Key Takeaways:
- Aardvark Therapeutics shares fell 32% after the FDA placed a clinical hold on ARD-101
- The hold follows a voluntary trial pause in March tied to cardiac safety observations
- The stock has lost 63% of its value since late February 2026
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Aardvark Therapeutics drops 32% as FDA halts lead drug trial
Aardvark Therapeutics shares fell 32% on May 15 after the FDA placed a clinical hold on its lead drug candidate for Prader-Willi Syndrome.
"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," Reed Kathrein, partner at Hagens Berman, said.
The clinical hold follows Aardvark's voluntary pause of the Phase 3 HERO trial on March 2, 2026, which sent shares down 56% in a single session. The company said the pause was based on "reversible cardiac observations" — a serious safety signal. The FDA's hold applies to all ongoing studies under the investigational new drug application, including the HERO trial and the open-label extension trial.
The two setbacks erased $7.92, or 63%, from Aardvark's share price since Feb. 27, 2026. The clinical hold threatens the company's entire pipeline, as ARD-101 was its lead asset targeting hyperphagia in patients with PWS, a genetic disorder characterized by insatiable hunger. Aardvark had previously emphasized that ARD-101 represented a "first-in-class" drug and that, "through alignment with the FDA," it started dosing patients 13 years and older, moved to patients 10 years and older, and intended to dose patients as young as 4 years old. The company had also assured investors that ARD-101 has "a very tolerable safety profile."
The decline puts Aardvark's stock at its lowest since the initial selloff in March, testing investor confidence in the company's ability to resolve the FDA's concerns. The next catalyst will be any update from Aardvark on its response to the clinical hold and the timeline for a potential resolution.
This article is for informational purposes only and does not constitute investment advice.
