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Aardvark Therapeutics, Inc.Bullish
AI summary pendingAardvark Therapeutics reported exploratory efficacy data from its previously terminated Phase 3 HERO and open-label extension (OLE) trials. Following the FDA's decision to lift the clinical hold on ARD-101, the company plans to align with the FDA on a new Phase 3 trial design and expects to resume clinical activities in 2027.…more
Aardvark Therapeutics, Inc.
The U.S. FDA has lifted the clinical hold on the Investigational New Drug application for ARD-101, intended for the treatment of hyperphagia in Prader-Willi Syndrome. Aardvark Therapeutics will resume clinical development and host an investor conference call on October 23, 2026, at 8:00 a.m. ET to review data from the terminated HERO and OLE trials.…more
Aardvark Therapeutics, Inc.
Insider Zhang Zhongwei of Aardvark Therapeutics, Inc. filed a Form 4 report regarding changes in beneficial ownership of securities, effective October 7, 2026.…more
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Aardvark Therapeutics Shares Plunge on Insufficient Clinical Data
Aardvark Therapeutics shares fell over 56% after the company released exploratory data from its terminated Phase 3 trial, which was deemed insufficient for definitive conclusions. Despite the FDA lifting a clinical hold on the drug, the company must now adjust dosing protocols to continue development.…more
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Aardvark Therapeutics released exploratory data from its prematurely terminated Phase 3 trial and plans to consult with the FDA to resume clinical activities. Due to the early termination, the data is not definitive, and the company's path forward depends on aligning with the FDA on a new trial design.…more
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Aardvark Therapeutics announced that the FDA has lifted the clinical hold on its Prader-Willi syndrome drug candidate, ARD-101, following the resolution of cardiac safety concerns. This regulatory clearance restores the company's path to resume clinical development for the rare genetic disorder.…more
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