Capricor Therapeutics, Inc. (NASDAQ: CAPR) Securities Fraud Class Action

The Capricor Therapeutics, Inc. class action lawsuit was filed on behalf of those who purchased or otherwise acquired Capricor Therapeutics, Inc. (“Capricor”) (NASDAQ: CAPR) securities between December 17, 2026 and July 26, 2026, inclusive (the “Class Period”). Captioned Darren Ngasseu Nkamga v. Capricor Therapeutics, Inc., No. 26-cv-04385 (S.D. Cal.), the Capricor class action lawsuit alleges that Capricor and/or certain of its officers and/or directors violated federal securities laws by making false or misleading statements and/or omitted to disclose material information.

If you lost money as a result of your Capricor investment and want to find out more about this action and your rights, fill out the form on this page or contact attorney Jonathan Naji, Esq. of KTMC by calling (484) 270-1453 or via e-mail at [email protected]. 

COMPLAINT ALLEGATION SUMMARY:
Capricor is a biotechnology company focused on the development of cell and exosome-based therapeutics for the treatment of 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 complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material facts about the company’s business, operations, and prospects. Specifically, Defendants misrepresented and/or failed to disclose that: (1) Capricor had adopted changes to the pre-specified statistical analysis plan used to analyze Deramiocel clinical data; (2) the FDA had not agreed to these changes prior to Capricor resubmitting the Biologics License Application (“BLA”); (3) the absence of agreement created significant risk that the FDA could conclude that the clinical results of Deramiocel did not provide substantial evidence of its effectiveness and risking its chances for approval; and (4) as a result of the foregoing, Defendants’ statements about the company’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.

WHY DID CAPRICOR’S STOCK DROP?
On July 27, 2026, the FDA released briefing documents ahead of its July 29 advisory committee meeting for Deramiocel’s BLA. The briefing documents revealed that Capricor had made changes to the pre-specified statistical analysis plan and failed to submit the final version to the FDA for review “prior to BLA submission and was not discussed and consequently not agreed upon.” The FDA went on to disagree with the changes, 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.” The briefing documents continued, detailing that “the benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness.” On this news, the price of Capricor stock fell 64%.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP:
Kessler Topaz Meltzer & Check, LLP (KTMC) is a leading U.S. plaintiff-side law firm focused on securities-fraud class actions and global investor protection. The firm represents individual investors as well as institutions, such as major pension funds, asset managers, and international investors. KTMC has led some of the largest recoveries in securities litigation and has been recognized by peers and the legal media with numerous accolades, including being recognized in Chambers & Partners USA 2026 as a Band 1 Top Firm in Securities and Class Actions, Legal 500’s Tier 1 Rankings for Securities and M&A Litigation, The National Law Journal’s Plaintiff’s Hot List and Trailblazers in Plaintiffs’ Law, BTI Consulting Group’s Honor Roll of Most Feared Law Firms, The Legal Intelligencer’s Class Action Firm of the Year, Lawdragon’s Leading Plaintiff Financial Lawyers, and Law360’s Titans of the Plaintiffs Bar. The firm operates globally with offices in Pennsylvania and California. KTMC has recovered over $25 billion for our clients and the classes they represent.