Aardvark Therapeutics Announces FDA Has Lifted the Clinical Hold on ARD-101 for the Treatment of Prader-Willi Syndrome and Will Host Webcast to Review the Available Exploratory Phase 3 HERO/OLE Data
Globe Newswire•22/10/2026•16:05 ET
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Key Highlights
- ➤FDA lifted clinical hold on ARD-101 for Prader-Willi Syndrome hyperphagia
- ➤Aardvark may resume clinical development after additional FDA alignment on Phase 3 design
- ➤No cardiac events observed at 200 mg and 400 mg twice-daily doses in ECG study
- ➤Aardvark unblinded terminated HERO and OLE trial data for efficacy and safety assessment
- ➤Webcast on October 23, 2026, will review available HERO and OLE trial data
Expert Statements
Tien Lee, Founder and Chief Executive Officer of Aardvark Therapeutics
“We are pleased that the FDA has lifted the clinical hold on ARD-101, allowing us to continue advancing our clinical development program”
Tien Lee, Founder and Chief Executive Officer of Aardvark Therapeutics
“With strong alignment and collaboration with the FDA, we completed the work necessary to allow for the resumption of clinical studies.”
Tien Lee, Founder and Chief Executive Officer of Aardvark Therapeutics
“People living with PWS and their families continue to face profound unmet need, and we look forward to working with the FDA as we advance ARD-101.”
Clinical development of ARD-101 for hyperphagia in Prader-Willi Syndrome (PWS) may resume
Aardvark will host a webcast to review available dataset from the terminated Phase 3 HERO trial and OLE trial on Friday, October 23, 2026, at 8:00 a.m. EST
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