Aardvark Receives IRB Approval to Lower Age for HERO Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 10 2026
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Should l Buy AARD?
Source: Newsfilter
- Trial Expansion: Aardvark Therapeutics announced that its Phase 3 HERO clinical trial has received IRB approval to include children aged 7 and older, aiming to broaden the recruitment of Prader-Willi Syndrome patients and enhance the potential impact of the treatment.
- Recruitment Progress: CEO Tien Lee stated that enrollment in the HERO trial is progressing steadily, with topline data expected in the third quarter of 2026, which will further validate ARD-101's role in treating hyperphagia associated with Prader-Willi Syndrome.
- Trial Design Details: The HERO trial plans to enroll 90 patients across the U.S., Australia, Canada, the UK, and South Korea, with the primary endpoint being the change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score over 12 weeks, reflecting the company's commitment to clinical outcomes.
- Drug Background Information: ARD-101 is a small molecule agonist that has received FDA Orphan Drug and Rare Pediatric Disease designations, demonstrating potential in hunger suppression, particularly when used in conjunction with existing GLP-1 therapies, offering new treatment options for Prader-Willi Syndrome patients.
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Analyst Views on AARD
Wall Street analysts forecast AARD stock price to rise
10 Analyst Rating
10 Buy
0 Hold
0 Sell
Strong Buy
Current: 12.500
Low
18.00
Averages
33.00
High
50.00
Current: 12.500
Low
18.00
Averages
33.00
High
50.00
About AARD
Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases. The Company targets biological pathways associated with alleviating hunger that has the potential to deliver transformative outcomes for patients. It is focused on developing selective compounds, targeting Bitter Taste Receptors (TAS2Rs) for hunger-associated conditions. Its initial compounds target TAS2Rs expressed in the gut lumen, which normally respond to the nutrients in food and participate in the gut-brain axis. Its wholly owned lead product candidate, ARD-101 (denatonium acetate monohydrate), is an oral gut-restricted small-molecule agonist of certain TAS2Rs expressed in the gut lumen for which it has initiated a Phase III clinical trial for hyperphagia associated with Prader-Willi Syndrome (PWS).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
AARDVARK THERAPEUTICS INC - TEMPORARY HALT CAUSED BY CARDIAC FINDINGS AT ELEVATED DOSES
- Cardiac Observations: The therapeutic use of a certain treatment has been paused due to cardiac observations noted at above target doses.
- Safety Concerns: The decision to pause is likely driven by safety concerns related to the cardiac effects observed in patients.
See More
AARDVARK THERAPEUTICS: TEMPORARY SUSPENSION OF HERO & OPEN-LABEL EXTENSION TRIALS DUE TO REVERSIBLE CARDIAC FINDINGS AT EXCEEDING TARGET DOSES
Trial Overview: The article discusses the HERO and Open-Label Extension trials related to a therapeutic intervention.
Observations: It highlights that the trials are based on reversible cardiac observations above target doses.
See More
Aardvark Therapeutics Faces Investigation After Trial Pause
- Investigation Launched: The Schall Law Firm is investigating Aardvark Therapeutics for potential violations of securities laws, focusing on whether the company issued false or misleading statements and failed to disclose critical information to investors.
- Trial Pause Reason: Aardvark announced the pause of its late-stage trial for a rare disease treatment due to heart-related side effects observed in healthy volunteers receiving higher-than-planned doses, indicating the company's cautious approach to safety monitoring.
- Stock Price Plunge: Following this news, Aardvark's shares fell by over 47.3% in after-hours trading, reflecting strong investor concerns about the company's future prospects and potentially leading to a decline in investor confidence.
- Investor Rights Protection: The Schall Law Firm encourages affected investors to reach out to discuss their rights, demonstrating the firm's proactive stance in protecting investor interests, which may lead to further legal actions.
See More
Aardvark Therapeutics Pauses HERO Trial Amid Safety Concerns
- Trial Suspension Reason: Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial due to reversible cardiac observations identified during routine safety monitoring in a healthy volunteer study, indicating potential safety concerns at above-target therapeutic doses, prompting a comprehensive review of ARD-101's efficacy and safety.
