Aardvark Therapeutics Reports Exploratory Data from the Terminated HERO and Open-Label Extension Trials
Early termination leaves efficacy findings exploratory, while a lifted clinical hold allows planning for a new Phase 3 program.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Aardvark Therapeutics (Nasdaq: AARD) reported exploratory ARD-101 efficacy and safety data from its terminated HERO and open-label extension trials.
HERO randomized 67 of 90 planned participants; early termination prevents definitive efficacy conclusions. Hunger questionnaire scores showed a modest reduction versus placebo at Week 2. Scores returned near baseline within two weeks of stopping ARD-101, with less rebound on placebo. Extension participants switching from placebo had an average 6-point reduction by Day 28. Most adverse events were mild to moderate, but one cardiac serious adverse event was linked to a drug interaction. The FDA lifted the clinical hold on October 22, 2026. Aardvark plans an FDA meeting on a new Phase 3 design and lower-dose resumption, pending FDA discussion, and expects to resume PWS clinical activities in 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointFDA lifted the ARD-101 clinical hold for hyperphagia in Prader-Willi syndrome on October 22, 2026.
- Moderate point. Forward-looking: it has not happened yet and may not happen.New Phase 3 program is planned for FDA discussion; Aardvark expects PWS clinical activities to resume in 2027.
- Minor pointWeek 2 hunger questionnaire scores showed a modest exploratory reduction on ARD-101 versus placebo during dose escalation.
- Minor point6-point average hunger questionnaire reduction occurred by Day 28 in extension participants switching from placebo to ARD-101.
- Minor pointCaregiver and clinician assessments showed a similar exploratory pattern to hunger questionnaire results.
- Minor pointARD-101 was generally well tolerated, with most adverse events mild to moderate.
Negative
- Moderate pointHERO terminated early after randomizing 67 of 90 planned participants; all efficacy data remain exploratory, without definitive conclusions.
- Minor pointOne cardiac serious adverse event occurred at 800 mg twice daily with concomitant pitolisant; FDA concurred on a drug-drug interaction.
- Minor pointHunger questionnaire scores returned near baseline within two weeks of stopping ARD-101; placebo showed less rebound.
- Minor pointLower-dose ARD-101 resumption, below 800 mg twice daily, remains pending FDA discussion.
Details
Market move: AARD -11.90% vs previous close. Phase 3 clinical data
On Oct 23, the day this news came out, the latest delayed price for AARD is 11.90% below the previous close. Argus tracked a trough of -49.0% from its starting point during tracking. Our momentum scanner has recorded 25 alerts for this stock so far that day. The latest delayed price is $3.48. Relative volume is exceptionally heavy at 21.1x the average.
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Key Figures
- Participants randomized
- 67 of 90 planned participants
- HERO trial; terminated early
- HQ-CT score reduction
- 6 points
- OLE participants switching from placebo to ARD-101
- Cardiac serious adverse event
- 1 event at 800 mg twice daily
- HERO trial; participant was also taking pitolisant
- Clinical hold lifted
- October 22, 2026
- FDA lifted the hold on the ARD-101 Investigational New Drug application
- Planned resumption
- 2027
- Company expects to resume PWS clinical activities
Historical Context
-
Trials had been terminated, data review was underway, and the clinical hold remained unresolved.
-
FDA placed a full clinical hold on ARD-101, and Aardvark planned to unblind existing trial data.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
open-label extension technical
cyp2d6 substrate medical
drug-drug interaction medical
investigational new drug application regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- HERO trial terminated early (67 of 90 planned participants randomized); all efficacy data are considered exploratory
- HQ-CT scores fell by Week 2 of dose escalation on ARD-101 and returned to near baseline within two weeks of stopping treatment, with less rebound on placebo
- OLE participants switching from placebo to ARD-101 saw a further reduction in HQ-CT scores by Day 28
- ARD-101 was well tolerated; most adverse events mild to moderate
- FDA lifted full clinical hold on ARD-101; Company plans to request FDA meeting to align on new Phase 3 trial design and expects to resume PWS clinical activities in 2027
- Conference call and webcast today at 8:00 a.m. ET
SAN DIEGO, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark or the Company) (Nasdaq: AARD), a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi syndrome (PWS) and metabolic diseases, today reported exploratory efficacy data from its previously terminated Phase 3 Hunger Elimination or Reduction Objective (HERO) trial and open-label extension (OLE) trial. As previously announced, Aardvark unblinded the data accumulated across both the HERO trial and OLE trial to assess the totality of available efficacy and safety data to inform the path forward for ARD-101.
