, from a July 24 close of $19.70 to $7.00 on July 27, with another account recording an intraday decline as steep as $12.29, or 62.39%. After a non-binding 9-3 advisory committee vote against efficacy, the stock dropped another $2.38, or 36%, to $4.19 on July 30. Investors have until September 28, 2026, to seek lead plaintiff status.