SAN DIEGO, CA – September 10, 2026 (STL.News) Aardvark Therapeutics, Inc. (NASDAQ: AARD) is facing a federal securities class action lawsuit alleging that investors were misled about the safety and development prospects of its lead drug candidate, ARD-101, before clinical setbacks sent the biotechnology company’s shares sharply lower.
The litigation comes as several securities law firms are notifying Aardvark investors of an Oct. 13, 2026, deadline to seek appointment as lead plaintiff.
The class action was filed in the U.S. District Court for the Southern District of California and is docketed as 26-cv-04643. According to litigation notices, the action seeks to represent investors who purchased Aardvark common stock pursuant to or traceable to offering documents connected with the company’s February 2025 initial public offering and/or investors who acquired Aardvark securities between Feb. 13, 2025, and May 14, 2026, inclusive.
The lawsuit asserts claims under the Securities Act of 1933 and the Securities Exchange Act of 1934.
Importantly, the allegations contained in the complaint have not been proven. The filing of a securities class action does not establish that Aardvark Therapeutics or any individual defendant violated federal securities laws, and there has been no court determination of liability based on the information reviewed for this report.
Aardvark’s $16 IPO
Aardvark Therapeutics is a clinical-stage biopharmaceutical company developing small-molecule therapies targeting metabolic diseases.
The company completed its IPO in February 2025 at $16 per share. According to Aardvark’s subsequent SEC filings, it sold approximately 6.12 million shares, including shares purchased through the underwriters’ option, and received approximately $87.5 million in net proceeds.
The securities complaint focuses heavily on statements surrounding Aardvark’s lead product candidate, ARD-101.
ARD-101 has been developed as a potential treatment for hyperphagia associated with Prader-Willi syndrome, or PWS, a rare genetic disorder. Hyperphagia involves excessive, persistent hunger and is one of the most challenging characteristics of PWS.
Aardvark had advanced ARD-101 into its Phase 3 Hunger Elimination or Reduction Objective, or HERO, trial, along with an open-label extension trial.
According to the complaint summarized by Pomerantz LLP, investors allege that Aardvark and certain officers and directors made materially false or misleading statements or failed to disclose material information concerning ARD-101.
Specifically, plaintiffs allege that ARD-101 was less safe than investors were led to believe and that its clinical, regulatory, and commercial prospects were consequently overstated. The lawsuit further alleges that statements made in the company’s IPO offering documents and during the class period were materially false or misleading.
Those are plaintiffs’ allegations and remain subject to litigation.
February 2026 clinical trial pause
A major turning point occurred on Feb. 27, 2026, when Aardvark voluntarily paused enrollment and dosing in clinical trials after safety monitoring identified cardiac observations.
Aardvark later confirmed in its SEC filings that it voluntarily paused enrollment and dosing in the HERO and open-label extension trials involving ARD-101, as well as the POWER and STRENGTH trials involving ARD-201, following what the company characterized as reversible cardiac observations in a healthy-volunteer study.
The development dramatically affected Aardvark’s stock.
Hagens Berman says AARD shares fell by more than 56% following the February announcement.
That decline matters to the securities litigation because plaintiffs are trying to connect the company’s earlier public statements about ARD-101 with the later disclosure of the cardiac observations and the resulting loss in market value.
FDA imposes full clinical hold
The situation escalated again in May.
On May 14, 2026, Aardvark formally disclosed to the Securities and Exchange Commission that the U.S. Food and Drug Administration had placed a full clinical hold on the investigational new drug application for ARD-101.
Unlike the allegations in the lawsuit, Aardvark’s SEC filing independently confirms the FDA clinical hold.
The company said the clinical hold applied to all ongoing clinical studies under the ARD-101 investigational new drug application, including the Phase 3 HERO trial and the Phase 3 open-label extension trial.
At the time, Aardvark said it remained in active discussions with the FDA to resolve the hold and determine a potential path forward for the ARD-101 program.
Hagens Berman reports that Aardvark shares subsequently declined another 32.1% after the FDA action was disclosed.
The February and May developments form key components of the investors’ theory of the case.
HERO trial subsequently terminated
Another significant development has occurred since the end of the proposed class period.
Aardvark disclosed that in June 2026 it terminated both the HERO and open-label extension trials and does not currently intend to resume those trials in their previous designs.