“Though the HERO trial was stopped early and the current partial data are not sufficient to draw definitive conclusions, we believe these exploratory efficacy and safety data are directionally consistent and give us confidence in the continued development of ARD-101 for the treatment of PWS. We look forward to continuing to work closely with the FDA and plan to request a meeting to align on the design of a new Phase 3 trial intended to support a future marketing application, with the important goal of delivering this potential treatment option to patients in need,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “Hyperphagia is one of the most challenging aspects of PWS for patients and their families, and we believe there remains a significant need for additional treatment options that can meaningfully reduce the constant, life-limiting hunger that defines this disease.”
A summary of the available dataset from the Phase 3 HERO trial and OLE trial can be found below. The HERO trial randomized 67 of the planned 90 participants and was terminated early. As such, all efficacy data are considered exploratory.
- At week two of dose escalation on ARD-101, a modest reduction in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score versus placebo was observed in the HERO trial.
- Upon discontinuation of ARD-101, the average HQ-CT score of the ARD-101 treatment group returned to near baseline, while the placebo-treated group had less rebound toward baseline.
- In the OLE cohort, participants who switched from placebo to ARD-101 had an observed average reduction of 6 points in HQ-CT score.
- A similar pattern was observed for caregiver and clinician outcome measures, assessed by Caregiver Global Impression and Clinician Global Impression Severity scores, respectively.
- ARD-101 was generally well tolerated, with most adverse events being mild to moderate.
- One cardiac serious adverse event was observed in the HERO trial at 800 mg twice daily (BID) in a participant who was also taking pitolisant, a CYP2D6 substrate. The U.S. Food and Drug Administration (FDA) concurred that this event is related to a drug-drug interaction.
Aardvark plans to resume dosing of ARD-101 in patients with PWS at a dose lower than the 800 mg BID dose studied in the Phase 3 HERO trial and OLE trial, pending discussion with the FDA. The Company plans to request a meeting with the FDA to align on its Phase 3 program, with the goal of advancing ARD-101 toward potential regulatory approval.
As previously announced on October 22, 2026, the FDA has lifted the clinical hold on the Company’s Investigational New Drug application for ARD-101 for the treatment of hyperphagia in PWS.
Conference Call and Webcast
The Company will host a live conference call and webcast for investors to discuss data from the HERO and OLE trials today, October 23, 2026, at 8:00 a.m. ET. To access the live webcast, participants may register here. To access the subsequent archived recording of this event, please visit the Investors section of Aardvark’s website.
About ARD-101
ARD-101 is an oral, small-molecule therapeutic designed to stimulate the release of gut-peptide hormones through activation of bitter taste receptors. ARD-101 is being developed as a treatment for hyperphagia associated with Prader-Willi Syndrome, a rare genetic disorder characterized by insatiable hunger.
About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. For more information, visit www.aardvarktherapeutics.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy, product candidates, the path forward for ARD-101, including the anticipated resumption of dosing of ARD-101 in patients with PWS and anticipated doses to be used in future trials, the timing for resuming clinical activities, and Aardvark’s planned engagement with the FDA regarding its Phase 3 program and the potential for any future Phase 3 trial to support a future marketing application or regulatory approval, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the risk that the FDA may not agree with Aardvark’s proposed Phase 3 program or may require additional studies; the timing of resuming dosing and activating clinical sites; the risk of additional safety findings, including risks related to cardiac safety and drug-drug interactions; limitations in interpreting data from the HERO trial and its OLE trial, which were terminated early and were not powered to assess efficacy; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; the risk that Aardvark may use its capital resources sooner than expected; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the Securities and Exchange Commission on August 11, 2026. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.
Investor and Media Contact
Argot Partners
(212) 600-1902
Aardvark@Argotpartners.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Aardvark's terminated HERO and extension trials show for ARD-101?
ARD-101 showed a modest exploratory reduction versus placebo in hunger questionnaire scores at Week 2 of dose escalation, while extension participants switching from placebo had an average 6-point reduction by Day 28. HERO stopped after randomizing 67 of 90 planned participants, so the partial efficacy data do not support definitive conclusions.
What is Aardvark planning after the FDA lifted the ARD-101 clinical hold?
Aardvark plans to request an FDA meeting to align on a new Phase 3 trial design and expects to resume Prader-Willi syndrome clinical activities in 2027. Resuming dosing below the 800 mg twice-daily dose studied in HERO and the extension remains pending discussion with the FDA.
What cardiac safety event occurred in Aardvark's HERO trial?
One cardiac serious adverse event occurred at 800 mg twice daily in a participant also taking pitolisant, a CYP2D6 substrate. The FDA concurred that the event was related to a drug-drug interaction. ARD-101 was generally well tolerated overall, with most adverse events mild to moderate.