FDA Lifts Clinical Hold on ARD-101, Reviving PWS Program
AARD sits 18% above its 52-week low of $3.35.
Summary
The FDA lifted the clinical hold on Aardvark's ARD-101 IND for hyperphagia in Prader-Willi syndrome, clearing the path to resume clinical development. The hold followed the company's February 27, 2026 voluntary dosing pause after reversible ECG changes in a healthy-volunteer study, and the FDA's May 2026 hold on the Phase 3 HERO and OLE trials. Aardvark says a follow-up ECG study at 200 mg and 400 mg twice daily produced no cardiac events, and an in vitro NaV1.5 study was completed. This is the first real unlock for a program that was effectively shelved in August, when the company terminated both Phase 3 trials and reported a $14.4M Q2 net loss with $73.9M in cash. Restart still depends on further FDA alignment on Phase 3 design, and the HERO and OLE data were unblinded from terminated trials not powered for efficacy. Management reviews that dataset on the October 23, 2026 webcast at 8:00 a.m. ET — that call is where the efficacy readout either supports a new Phase 3 or kills the thesis.
At the time of this announcement, AARD was trading at $3.95 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $86.4M. The 52-week trading range was $3.35 to $16.60. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.