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FDA lifts clinical hold on Aardvark's ARD-101 for Prader-Willi Syndrome treatment, resuming trials.

Market News
22 Oct 2026
GlobeNewsWire
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Bullish
FDA lifts clinical hold on Aardvark's ARD-101 for Prader-Willi Syndrome treatment, resuming trials.

The FDA has lifted the clinical hold on Aardvark Therapeutics' investigational drug ARD-101, designed to treat hyperphagia in Prader-Willi Syndrome (PWS), allowing clinical trials to resume. The hold was placed after ECG changes were observed in a separate study, but further testing showed no cardiac events at therapeutic doses. Aardvark plans to continue development following further FDA discussions and will host a webcast to discuss data from the terminated Phase 3 HERO and OLE trials. This development is significant as ARD-101 targets a critical unmet need in PWS, a rare genetic disorder causing insatiable hunger.

The news about Aardvark Therapeutics and its ARD-101 drug for Prader-Willi Syndrome is provided here with a snapshot of the Health sector on Pluang. For readers following Health stocks, as of Oct 23, 2026 02:41 WIB, out of 150 priced US Health-sector stocks, 77 rose and 71 fell. Notable movers include SLS at USD 11.21 with a 1-day change of -7.66% and a typical hold time of 4 days, ABCL at USD 11.34 down 7.35% but with Pluang order activity showing 0% Sell and 100% Buy and a typical hold time of 41 days, and MRVI at USD 7.08 down 6.47% with 0% Sell and 100% Buy order activity and a typical hold time of 4 days.

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