原始来源记录
决策级完整回复函 (CRL)
Aardvark：FDA对ARD-101 IND实施全面临床暂停
FDA将公司自愿暂停转为对ARD-101 IND的全面临床暂停，停止Phase 3 HERO试验和OLE试验。公司将揭盲已积累的HERO和OLE数据，以评估疗效和安全性，并指导与监管机构的下一步行动。
关键事实
来源摘录
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