Aardvark to review unblinded ARD-101 data in Q3 2026 amid FDA clinical hold
The company ended its HERO and OLE trials in June 2026 and is reviewing unblinded data while working with the FDA to resolve a hold on ARD-101's IND.
Aardvark Therapeutics reported second quarter 2026 results on August 11, 2026, alongside updates on its ARD-101 program for Prader-Willi Syndrome hyperphagia. The company is reviewing unblinded clinical data gathered so far from both the HERO trial and the OLE trial in order to weigh overall efficacy and safety findings and decide on next steps for ARD-101.1 In June 2026, Aardvark ended the HERO and OLE trials and said it does not currently plan to restart them in their original form.1
In May 2026, the FDA placed a full clinical hold on Aardvark's investigational new drug application for ARD-101, following a voluntary pause the company had previously disclosed.1 That hold covers every clinical study that had been running under the IND, including the Phase 3 "HERO" trial for hyperphagia in Prader-Willi Syndrome and the Phase 3 OLE trial.1 CEO Tien Lee said the company has continued to work with the FDA over recent months, and that in the third quarter of 2026 it is assessing unblinded HERO and OLE data to understand the full efficacy and safety picture generated to date.1 Aardvark said it remains in active discussions with the FDA aimed at resolving the clinical hold, as stated in the release's summary bullets.
On finances, Aardvark held $73.9 million in cash, cash equivalents and short-term investments as of June 30, 2026, down from $91.2 million at March 31, 2026.1 The company said this is sufficient to fund planned operations into late 2027.1 Net loss was $14.4 million in the second quarter of 2026, essentially unchanged from the same period in 2025.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.