原始来源记录
决策级临床试验登记变更
Aardvark 暂停 HERO/OLE 和 ARD-201 3 期试验；2026 年 Q2 提供指引
Aardvark 自愿暂停 ARD-101 用于 PWS 贪食症的 3 期 HERO 和 OLE 试验的入组与给药，并在健康志愿者心脏安全性研究中观察到可逆性 QRS 延长信号后暂停 ARD-201 肥胖项目。公司正在与 FDA 共同审阅数据，并将于 2026 年 Q2 就两个项目提供进一步指引。
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 Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates Voluntary pause of the Phase 3 HERO and OLE trials evaluating ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi Syndrome, further guidance on the program expected in Q2 2026 ARD-201 obesity program, including POWER and STRENGTH trials, on voluntary pause pending next steps with ARD-101; further guidance on the program expected in Q2 2026 Clinical and preclinical data from ARD-101 program published in Molecular Metabolism $110.0 million in cash, cash equivalents and short-term investments as of December 31, 2025, supports projected operations into the second quarter of 2027 SAN DIEGO, Ma