Clinical TrialAug 11, 2026, 04:55 PM
Aardvark: ARD-101 Clinical Hold; Cash $73.9M into late 2027
AI Summary
Aardvark Therapeutics reported its second quarter 2026 financial results and provided pipeline updates. The company is assessing unblinded data from its Phase 3 HERO and OLE trials for ARD-101 in Prader-Willi Syndrome, which were terminated in June 2026. The ARD-101 program remains under a full clinical hold by the FDA, with active discussions ongoing to resolve the issue. As of June 30, 2026, Aardvark had $73.9 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into late 2027. The company reported a net loss of $14.4 million for the second quarter of 2026.
Key Highlights
- FDA placed a full clinical hold on ARD-101 IND program in May 2026.
- Terminated Phase 3 HERO and OLE trials for ARD-101 in June 2026.
- Assessing unblinded HERO and OLE data in Q3 2026 for next steps.
- Cash, cash equivalents, and short-term investments totaled $73.9 million as of June 30, 2026.
- Existing cash is projected to fund operations into late 2027.
- Q2 2026 R&D expenses decreased to $10.5 million from $13.1 million in Q2 2025.
- Q2 2026 G&A expenses increased to $4.6 million from $2.7 million in Q2 2025.
- Net loss for Q2 2026 was $14.4 million, consistent with Q2 2025.
Price Impact
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