Earnings summaries and quarterly performance for Aardvark Therapeutics.
Research analysts covering Aardvark Therapeutics.
Recent press releases and 8-K filings for AARD.
Aardvark Therapeutics Updates on Clinical Programs and Financial Runway
AARD
New Projects/Investments
Guidance Update
- Aardvark Therapeutics, Inc. updated its corporate presentation on January 12, 2026, detailing its pipeline and strategic focus.
- The company's lead program, ARD-101, is in an ongoing Phase 3 HERO trial for hyperphagia in Prader-Willi Syndrome, with topline data expected in Q3 2026.
- Aardvark is also advancing ARD-201 for obesity, with the Phase 2 POWER trial initiated for weight maintenance and the Phase 2 STRENGTH trial expected to initiate in 1H 2026.
- The company's balance sheet is funded into 2027, supporting its development programs.
Jan 12, 2026, 1:30 PM
Aardvark Therapeutics Provides Update on ARD-101 Clinical Development
AARD
New Projects/Investments
- Aardvark Therapeutics is developing ARD-101, an oral small molecule drug, for Prader-Willi syndrome (PWS) and general obesity.
- The Phase 3 HERO trial for ARD-101 in PWS initiated in Q2 2025, with top-line data anticipated in Q3 2026; the primary endpoint is the HQ-CT9 hyperphagia score.
- In a Phase 2 obesity study, ARD-101 monotherapy demonstrated a 1.3 kg placebo-adjusted weight loss over 28 days.
- Preclinical data for an ARD-101 + Sitagliptin combination for obesity showed 19% body weight loss in a mouse model within 30 days, comparable to Tirzepatide.
Dec 4, 2025, 4:15 PM
Aardvark Therapeutics Provides Update on ARD-101 Clinical Development
AARD
New Projects/Investments
- Aardvark Therapeutics is advancing ARD-101, an oral small molecule, for Prader-Willi Syndrome (PWS) as a monotherapy and for general obesity in combination with Sitagliptin.
- The Phase 3 HERO trial for ARD-101 in PWS began in Q2 2025, targeting the HQ-CT9 hyperphagia score as its primary endpoint, with top-line data anticipated in Q3 2026.
- In a Phase 2 obesity study, ARD-101 monotherapy achieved a 1.3 kg weight loss (placebo difference) over 28 days in 20 subjects.
- Preclinical data for the ARD-101 plus Sitagliptin combination demonstrated 19% body weight loss in a high-fat-fed mouse model within 30 days, nearly matching Tirzepatide's 20.5%.
Dec 4, 2025, 4:15 PM
Aardvark Therapeutics Provides Updates on ARD-101 and ARD-201 Clinical Programs
AARD
New Projects/Investments
Guidance Update
- Aardvark Therapeutics is advancing ARD-101, a bitter taste receptor agonist, in a Phase 3 clinical trial for Prader-Willi syndrome, with top-line data expected in Q3 2026. The drug targets the gut-brain axis to dampen hunger and appetite, bypassing the hypothalamus to potentially reduce side effects like nausea.
- The company is initiating a Phase 2 clinical trial for ARD-201, a combination of ARD-101 and sitagliptin, for obesity. This program will investigate its use for weight maintenance after GLP-1 receptor agonist therapy and for weight induction in combination with GLP-1s, with preliminary data for the maintenance study anticipated by the end of next year (2026).
- The ongoing Phase 3 trial for ARD-101 in Prader-Willi syndrome includes patients 10 years and older and features an interim analysis for sample size re-estimation.
Dec 3, 2025, 1:00 PM
Aardvark Therapeutics Provides Updates on Prader-Willi Syndrome and Obesity Programs
AARD
New Projects/Investments
Guidance Update
- Aardvark Therapeutics, a publicly traded company founded in 2017, is focused on developing oral small molecule drugs that target gut-brain signaling to reduce hunger.
- The company's lead program, ARD-101, is in a Phase III HERO trial for Prader-Willi syndrome, with top-line results anticipated in Q3 2026. ARD-101 has demonstrated a very tolerable safety profile in Phase I and II studies, with no more than grade two transient adverse events observed in over 70 patients.
- For general obesity, Aardvark is planning two Phase II trials for ARD-201 (a combination of ARD-101 and a DPP-4 inhibitor): the POWER trial (prevention of weight regain) is expected to start by the end of 2025 with a readout in the second half of 2026, and the STRENGTH trial (prospective weight loss) is slated to begin in the first half of 2026. Preclinical data for ARD-201 showed 19% body weight loss in 30 days, comparable to high-dose tirzepatide, and a synergistic effect with low-dose tirzepatide resulted in 30% weight loss in 30 days.
- Aardvark is also exploring ARD-868, an early-stage, muscle-preserving program for weight loss that is orthogonal to GLP-1s, and is currently seeking partnering opportunities.
