(RTTNews) - On Thursday, Aardvark Therapeutics, Inc. (AARD), a clinical-stage biopharmaceutical company, said that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on ARD-101 for hyperphagia in Prader-Willi syndrome.

Prader-Willi syndrome is a rare genetic disorder characterized by insatiable hunger. ARD-101 is an investigational oral small molecule designed to activate bitter taste receptors and stimulate the release of gut-peptide hormones.

Aardvark voluntarily paused dosing in its Phase 3 HERO trial and open-label extension (OLE) study on February 27 subsequent to reversible electrocardiogram (ECG) changes in a separate healthy-volunteer study.

The FDA subsequently imposed a clinical hold on both studies in May 2026.

After consulting with the FDA, Aardvark conducted an additional ECG study in healthy volunteers and a laboratory cardiac sodium-channel study. No cardiac events were observed in the ECG study at doses of 200 mg and 400 mg twice daily.

As previously announced, Aardvark unblinded the accumulated HERO and OLE trial data to assess the available efficacy and safety findings.

The company plans to resume clinical development after further talks and alignment with the FDA on the Phase 3 trial design.

Aardvark will review available exploratory data from the terminated HERO and extension trials during a webcast on October 23 at 8 a.m. ET.

AARD closed at $3.95, down 10.43%.

In overnight trading, shares are up 16.96% at $4.62.

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