USFDAMay 14, 2026, 04:02 PM
Aardvark Therapeutics' ARD-101 Program Placed on Full FDA Clinical Hold
AI Summary
Aardvark Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101. This hold affects all ongoing clinical studies, including the Phase 3 HERO trial for Prader-Willi Syndrome and the open-label extension trial. The company is actively engaging with the FDA to resolve the hold and plans to unblind accumulated clinical data to determine the program's future. As of March 31, 2026, Aardvark reported $91.2 million in cash, cash equivalents, and short-term investments, expected to fund operations into mid-2027.
Key Highlights
- FDA placed a full clinical hold on Aardvark Therapeutics' ARD-101 investigational new drug application (IND).
- The clinical hold impacts all ongoing studies, including the Phase 3 HERO trial and the OLE trial.
- Aardvark Therapeutics is actively discussing with the FDA to resolve the clinical hold.
- The company intends to unblind clinical data from both HERO and OLE trials for assessment.
- 68 patients were dosed in the HERO trial and 19 in the OLE trial as of February 27, 2026.
- Aardvark held $91.2 million in cash, cash equivalents, and short-term investments as of March 31, 2026.
- The company projects its current funds are sufficient to support operations into mid-2027.