Aardvark Therapeutics reports Q3 EPS (75c), consensus (80c)

In October 2025, Aardvark reached alignment with the FDA on a protocol amendment to change the minimum age of eligibility to participate in the Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with PWS trial from 13 to 10 years of age. This change broadens the eligible population for the trial and expands the potential target market within the PWS market. In addition, during the third quarter of 2025, Aardvark commenced enrollment for the HERO Open Label Extension trial and initiated its first clinical trial sites in Australia with a minimum age of eligibility to participate at 10 years of age. The OLE trial is available to patients completing the HERO clinical trial. At ObesityWeek 2025, Aardvark presented preclinical data on ARD-201 and clinical data on ARD-101 supporting the continued development of ARD-201 to attenuate weight gain, promote weight loss, and help maintain weight after the discontinuation of glucagon-like peptide-1 receptor agonist therapies. In addition, ARD-201 improved glucose tolerance and lean body mass composition. Preliminary or interim data from the Phase 2 POWER trial is anticipated to be available in 2H 2026.