Aardvark Pauses ARD-101 Phase 3 HERO and ARD-201 Trials After Cardiac Findings
AARD•Aardvark Therapeutics paused enrollment and dosing in its Phase 3 HERO and OLE trials of ARD-101 and halted ARD-201 development after reversible cardiac observations in a healthy volunteer study, with further guidance expected in Q2 2026. It closed Q1 2026 with $91.2 million in cash supporting operations into mid-2027.
1. Pipeline Pause Details
In February 2026, Aardvark voluntarily paused enrollment and dosing in its Phase 3 HERO and open-label extension trials of ARD-101 for Prader-Willi Syndrome and in the ARD-201 obesity program following unexpected reversible cardiac observations in a separate healthy volunteer study. The company is conducting a comprehensive data review with the FDA and expects to provide further guidance in Q2 2026.
2. First Quarter 2026 Financial Highlights
Aardvark ended Q1 2026 with $91.2 million in cash, cash equivalents and short-term investments, down from $110.0 million at year-end 2025, providing runway into mid-2027. R&D expenses rose to $16.6 million from $7.8 million year-over-year, G&A increased to $5.9 million from $2.7 million, and net loss widened to $21.6 million from $9.3 million.
3. Outlook and Next Steps
The company is collaborating closely with the FDA to determine the path forward for ARD-101 and ARD-201, aiming to deliver detailed updates in the second quarter. Management remains focused on advancing its innate homeostatic pathway therapeutics and preserving cash resources to support ongoing development milestones.
