Aardvark Therapeutics, Inc. reported its financial results for the third quarter ended September 30, 2026, and provided an update on its clinical development program for ARD-101, a small-molecule therapeutic for Prader-Willi Syndrome (PWS). The company announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Investigational New Drug (IND) application for ARD-101.

To satisfy FDA requirements, Aardvark conducted an electrocardiogram (ECG) study in healthy volunteers and an in vitro cardiac sodium channel study. The study found no prolongation of the QRS or QT intervals at doses of 200 mg or 400 mg twice daily. The FDA has agreed that the company may conduct an open-label trial at 200 mg twice daily in patients with PWS.

Aardvark also provided exploratory data from the terminated Phase 3 HERO trial and the open-label extension (OLE) trial. The HERO trial randomized 67 of the planned 90 participants before it was terminated early. In the trial, Hyperphagia Questionnaire for Clinical Trials (HQ-CT) scores decreased in both treatment groups, with numerically greater reductions for ARD-101 than placebo at Weeks 2, 4, and 8. In the OLE cohort, participants who switched from placebo to ARD-101 experienced an average additional reduction of 6 points in HQ-CT score after four weeks of treatment.

Regarding safety, ARD-101 was generally well tolerated. In the HERO trial, treatment-emergent adverse events were reported in 52% of ARD-101 participants and 50% of placebo participants. One serious cardiac adverse event was observed at 800 mg twice daily in a participant also taking pitolisant; the FDA concurred this event was due to a drug-drug interaction, as ARD-101 inhibits CYP2D6, the enzyme that metabolizes pitolisant.

The company has scheduled a meeting with the FDA for the first quarter of 2027 to discuss its proposed clinical development plan. Aardvark expects to resume PWS clinical activities in 2027, subject to FDA alignment. The company had $60.3 million in cash, cash equivalents, and short-term investments as of September 30, 2026, which it believes will be sufficient to fund projected operations through 2027.

On the corporate front, Aardvark appointed David Zhang, Ph.D., MBA, to its Board of Directors in October 2026. Dr. Zhang brings over 25 years of experience in clinical strategy and biostatistics, including oversight of the pivotal trial design for CAMZYOS (mavacamten).

For the third quarter of 2026, Aardvark reported research and development expenses of $15.7 million and general and administrative expenses of $4.0 million. The company reported a net loss of $19.2 million for the quarter.