Aardvark Therapeutics Reports Exploratory Phase 3 HERO And OLE Data Showing Rapid Hunger Score Reductions With ARD-101 In PWS, FDA Lifts Clinical Hold And Company Targets New Phase 3 Trial

• HERO trial terminated early (67 of 90 planned participants randomized); all efficacy data are considered exploratory
• HQ-CT scores fell by Week 2 of dose escalation on ARD-101 and returned to near baseline within two weeks of stopping treatment, with less rebound on placebo
• OLE participants switching from placebo to ARD-101 saw a further reduction in HQ-CT scores by Day 28
• ARD-101 was well tolerated; most adverse events mild to moderate
• FDA lifted full clinical hold on ARD-101; Company plans to request FDA meeting to align on new Phase 3 trial design and expects to resume PWS clinical activities in 2027
• Conference call and webcast today at 8:00 a.m. ET

SAN DIEGO, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark or the Company) (NASDAQ:AARD), a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi syndrome (PWS) and metabolic diseases, today reported exploratory efficacy data from its previously terminated Phase 3 Hunger Elimination or Reduction Objective (HERO) trial and open-label extension (OLE) trial. As previously announced, Aardvark unblinded the data accumulated across both the HERO trial and OLE trial to assess the totality of available efficacy and safety data to inform the path forward for ARD-101.