The company has not necessarily abandoned ARD-101.
Instead, Aardvark said it is evaluating whether and how to pursue further clinical development of the drug in patients with Prader-Willi syndrome, potentially through a redesigned clinical trial.
Aardvark also said its ability to move the program forward depends on several factors, including removal of the FDA clinical hold, reaching agreement with regulators on the design of a new trial, further analysis of HERO and other program data, and obtaining sufficient capital to fund continued development.
In its Aug. 11 second-quarter business update, Aardvark said it remained in active discussions with the FDA to resolve the ARD-101 clinical hold and was assessing unblinded HERO and open-label extension data during the third quarter of 2026.
That distinction is important for investors: the original HERO and OLE trials were terminated, but Aardvark continues to evaluate a possible future development path for ARD-101.
Financial position following clinical setback
Aardvark reported $73.9 million in cash, cash equivalents, and short-term investments as of June 30, 2026, which the company said should support operations through late 2027 under its current operating plan.
The company’s SEC filing also highlights the financial risks of being a clinical-stage biotechnology company without an approved commercial product.
As of June 30, Aardvark reported an accumulated deficit of approximately $151.9 million and said it expects to continue incurring operating losses for the foreseeable future.
Aardvark acknowledged that successful development, regulatory approval, and commercialization of its lead product candidate are important to the business’s future success.
Multiple law firms alert AARD shareholders
The lawsuit has attracted attention from several securities litigation firms.
Hagens Berman Sobol Shapiro LLP is encouraging investors who suffered substantial losses to evaluate their legal rights. The firm says it is investigating the allegations in the pending lawsuit, including claims about statements regarding ARD-101’s development, safety, and efficacy.
Pomerantz LLP has also issued notices concerning the filed class action and identifies the Southern District of California case as 26-cv-04643.
Levi & Korsinsky LLP was continuing to notify Aardvark investors about the pending securities lawsuit as recently as Sept. 10. Its notice identifies the same Feb. 13, 2025, through May 14, 2026 class period and repeats the allegations concerning ARD-101’s safety and development prospects.
Investors should understand that law-firm notices concerning securities litigation are generally attorney advertising and are intended, in part, to identify potential clients or class representatives.
The involvement of multiple firms also does not mean multiple independent class actions will necessarily proceed to trial. Securities cases involving substantially similar allegations can ultimately be consolidated, and courts determine matters such as lead-plaintiff and lead-counsel appointments.
October 13 lead plaintiff deadline
Investors covered by the proposed class have until Oct. 13, 2026, to ask the court to appoint them as lead plaintiff.
The lead plaintiff generally acts on behalf of the proposed class in directing the litigation with court-approved counsel.
The deadline should not be confused with a deadline by which every potentially affected investor must file an individual lawsuit or submit a claim for compensation. No recovery has been established, and the litigation remains pending.
Investors considering action should review the actual court filings and consult qualified legal counsel regarding their individual circumstances rather than relying solely on law-firm advertisements or news reports.
What AARD investors should watch
The securities litigation will now proceed separately from the scientific and regulatory questions surrounding ARD-101.
For shareholders, both tracks could be significant.
In court, attention will focus on whether the plaintiffs can substantiate their allegations concerning Aardvark’s statements about ARD-101 and whether the defendants ultimately succeed in challenging those claims.
From a business standpoint, investors will be watching Aardvark’s continuing discussions with the FDA, analysis of the HERO and OLE data, the status of the clinical hold, and whether the company can establish a viable path for additional ARD-101 clinical development.
Aardvark’s own disclosures make clear that significant uncertainty remains.
The company has said that further advancement of ARD-101 depends on factors including FDA action, additional data analysis, an acceptable clinical development strategy and adequate financing.
For investors who purchased AARD shares in connection with the February 2025 IPO or during the alleged class period ending May 14, 2026, the immediate legal date to watch is Oct. 13, 2026.
Legal disclaimer: This article reports on allegations contained in a pending securities class action and related public disclosures. Allegations in a complaint are not findings of fact. The defendants are entitled to contest the claims, and the sources reviewed for this report did not identify any court ruling establishing liability or wrongdoing. This article is for informational purposes only and does not constitute legal or investment advice.