Nov 24, 2025, 8:00 PM
Aardvark Therapeutics Reports Q3 2025 Financial Results and Pipeline Updates
AARD
Earnings
New Projects/Investments
Guidance Update
- Aardvark Therapeutics reported a net loss of $16.3 million for the third quarter ended September 30, 2025, compared to a net loss of $4.2 million for the same period in 2024, primarily due to increased research and development and general and administrative expenses.
- As of September 30, 2025, the company held $126.4 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into 2027.
- The FDA aligned with Aardvark to reduce the minimum age of eligibility for pediatric patients in the Phase 3 HERO trial (ARD-101) for Prader-Willi Syndrome from 13 to 10 years old.
- New preclinical data for ARD-201 was presented at ObesityWeek 2025, demonstrating its potential in enhanced glucose control and preservation of lean body mass, with plans to advance it into two Phase 2 trials.
- Key upcoming milestones include topline data from the Phase 3 HERO trial expected in Q3 2026 and preliminary data from the Phase 2 POWER trial anticipated in 2H 2026.
Nov 13, 2025, 9:20 PM
Aardvark Therapeutics Provides Update on ARD-101 and ARD-201 Programs
AARD
Product Launch
New Projects/Investments
Guidance Update
- Aardvark Therapeutics' lead program, ARD-101, an oral small molecule for Prader-Willi syndrome, is currently in its Phase 3 HERO trial, with top-line results anticipated in Q3 2026.
- Phase 2 data for ARD-101 in Prader-Willi syndrome demonstrated a minus eight HQCT reduction over 28 days, which is considered a significant benefit compared to typical placebo responses.
- The company's obesity program, ARD-201 (a combination of ARD-101 and sitagliptin), showed promising preclinical results, achieving 19% weight loss at 30 days in a high-fat-fed mouse model, comparable to high-dose tirzepatide.
- Aardvark Therapeutics plans to partner out the ARD-201 asset for obesity, while intending to advance ARD-101 for Prader-Willi syndrome independently.
- The composition of matter intellectual property for ARD-101 is protected until 2038.
Nov 11, 2025, 9:40 PM
Aardvark Therapeutics, Inc. Hosts Investor Webinar on ARD-101 and ARD-201 Programs
AARD
New Projects/Investments
Guidance Update
- Aardvark Therapeutics, Inc. held an investor webinar on November 5, 2025, to review its ARD-101 and ARD-201 programs and ObesityWeek 2025 presentations.
- The Phase 3 HERO trial for ARD-101 in Prader-Willi Syndrome is ongoing, with topline results anticipated in Q3 2026.
- Two Phase 2 trials for ARD-201 in obesity are expected to initiate: the POWER TRIAL (Weight Maintenance) in 2H 2025 and the STRENGTH TRIAL (Weight Loss) in 1H 2026.
- The company's balance sheet indicates it is funded into 2027.
Nov 5, 2025, 11:11 PM
AARD Provides Updates on Metabolic Obesity and Prader-Willi Syndrome Programs
AARD
New Projects/Investments
Guidance Update
- AARD provided updates on its metabolic obesity programs, ARD201 and WE868, and its Prader-Willi syndrome program, ARD101.
- ARD201, a fixed-dose combination, demonstrated 19% weight loss in 30 days in preclinical studies, preserved prior weight loss post-GLP-1 withdrawal, and spared lean mass.
- The company is advancing three clinical trials: the HERO phase 3 study for ARD101 (Prader-Willi syndrome), the POWER study for ARD201 (prevent weight regain), and the STRENGTH trial for ARD201 (weight loss induction).
- Top-line data for the HERO clinical trial (ARD101) is anticipated in Q3 2026, and preliminary data for the POWER trial (ARD201) is expected in H2 2026.
- Preclinical data for WE868, a new program for metabolic obesity, showed an average of 10.3% weight loss in a prior Phase 1B oncology study.
Nov 5, 2025, 10:00 PM
Aardvark Therapeutics Presents Obesity Pipeline Data and Future Trial Plans at ObesityWeek 2025
AARD
New Projects/Investments
Guidance Update
- Aardvark Therapeutics presented data on its metabolic obesity pipeline programs, ARD-201 and WE-868, at the ObesityWeek 2025 conference on November 4, 2025.
- ARD-201, a planned fixed-dose combination of ARD-101 and sitagliptin, demonstrated preclinical efficacy including ~19% body weight reduction in DIO mice comparable to high-dose tirzepatide, and the ability to mitigate weight regain after GLP-1RA discontinuation.
- The company plans to initiate two Phase 2 trials for ARD-201: the POWER trial by the end of 2025 and the STRENGTH trial in the first half of 2026.
- WE-868, an isoflavonoid modulator, showed significant weight loss in preclinical studies, including against semaglutide in DIO mice, and an average body weight loss of >10% in a clinical study for another indication.
- An investor webinar is scheduled for November 5, 2025, to discuss these programs and the ObesityWeek presentations.
Nov 4, 2025, 9:19 PM
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