- Data Release Delay: As a result of the trial suspension, Aardvark no longer expects to announce topline data from the HERO trial in Q3 2026, instead planning to provide updated guidance in Q2 of this year, reflecting the company's cautious approach to patient safety.
- Market Reaction: Aardvark's shares closed at $12.49, down $0.01 or 0.08% during regular trading, but sharply declined to $6.58 in after-hours trading, a drop of $5.91 or 47.32%, indicating market concerns regarding the company's future prospects.
- Enrollment and Dosing Halted: The company has suspended ongoing enrollment and dosing in the HERO trial while the evaluation is underway, demonstrating a strong commitment to clinical trial safety, which may impact its future R&D progress and market confidence.
See More
Aardvark Pauses PWS Trial, Shares Plunge 53%
- Trial Pause Reason: Aardvark Therapeutics announced a voluntary pause of its ARD-101 trial for Prader-Willi Syndrome due to cardiac observations in a healthy volunteer study, with data release now expected to be delayed until Q3 2026, potentially impacting the company's future R&D trajectory.
- Severe Market Reaction: Following the trial pause announcement, Aardvark's shares plunged 53% in after-hours trading, reflecting extreme investor concern over the company's outlook, which may lead to financing challenges and diminished market confidence.
- Competitor Dynamics: In contrast, Soleno Therapeutics' VYKAT XR has become the first FDA-approved treatment for hyperphagia in Prader-Willi Syndrome, despite facing short-selling pressure and safety concerns from Scorpion Capital, highlighting the intense competition in the market.
- Industry-Wide Challenges: Against the backdrop of Aardvark's trial pause, Acadia Pharmaceuticals also halted development of its intranasal Carbetocin, indicating that the challenges and risks associated with successful R&D in the Prader-Willi Syndrome treatment space are increasing, which could affect the overall investment attractiveness of the sector.
See More
Aardvark Therapeutics Grants Stock Options to New Employees
- Employee Incentive Program: Aardvark Therapeutics granted stock options totaling 152,338 shares to six new employees on February 9 and 11, 2026, aimed at attracting and retaining talent, thereby enhancing the company's competitive edge in the biopharmaceutical sector.
- Stock Option Details: The options were granted at exercise prices of $13.48 and $12.67, complying with Nasdaq Listing Rule 5635(c)(4), indicating the company's commitment to compliance and transparency in employee incentives.
- Long-Term Incentive Structure: Each option vests over four years, with 25% vesting in the first year and the remainder vesting monthly, designed to ensure employee commitment and stability, thus promoting sustained company growth.
- R&D Focus: Aardvark is dedicated to developing innovative therapies for metabolic diseases, particularly for Prader-Willi Syndrome, and the granting of stock options will help attract more specialized talent to advance its clinical trials and product development efforts.
See More
AARDVARK THERAPEUTICS INC - TEMPORARY HALT CAUSED BY CARDIAC FINDINGS AT ELEVATED DOSES
- Cardiac Observations: The therapeutic use of a certain treatment has been paused due to cardiac observations noted at above target doses.
- Safety Concerns: The decision to pause is likely driven by safety concerns related to the cardiac effects observed in patients.
See More
AARDVARK THERAPEUTICS: TEMPORARY SUSPENSION OF HERO & OPEN-LABEL EXTENSION TRIALS DUE TO REVERSIBLE CARDIAC FINDINGS AT EXCEEDING TARGET DOSES
Trial Overview: The article discusses the HERO and Open-Label Extension trials related to a therapeutic intervention.
Observations: It highlights that the trials are based on reversible cardiac observations above target doses.
See More
Aardvark Therapeutics Faces Investigation After Trial Pause
- Investigation Launched: The Schall Law Firm is investigating Aardvark Therapeutics for potential violations of securities laws, focusing on whether the company issued false or misleading statements and failed to disclose critical information to investors.
- