8/102 sources · 2 publishersUpdated Oct 22, 21:42 UTC
FDA lifts clinical hold on Aardvark Therapeutics' ARD-101
The U.S. Food and Drug Administration removed the clinical hold on ARD-101, Aardvark Therapeutics' oral drug for hyperphagia in Prader‑Willi Syndrome. The company will restart development after further discussions with the agency and will present the trial data in an online session on October 23, 2026. Earlier studies showed no cardiac events at the tested doses.
Why it matters
Aardvark's shares rose 21% in after‑hours trading following the announcement, reflecting investor optimism about the resumed program. The removal of the hold clears a regulatory obstacle, allowing the Phase 3 trial to move forward.
Key facts
- 1The FDA lifted the clinical hold on ARD-101 on October 22, 2026. tradingview.com
- 2ARD-101 is being developed to treat hyperphagia in patients with Prader‑Willi Syndrome. tradingview.com
- 3Aardvark conducted an additional ECG study in healthy volunteers at doses of 200 mg and 400 mg twice daily with no cardiac events observed. investing.com
- 4The company plans to resume clinical development of ARD-101 after further engagement with the FDA on Phase 3 trial design. investing.com
- 5Aardvark will hold an online presentation on October 23, 2026, at 8:00 a.m. Eastern Time to discuss the dataset from the terminated trials. investing.com
- 6Aardvark's stock jumped 21% in after‑hours trading after the hold was lifted. investing.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.