Capricor Therapeutics, Inc. Class Action Lawsuit - CAPR
Case Summary
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The Capricor class action lawsuit seeks to represent purchasers or acquirers of Capricor Therapeutics, Inc. (NASDAQ: CAPR) securities between December 17, 2025 and July 26, 2026, inclusive (the “Class Period”). Captioned Nkamga v. Capricor Therapeutics, Inc., No. 26-cv-04385 (S.D. Cal.), the Capricor class action lawsuit charges Capricor and certain of Capricor’s top executives with violations of the Securities Exchange Act of 1934.
If you suffered substantial losses and wish to serve as lead plaintiff of the Capricor class action lawsuit, please provide your information in the form on this page. You can also contact attorneys Ken Dolitsky or Michael Albert of Robbins Geller by calling 800/851-7783 or via e-mail at info@rgrdlaw.com. Lead plaintiff motions for the Capricor class action lawsuit must be filed with the court no later than September 29, 2026.
CASE ALLEGATIONS: Capricor is a biotechnology company focused on the development of cell and exosome-based therapeutics for the treatment of Duchenne muscular dystrophy, a rare genetic disorder characterized by progressive muscle degeneration and premature death. Its lead product candidate is Deramiocel, a cell therapy to address cardiac and skeletal muscle complications associated with Duchenne muscular dystrophy.
The Capricor class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) Capricor adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel; (ii) the FDA had not agreed to those changes before Capricor resubmitted the Deramiocel Biologics License Application (“BLA”); (iii) as a result, there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of effectiveness of Deramiocel; and (iv) as a result of the foregoing, there was a substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy.
On July 27, 2026, before the market opened, the FDA allegedly released briefing documents ahead of its July 29 advisory committee meeting for the BLA. According to the complaint, the briefing documents explained that Capricor made changes to the pre-specified statistical analysis plan (“SAP”) and that the final version “was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.” The final version of the statistical analysis plan was allegedly created one day before the data was unblinded, and the FDA commented 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.” The FDA allegedly further stated that it “considers [Capricor’s] analyses based on the post-study SAP versions to be post-hoc and exploratory.” The complaint further alleges that the briefing documents concluded “the benefit-risk assessment for [D]eramiocel appears unfavorable in the absence of evidence of effectiveness.”
That same day, Capricor allegedly provided “an update,” stating that “‘Capricor has engaged fully and transparently with the FDA throughout the review process’” and that “‘[i]t is critical to understand that the post-hoc analyses in the FDA’s briefing materials rely on SAP version 1.1, an unsigned incomplete internal draft which became obsolete with the addition of cohort B and did not include content specifically requested by the FDA.’” The Capricor class action lawsuit further alleges that Cantor Fitzgerald published an investor note that same day, stating the FDA’s “briefing documents paint an ugly picture” and “raise several concerns and make allegations about the integrity of data collecting.” On this news, the price of Capricor stock fell 64%, according to the complaint.
On July 29, 2026, the advisory committee allegedly met to discuss the Deramiocel BLA. The next day, Medscape reported that the panel relied on SAP version 1.1 as the “prespecified plan” and, in a non-binding 9-3 vote, the panel “concluded that the available evidence does not support the efficacy of deramiocel for treating DMD-associated cardiomyopathy.” On this news, the price of Capricor stock fell 36%, according to the complaint.
THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Capricor securities during the Class Period to seek appointment as lead plaintiff in the Capricor class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Capricor class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Capricor class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Capricor class action lawsuit.
ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities fraud and shareholder rights litigation. Our Firm ranked #1 on the most recent ISS Securities Class Action Services Top 50 Report, recovering more than $916 million for investors in 2025. This marks our fourth #1 ranking in the past five years. And in those five years alone, Robbins Geller recovered $8.4 billion for investors – $3.4 billion more than any other law firm. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world, and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig.