Aardvark Therapeutics (AARD) Scrutinized Again After FDA Hold on Lead Drug Candidate, May Announcement Drives Stock 32% Lower - Hagens Berman

SAN FRANCISCO, July 22, 2026 /PRNewswire/ -- On May 15, 2026, investors in Aardvark Therapeutics (NASDAQ: AARD) saw the price of their shares significantly decline again – this time, the shares fell $2.16 (-32%). The decline was driven by news that the FDA placed a clinical hold on the company's Prader-Willi Syndrome ("PWS") asset.

Previously, on March 2, 2026, the price of their shares cratered $7.02 (-56%) after the company announced that it stopped its Phase 3 Hunger Elimination of Reduction Objective ("HERO") trial evaluating the efficacy and safety of ARD-101 as a treatment for hyperphagia (insatiable hunger) in patients with PWS.

The developments and severe market reactions support national shareholder rights firm Hagens Berman's continuing investigation into whether Aardvark may have misled investors in violation of federal securities laws.  The firm encourages Aardvark investors who suffered substantial losses to submit your losses now and invites persons with knowledge who may be able to assist the investigation to contact its attorneys.

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Aardvark Therapeutics (AARD) Investigation:

The investigation continues to focus on the propriety of Aardvark's disclosures about ARD-101 safety and efficacy data, along with disclosures regarding communications with the FDA.

Aardvark had emphasized that ARD-101 represented a "first-in-class" drug and that, "through alignment with the FDA," it started HERO patients 13 years and older, moved to dosing patients 10 years and older, and intended to dose patients as young as 4 years old. The company has also assured investors that ARD-101 has "a very tolerable safety profile."

But Aardvark's May 14, 2026 announcement appears to bring into question these representations. The company said the FDA placed a full clinical hold on its investigational new drug ("IND") application for ARD-101 related to its voluntary pause of the HERO trial announced on March 2, 2026. "The clinical hold applies to all ongoing clinical studies under the IND, including the Phase 3 HERO trial […] and the Phase 3 open label extension (OLE) trial[,]" the company explained.

Previously, Aardvark said its decision to pause the HERO trial was based on a serious safety risk – namely, "reversible cardiac observations[.]"

The market swiftly reacted to each of these events. By May 15, 2026, the selloff erased $7.92 (63%) from the stock's February 27, 2026 closing price and it hasn't come close to recovering.

"We're focused on whether Aardvark may have misled investors about ARD-101's development, its safety and/or efficacy, and the company's communications with the FDA," said Reed Kathrein, the Hagens Berman partner leading the firm's investigation.

If you invested in Aardvark Therapeutics and have substantial losses, or have knowledge that will assist the firm's investigation, submit your losses now »

If you'd like more information and answers to frequently asked questions about the firm's Aardvark investigation, read more »

Whistleblowers: Persons with non-public information regarding Aardvark Therapeutics should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected].

About Hagens Berman
Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw. 

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SOURCE Hagens Berman Sobol Shapiro LLP