PHILADELPHIA, Aug. 24, 2026 /PRNewswire/ — National plaintiffs’ law firm Berger Montague PC announces a class action lawsuit against Capricor Therapeutics, Inc. (NASDAQ: CAPR) (“Capricor” or the “Company”) on behalf of investors who purchased or acquired Capricor securities during the period from December 17, 2025 through July 26, 2026 (the “Class Period”).
Investor Deadline: Investors who purchased or acquired Capricor securities during the Class Period may, no later than September 28, 2026, seek to be appointed as a lead plaintiff representative of the class. To learn your rights, CLICK HERE.
Headquartered in San Diego, Capricor is a clinical stage biotechnology company whose lead product candidate is Deramiocel, a cell therapy intended to treat patients suffering from Duchenne’s muscular dystrophy.
As the lawsuit alleges, on July 27, 2026, before the market opened, the U.S. Food and Drug Administration (“FDA”) released briefing documents ahead of its July 29 advisory committee (“AdCom”) meeting for the biologics license application (“BLA”) for Deramiocel. According to the briefing documents, Capricor made changes to the pre-specified statistical analysis plan (“SAP”), and the final version “was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.”
The FDA disagreed with the changes made to the SAP, stating that the “FDA does not consider the conversion of raw change to percent change and then back to raw change to have been scientifically justified, as it adds complexity and reduces accuracy.” As a result, the FDA stated that it “considers [Capricor’s] analyses based on the post-study SAP versions to be post-hoc and exploratory.” According to the briefing documents, “the benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness.“
On this news, Capricor shares fell $12.70 per share, or 64%, to close at $7.00 per share on July 27, 2026.
If you are a CAPRICOR investor and would like to learn more about this action, CLICK HERE or please contact Berger Montague: Andrew Abramowitz at aabramowitz@bergermontague.com or (215) 875-3015, or Caitlin Adorni at cadorni@bergermontague.com or (267) 764-4865.
About Berger Montague
Berger Montague is one of the nation’s preeminent law firms focusing on complex civil litigation, class actions, and mass torts in federal and state courts throughout the United States. With more than $2.4 billion in 2025 post-trial judgments alone, the Firm is a leader in the fields of complex litigation, antitrust, consumer protection, defective products, environmental law, employment law, securities, and whistleblower cases, among many other practice areas. For over 55 years, Berger Montague has played leading roles in precedent-setting cases and has recovered over $50 billion for its clients and the classes they have represented. Berger Montague is headquartered in Philadelphia and has offices in Chicago; Malvern, PA; Minneapolis; San Diego; San Francisco; Toronto, Canada; Washington, D.C., and Wilmington, DE.
For more information or to discuss your rights, please contact:
Andrew Abramowitz
Berger Montague
(215) 875-3015
aabramowitz@bergermontague.com
Caitlin Adorni
Berger Montague
(267) 764-4865
cadorni@bergermontague.com
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SOURCE Berger Montague
