Rosen Law Firm Announces Class Action Lawsuit Against Aardvark Therapeutics Over Drug Safety Disclosures
Rosen Law Firm has announced a securities class action lawsuit against Aardvark Therapeutics, Inc. (NASDAQ: AARD), alleging the San Diego-based biotech company made materially false statements about the safety of its lead drug candidate. Investors who purchased Aardvark securities between February 13, 2025 and May 14, 2026 may be entitled to compensation.
The lawsuit centers on ARD-101, an oral drug being developed to treat excessive hunger associated with Prader-Willi Syndrome. ARD-101 works as a gut-restricted agonist of bitter taste receptors and was the company's primary development program.
IPO and Clinical Development
Aardvark completed its initial public offering on February 13, 2025, selling 6,120,661 shares at $16.00 per share and raising approximately $87.5 million in net proceeds after underwriting costs. The company, founded in 2017, is led by CEO Dr. Tien-Li Lee, who holds approximately 19% of the company.
At the time of the IPO, Aardvark was conducting the Phase 3 HERO trial, testing ARD-101 against placebo in Prader-Willi Syndrome patients ages 7 and older over a three-month period. Early Phase 1 trials in healthy volunteers had shown ARD-101 was generally safe and well-tolerated, with more than 99% of the medication remaining in the digestive tract rather than being absorbed into the bloodstream.
FDA Clinical Hold
On May 14, 2026, the FDA placed a full clinical hold on Aardvark's investigational new drug application for ARD-101, following the company's voluntary pause of enrollment and dosing in the HERO trial. The hold was triggered by temporary changes in heart electrical activity observed in healthy volunteers given ARD-101 at high doses of 1,600 mg twice daily and 800 mg twice daily. These cardiac effects resolved after stopping therapy.
The stock price fell $2.16, or 32%, on May 15, 2026, the day following the FDA announcement. By that date, the selloff had erased $7.92, representing a 63% decline from the stock's February 27, 2026 closing price. In June 2026, Aardvark terminated the HERO trial and announced it does not currently intend to resume it.
Lawsuit Allegations
According to the complaint, defendants failed to disclose that ARD-101 was less safe than represented to investors, and consequently overstated the drug's clinical, regulatory, and commercial prospects. The lawsuit alleges these omissions rendered defendants' public statements materially false and misleading throughout the class period.
The class action covers two groups of investors: those who purchased common stock pursuant to the company's February 2025 IPO registration statement, and those who bought securities during the broader class period from February 13, 2025 through May 14, 2026.
Legal Deadlines and Next Steps
Under the Private Securities Litigation Reform Act, investors have 60 days from the first filing of a class action complaint to petition the court to serve as lead plaintiff. In this case, the deadline is October 13, 2026. A lead plaintiff serves as a representative party directing the litigation on behalf of other class members.
Rosen Law Firm is representing investors through a contingency fee arrangement, meaning investors can participate without paying out-of-pocket fees. The firm has stated that investors may select counsel of their choice or remain absent class members. As of March 31, 2026, Aardvark reported $91.2 million in cash, cash equivalents, and short-term investments, which the company stated would support operations into mid-2027.
No class has yet been certified in the litigation. Interested investors can obtain more information by contacting Phillip Kim at Rosen Law Firm toll-free at 866-767-3653 or via email at [email protected].
