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결정급보완요구서한 (CRL)
Aardvark: FDA, ARD-101 IND에 대해 전체 임상 보류 조치
FDA는 자발적 중단을 전체 임상 보류로 전환하여 ARD-101 IND에 대한 Phase 3 HERO 시험과 OLE 시험을 모두 중단했습니다. 회사는 축적된 HERO 및 OLE 데이터를 비맹검하여 효능과 안전성을 평가하고 FDA와의 다음 단계를 안내할 예정입니다.
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EX-99.1 2 ck0001774857-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Aardvark Therapeutics Plans to Unblind HERO and OLE Data to Inform Path Forward Following FDA Clinical Hold SAN DIEGO, May 14, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark or the Company) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today 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 related to the Company’s previously announced voluntary pause. The clinical hold applies to all ongoing clinical studies under the IND, including the Phase 3 HERO trial (AV