Aardvark Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Updates
Globe Newswire•13/11/2026•08:00 ET
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Key Highlights
- ➤FDA lifted ARD-101’s clinical hold for Prader-Willi Syndrome hyperphagia
- ➤FDA agreed to an open-label ARD-101 trial at 200 mg twice daily
- ➤Aardvark expects to resume PWS clinical activities in 2027, subject to FDA alignment
- ➤Cash, equivalents and short-term investments totaled $60.3 million, funding operations through 2027
- ➤Third-quarter net loss widened to $19.2 million from $16.3 million year over year
Expert Statements
Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark Therapeutics
“The lifting of the clinical hold and the FDA’s agreement that we may conduct an open-label trial at 200 mg twice daily are important steps toward resuming clinical development of ARD-101 in PWS”
Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark Therapeutics
“We have developed a proposed clinical development plan and look forward to discussing it with the FDA. We remain committed to advancing ARD-101 for patients and families affected by PWS.”
FDA lifted clinical hold on ARD-101 for the treatment of hyperphagia in Prader-Willi Syndrome (PWS)
Meeting with the FDA scheduled for the first quarter of 2027 to discuss the Company’s proposed clinical development plan for ARD-101; Company expects to resume PWS clinical activities in 2027
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