Welcome to our dedicated page for Aardvark Therapeutics news (Ticker: AARD), a resource for investors and traders seeking the latest updates and insights on Aardvark Therapeutics stock.
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) reported that the FDA has placed a full clinical hold on its IND for ARD-101, covering the Phase 3 HERO and OLE trials in Prader-Willi syndrome hyperphagia. Aardvark plans to unblind existing data and, with $91.2 million in cash, expects funding into mid-2027.
Aardvark Therapeutics (Nasdaq: AARD) reported Q1 2026 results and business updates on May 7, 2026. The company disclosed voluntary pauses in enrollment and dosing for ARD-101 Phase 3 HERO and OLE trials and for ARD-201, with further guidance expected in Q2 2026.
Cash, cash equivalents and short-term investments were $91.2 million as of March 31, 2026, sufficient to fund operations into mid-2027 per the company. Q1 R&D was $16.6M, G&A $5.9M, and net loss was $21.6M.
Aardvark Therapeutics (Nasdaq: AARD) announced a voluntary pause of Phase 3 HERO and OLE trials of ARD-101 after reversible QRS prolongation observations in healthy volunteers; exposure-response modeling links higher plasma levels to QRS effects. ARD-201 obesity trials are also paused pending ARD-101 review. Clinical/preclinical ARD-101 data were published in Molecular Metabolism. As of December 31, 2025, cash and equivalents were $110.0M, funding operations into Q2 2027. R&D and G&A expenses and net loss increased materially in 2025.
Aardvark Therapeutics (Nasdaq: AARD) has voluntarily paused the Phase 3 HERO trial (NCT06828861) and its open-label extension (NCT07197034) for ARD-101 in Prader-Willi syndrome due to reversible cardiac observations at above-target doses observed in a healthy volunteer study.
The company paused enrollment and dosing while conducting a comprehensive data review, will collaborate with the FDA and experts, and now expects to delay topline HERO data previously planned for Q3 2026, with further guidance expected in Q2 2026.
Aardvark Therapeutics (Nasdaq: AARD) announced inducement equity awards for six newly hired employees under its 2025 Inducement Equity Incentive Plan on February 9 and February 11, 2026.
Five employees received options for an aggregate 147,213 shares on February 9 at an exercise price of $13.48; one employee received 5,125 shares on February 11 at $12.67. Options vest over four years (25% after one year, then monthly 1/48th), with exercise prices equal to the closing share price on each grant date, and were granted as inducements under Nasdaq Listing Rule 5635(c)(4).
Aardvark Therapeutics (Nasdaq: AARD) announced on Feb 12, 2026 the creation of a wholly owned U.S. subsidiary, Ardia Therapeutics, to advance a dermatology pipeline led by DIA-615, a potential topical treatment for inflammatory skin diseases including psoriasis.
Bryan Jones, Ph.D., has been named CEO of Ardia and has transitioned from his role as Aardvark COO; management tenure and prior program experience were noted.
Aardvark Therapeutics (Nasdaq: AARD) announced leadership appointments effective February 9, 2026: Derrick C. Li named Chief Business Officer and Nelson Sun’s role expanded to Chief Operating Officer in addition to Chief Financial Officer.
The company said these moves coincide with continued development of ARD-201 (Phase 2) and with ARD-101 progressing to Phase 3, with topline Phase 3 data expected in Q3 2026.
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.