Aardvark Therapeutics, Inc. AARD
Aardvark Therapeutics, Inc. (Nasdaq: AARD) is a rare genetic drug developer. Its lead program, ARD-101, is in Phase 3 for Hyperphagia associated with Prader-Willi Syndrome.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ARD-101 | Hyperphagia associated with Prader-Willi Syndrome (Phase 3 HERO, terminated June 2026; FDA clinical hold May 2026) | small molecule | Phase 3 |
| ARD-201 (ARD-101 + DPP-4 inhibitor) | Obesity / prevention of weight regain after GLP-1RA therapy (Phase 2 POWER initiated Dec 2025, paused Feb 2026) | small molecule | Phase 2 |
Recent results and decisions
- Oct 31, 2026hold lifted FDA lifted the clinical hold on ARD-101 in October 2026.
OCT 2026 PHASE 3 Clinical Hold Lifted FDA lifted the clinical hold
Filing - May 31, 2026clinical hold FDA placed ARD-101 on clinical hold in May 2026 following QRS findings and a serious adverse cardiac event in the HERO trial.
Trial paused February 27, 2026; all participants stopped dosing FDA Clinical hold May 2026
Filing - Mar 23, 2026negative Healthy-volunteer cardiac study: 2 of 8 dosed at 1,600 mg BID had QRS increase >25%; in 800 mg BID follow-on cohort 1 of 23 had <25% and 1 had >25% QRS increase; all reversible and non-serious.
Two of eight participants experienced increases in QRS duration greater than 25% from baseline, and one additional participant had a QRS increase of less than 25% from baseline.
Filing
7 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 rare genetic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.