SAN DIEGO, CA – August 13, 2026 (STL.News) Capricor Therapeutics, Inc. (NASDAQ: CAPR) is facing a new federal securities class action alleging that the biotechnology company and its leadership made materially false or misleading statements concerning the regulatory prospects for deramiocel, its investigational cell therapy for Duchenne muscular dystrophy.
The lawsuit, Nkamga v. Capricor Therapeutics, Inc., et al., Case No. 3:26-cv-04385, was filed in the U.S. District Court for the Southern District of California on behalf of investors who purchased or otherwise acquired Capricor securities between Dec. 17, 2025, and July 26, 2026, inclusive.
Importantly, the law firm that filed the original lawsuit in this current matter was Glancy Prongay Wolke & Rotter LLP, or GPWR. The firm’s July 30 announcement states that it filed the class action on behalf of Capricor investors. Court docket information identifies investor Darren Ngasseu Nkamga as the named plaintiff and shows that he is represented by attorneys from Glancy Prongay Wolke & Rotter.
Since that initial filing, numerous other securities law firms have issued notices concerning the case, sought potential lead plaintiffs or announced investigations related to Capricor.
Investors currently have until Sept. 28, 2026, to ask the court to appoint them lead plaintiff in the action, according to multiple notices, including an Aug. 13 announcement from Rosen Law Firm.
Glancy Prongay Wolke & Rotter Filed Lawsuit
The distinction between the firm that filed the case and firms subsequently advertising the case to investors is significant.
Glancy Prongay Wolke & Rotter announced July 30 that it had filed Nkamga v. Capricor Therapeutics, Inc., et al. The lawsuit seeks to represent investors who acquired Capricor securities during the Dec. 17, 2025-July 26, 2026 class period. The plaintiff asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
The federal docket identifies Nkamga as the plaintiff and Capricor Therapeutics and its Chief Executive Officer, Linda Marbán, as defendants.
The lawsuit remains in its early stages. Its allegations have not been proven, no class has been certified, and the filing of the complaint does not constitute a finding that Capricor or any individual defendant violated federal securities laws.
Lawsuit Centers on Deramiocel Disclosures
At the heart of the dispute is Deramiocel, formerly known as CAP-1002, Capricor’s investigational cell therapy being developed for patients with Duchenne muscular dystrophy, or DMD.
Duchenne muscular dystrophy is a serious genetic disease characterized by progressive muscle degeneration and weakness. Deramiocel is an allogeneic cell therapy manufactured using donor heart tissue.
Capricor has devoted substantial resources to developing Deramiocel and pursuing U.S. Food and Drug Administration approval.
According to allegations described in the Rosen Law Firm notice, the defendants failed to adequately disclose that Capricor had changed the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel, and that the FDA had not agreed to those changes before Capricor resubmitted its Biologics License Application.
The complaint further alleges that these circumstances created a significant risk that the FDA could determine that the clinical results failed to provide substantial evidence of Deramiocel’s effectiveness, thereby jeopardizing regulatory approval.
Those assertions are allegations contained in the litigation and should not be interpreted as established facts or findings by the court.
FDA Documents Triggered Sharp CAPR Selloff
The litigation followed a dramatic change in investor expectations surrounding deramiocel.
On July 27, 2026, the FDA released briefing materials ahead of a July 29 advisory committee meeting concerning Capricor’s Biologics License Application.
The materials raised questions about whether the company’s submitted evidence was sufficient to demonstrate effectiveness.
Capricor shares subsequently declined sharply as investors reassessed the likelihood of regulatory approval. The selloff wiped out a substantial portion of the company’s market value and became the central loss event cited in shareholder litigation and law-firm investigations.
The regulatory concerns did not end with the release of the briefing documents.
On July 29, an FDA advisory panel concluded that Capricor had not definitively demonstrated that its experimental therapy benefits patients with heart-related complications from Duchenne muscular dystrophy.
For a biotechnology company whose valuation is heavily influenced by the prospects of a key experimental therapy, developments at the FDA can cause unusually large changes in share price.
What the Capricor Lawsuit Alleges
The current complaint alleges, among other things, that investors were not adequately informed about regulatory risks associated with the deramiocel application.
According to descriptions of the complaint, the plaintiff alleges that defendants made materially false or misleading statements or failed to disclose information concerning:
- Changes allegedly made to the pre-specified statistical analysis plan for deramiocel clinical data.
- The allegation that the FDA had not agreed to those changes before the company resubmitted the BLA.
- The risk that regulators could determine the clinical evidence did not provide substantial evidence of effectiveness.
