Capricor Therapeutics, Inc. faces a federal securities class action and outreach from multiple law firms, including Glancy Prongay Wolke & Rotter LLP, over alleged failures to disclose changes to Deramiocel’s pre-specified statistical analysis plan and that the FDA had not agreed to those changes before the Biologics License Application resubmission. The alleged class period runs from Dec. 17, 2025, through July 26, 2026. Lead-plaintiff deadlines have been cited as Sept. 28, 2026, and Sept. 29, 2026. FDA briefing documents on July 27 criticized Capricor’s endpoint conversion methodology and said Deramiocel’s benefit-risk assessment appeared unfavorable without evidence of effectiveness; Cantor Fitzgerald’s Kristen Kluska called the documents an “ugly picture.” Shares fell as much as $12.29, or 62.39%, intraday and closed down $12.70, or about 64%, at $7.00. After a non-binding 9-3 advisory vote on July 29 that Medscape said relied on SAP version 1.1, the stock fell another $2.38, or 36%, to $4.19 on July 30. The allegations have not been proven in court.