Robbins LLP is Investigating Allegations that Aardvark Therapeutics, Inc. Misled Investors Regarding the Viability and Efficacy of its Lead Drug Candidate ARD-101

 Robbins LLP informs investors that a class action was filed on behalf of all persons and entities who purchased or otherwise acquired Aardvark Therapeutics, Inc. (NASDAQ: AARD) (a) common stock pursuant to the Company's February 13, 2025 initial public offering ("IPO") and/or (b) securities between February 13, 2025 and May 14, 2026 (the "Class Period"). Aardvark is a clinical-stage biopharmaceutical company that focuses on developing small-molecule therapies designed to inhibit hunger and treat metabolic diseases such as Prader-Willi Syndrome (“PWS”), a neurodevelopmental disorder condition that presents hyperphagia, or a feeling of extreme, insatiable hunger.

The complaint alleges that Aardvark misled investors regarding the viability and efficacy of its lead drug candidate ARD-101.  

Investors who suffered significant losses during the Class Period may be eligible to participate in the lawsuit and should contact Robbins LLP for information about becoming lead plaintiff.

Why Was Aardvark Therapeutics Sued?

The complaint alleges that the Company’s lead product candidate is ARD-101, which defendants have repeatedly described as a “gut-restricted” small-molecule agonist of certain TAS2Rs expressed in the gut lumen. To evaluate the effect of ARD-101on hyperphagia-related behavior in patients with Praqder-Willi Syndrome, defendants commenced both a Phase 3 clinical trial, referred to as the HERO trial, and an open-label extension.

The Offering Documents in support of the IPO informed investors that the preclinical data concerning ARD-101 "suggest that ARD-101 shows potential to be a well-tolerated, satiety-inducing drug."

Notwithstanding, the complaint alleges that defendants failed to disclose that:

• ARD-101 was less safe than defendants had led investors to believe;
• accordingly, ARD-101’s clinical, regulatory, and commercial prospects were overstated; and
• as a result, defendants’ public statements were materially false and misleading at all relevant times.

Why Did AARD Stock Drop?

The complaint alleges that on February 27, 2026, Aardvark issued a press release “announc[ing] it is voluntarily pausing the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial.” Aardvark attributed the decision to “reversible cardiac observations at above target therapeutic doses found during routine safety monitoring in a healthy volunteer study” and said that it “has voluntarily paused ongoing enrollment and dosing in the HERO trial” while “conducting a comprehensive review of the data to inform next steps.” On this news, Aardvark’s stock price fell $7.02 per share, or 56.2%, to close at $5.47 per share on March 2, 2026.

Then, on May 14, 2026, Aardvark issued a press release “announc[ing] that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101 related to the Company’s previously announced voluntary pause.” The press release specified that “[t]he clinical hold applies to all ongoing clinical studies under the IND, including the Phase 3 HERO trial (AVK-101-301) evaluating ARD-101 for the treatment of hyperphagia in patients with Prader-Willi Syndrome (PWS) and the Phase 3 open-label extension (OLE) trial (AVK-101-302).” On this news, Aardvark’s stock price fell $2.16 per share, or 32.1%, to close at $4.57 per share on May 15, 2026.

Who May Be Eligible to Participate in the AARD Class Action?

The lawsuit seeks to represent investors who purchased or otherwise acquired

• AARD common stock pursuant to the Company's February 13, 2025 IPO; and/or
• AARD securities between February 13, 2025 and May 14, 2026

Investors who suffered losses during that period may have legal rights under the federal securities laws.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.