Aardvark regains FDA go-ahead for ARD-101 in Prader-Willi, with $60.3m in cash

Aardvark Therapeutics can test ARD-101 in patients again, but it does so with $60.3m in cash and exploratory efficacy data that it describes as inconclusive. The company disclosed the regulatory reversal in its third-quarter 2026 results, published on 13 November.

According to Aardvark, the US Food and Drug Administration released the programme from its restriction in October 2026. ARD-101 is being developed for hyperphagia, the excessive hunger associated with Prader-Willi syndrome. The agency had asked for an ECG study and an in vitro study of the cardiac sodium channel. The company says neither found QRS or QT prolongation at 200 mg or 400 mg taken twice daily.

The regulator has agreed to an open-label study at 200 mg twice daily, the lower of the two doses assessed in the cardiac work. Aardvark has a meeting with the agency on its wider development plan in the first quarter of 2027. That session is the first chance to see what the FDA expects beyond the open-label study. The company has not given details of trial design, enrolment or timelines in the material available.

The update also recorded setbacks. Aardvark described exploratory data from its terminated HERO and OLE trials as inconclusive. It also noted a serious cardiac event that the FDA attributed to a CYP2D6 interaction with pitolisant. No revenue, financing or partnering information accompanied the news.