Aardvark Therapeutics, Inc. develops clinical-stage small-molecule therapeutics for metabolic diseases by targeting innate homeostatic pathways, including compounds directed at Bitter Taste Receptors. News about AARD centers on ARD-101 for hyperphagia associated with Prader-Willi Syndrome, the HERO clinical program, ARD-201 obesity studies, and interactions with regulators and review boards around trial protocols and safety monitoring.
Company updates also cover quarterly financial results, equity incentive grants, leadership appointments, and the establishment of Ardia Therapeutics, a wholly owned U.S. subsidiary supporting a dermatology pipeline led by DIA-615 for inflammatory skin diseases.
Aardvark Therapeutics (Nasdaq: AARD) announced U.S. IRB approval and an FDA submission of an amended Phase 3 HERO trial protocol for lead candidate ARD-101, lowering minimum participant age from 10 to 7 years.
The amendment expands U.S. enrollment to younger children with Prader-Willi syndrome and the company says enrollment remains on track to report topline data in Q3 2026.
Aardvark Therapeutics (Nasdaq: AARD) announced dosing of the first patient in Australia in its Phase 3 HERO trial of ARD-101 for hyperphagia in Prader-Willi syndrome on Dec 10, 2025.
Regulatory clearance to enroll has been received for sites in Canada and the United Kingdom. US sites report strong enrollment and Australia sites began enrolling in November. All patients who completed the 12-week trial to date have entered the Open Label Extension. The company says the study is tracking toward a topline data readout in Q3 2026 and expects not to need previously planned EU sites to meet that timeline.
Aardvark Therapeutics (Nasdaq: AARD) will present at two investor conferences in December: Piper Sandler 37th Annual Healthcare Conference in New York on Wednesday, December 3, 2025 at 8:00 a.m. ET and Evercore ISI 8th Annual Healthcare Conference in Miami on Thursday, December 4, 2025 at 11:15 a.m. ET.
Live webcasts of each presentation will be accessible on the company investor website and an archived recording will be available there for approximately one month after each presentation.
Aardvark Therapeutics (Nasdaq: AARD) reported Q3 2025 results and pipeline updates on Nov 13, 2025. The company disclosed $126.4 million in cash, cash equivalents, and short-term investments as of Sept 30, 2025, which it expects will fund operations into 2027. Aardvark aligned with the FDA to lower the HERO Phase 3 ARD-101 trial minimum age from 13 to 10 years and started the HERO Open Label Extension with sites in Australia. Preclinical data for oral ARD-201 showed glucose control, lean mass preservation, ~19% weight reduction in mice, and ~30% weight loss when combined with low-dose tirzepatide. Topline HERO data expected Q3 2026; POWER interim data expected 2H 2026.
Aardvark Therapeutics (Nasdaq: AARD) announced an inducement equity award granted on November 10, 2025 to one new employee under its 2025 Inducement Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4). The award is a stock option to purchase 4,881 shares of common stock with an exercise price equal to the closing price on the grant date, $10.44. The option vests over four years: 25% vest on the one-year anniversary of employment commencement and the remainder vests monthly at 1/48th thereafter, subject to continued employment.
Aardvark Therapeutics (Nasdaq: AARD) presented preclinical and clinical data at ObesityWeek 2025 supporting its metabolic obesity programs ARD-201, ARD-101 and WE-868.
Key highlights: ARD-201 (fixed-dose ARD-101 + sitagliptin) reduced fat mass comparable to high-dose tirzepatide while preserving lean mass, delivered glucose control comparable to high-dose tirzepatide, and previously showed ~19% weight reduction after 30 days and ~30% weight loss when combined with low-dose tirzepatide. ARD-101 showed signals of weight control, reduced hunger, and favorable tolerability in a Phase 2a study. WE-868 showed dose-dependent prevention of diet-induced weight gain in preclinical models.
Aardvark Therapeutics (Nasdaq: AARD) announced inducement equity option grants for new hires under Nasdaq Listing Rule 5635(c)(4).
The company granted options on three dates: Oct 20, 2025 (23,602 shares at $12.28), Oct 28, 2025 (aggregate 49,849 shares at $12.00), and Nov 3, 2025 (14,766 shares at $10.39), totaling 88,217 option shares. Each option’s exercise price equals the closing stock price on the grant date. Options vest over four years with 25% at the one-year anniversary and monthly vesting thereafter, subject to continued employment.
Aardvark Therapeutics (Nasdaq: AARD) will present at two investor conferences in November 2025: the Stifel 2025 Healthcare Conference in New York on Tuesday, November 11 at 4:40 p.m. ET, and the TD Cowen Treatment Advancements in Obesity & Related Disorders Summit (virtual) on Monday, November 24 at 3:00 p.m. ET. Live webcasts of both presentations will be available via the company investor website and archived for approximately one month after each presentation.
Aardvark Therapeutics (Nasdaq: AARD) will present clinical and preclinical data at ObesityWeek 2025 in Atlanta on November 4-7, 2025. Two poster presentations on Tuesday, November 4, 2025 at 7:30 p.m. ET include:
- ARD-101 (TAS2R pan-agonist) — data showing attenuation of weight gain in mice and reduced hunger in adults with obesity; presenter: Timothy Kieffer, Ph.D., CSO.
- WE-868 (isoflavonoid modulator of oxidative metabolism) — therapeutic potential in obesity and diabetes; presenter: Tien Lee, M.D., CEO.
Aardvark will host an investor webinar on Wednesday, November 5, 2025 from 5:00–7:00 p.m. ET to review ARD-101, ARD-201 and WE-868 data, include key opinion leaders, and discuss ARD-101 in Prader-Willi Syndrome with PWS Association USA. The live webcast and an archived recording (available for ~one month) will be on the company website under the Investors tab.
Aardvark Therapeutics (Nasdaq: AARD) announced FDA alignment on a protocol amendment to its Phase 3 HERO trial of ARD-101 for hyperphagia in Prader-Willi syndrome (PWS).
The amendment lowers minimum enrollment age from 13 to 10 years, broadening the eligible patient population. Management cited community support and historical data suggesting younger patients may benefit more from early intervention. The company reaffirmed a planned topline data readout in Q3 2026.