- The resulting risk to FDA approval of deramiocel for Duchenne muscular dystrophy.
- Whether positive statements concerning Capricor’s business, operations, and prospects had a reasonable basis.
The plaintiff claims investors suffered damages when information concerning those issues became known to the market.
Capricor and the individual defendants will have the opportunity to contest the allegations and present their defenses as the litigation proceeds.
Multiple Law Firms Focus on Capricor Investors
A growing number of shareholder-rights firms have publicized the litigation or related investigations since Capricor’s stock decline.
Among the firms that have issued notices or are examining potential claims involving CAPR investors are:
- Glancy Prongay Wolke & Rotter LLP — filed the current Nkamga securities class action in federal court.
- Rosen Law Firm — issued an Aug. 13 notice concerning the pending class action and Sept. 28 lead plaintiff deadline.
- Hagens Berman Sobol Shapiro LLP — has announced an investigation into Capricor following the July 27 disclosures and stock decline.
- Block & Leviton LLP — announced an investigation into potential securities law violations involving Capricor.
- Bleichmar Fonti & Auld LLP has announced an investigation into potential securities fraud claims involving Capricor investors.
- Kirby McInerney LLP — has previously issued Capricor investor notices and is active in shareholder securities litigation involving the company.
- Bernstein Liebhard LLP — has issued investor-related notices concerning securities class actions.
- Law Offices of Frank R. Cruz — has been active in investigating potential shareholder claims.
- Holzer & Holzer LLC — has publicized securities investigations on behalf of investors.
- Law Offices of Howard G. Smith — has issued notices involving potential securities claims by shareholders.
Investors should understand that the existence of multiple law-firm notices does not mean multiple independent lawsuits necessarily have been filed over the same allegations. Firms frequently announce investigations or solicit potential clients after a securities class action has already been filed.
In this instance, Glancy Prongay Wolke & Rotter is the firm identified as having filed the original Nkamga complaint underlying the current Dec. 17, 2025-July 26, 2026 class period.
An Earlier Capricor Securities Case Is Separate
Capricor has also faced an earlier securities class action, and the two matters should not be confused.
Capricor disclosed in a regulatory filing that, on July 17, 2025, a putative securities class action was filed in the Southern District of California naming Capricor and its CEO, Linda Marbán, as defendants. That earlier action alleged violations of federal securities laws and sought unspecified damages.
Law-firm notices concerning that earlier litigation identify a class period running from Oct. 9, 2024 through July 10, 2025.
That is distinct from the newly filed Nkamga action, which concerns investors who acquired CAPR securities from Dec. 17, 2025 through July 26, 2026.
Keeping those cases separate is important because the alleged misconduct, class periods, market events, and procedural deadlines differ.
September 28 Lead Plaintiff Deadline
Investors covered by the current Nkamga lawsuit have until Sept. 28, 2026, to move the court for appointment as lead plaintiff, according to the Rosen and GPWR notices.
The lead plaintiff generally represents the proposed investor class and works with court-appointed lead counsel to direct the litigation.
An investor does not necessarily have to become lead plaintiff to potentially participate in a future recovery. Rosen’s notice states that investors may retain counsel of their choosing or remain absent members of the proposed class, and that no class has yet been certified.
There is also no guarantee that the litigation will produce a settlement or judgment for shareholders.
Capricor’s Regulatory Story Remains Central
Beyond the shareholder litigation, the underlying FDA process surrounding deramiocel remains particularly important to Capricor.
The company describes itself as a biotechnology company focused on developing transformative cell- and exosome-based therapeutics, with Duchenne muscular dystrophy representing a major focus of its development program.
The FDA’s concerns and subsequent advisory committee review therefore represented far more than a routine regulatory development. They affected expectations surrounding one of the company’s most important potential products and prompted a rapid reassessment of CAPR’s valuation by investors.
The securities case will now examine a different question: whether investors received materially accurate and complete information about those regulatory risks during the alleged class period.
That question will ultimately be determined through the federal court process, not through the allegations contained in shareholder law-firm announcements.
For CAPR shareholders, the immediate procedural date to watch is Sept. 28, 2026, the deadline currently identified for investors seeking appointment as lead plaintiff in the newly filed class action.
Disclaimer: This article is for news and informational purposes only and does not constitute legal or investment advice. The claims described in the securities lawsuit are allegations that have not been proven. Capricor Therapeutics and the individual defendants are presumed not liable unless liability is established through the judicial process. No class has been certified, and there has been no court determination that the defendants violated federal securities laws.
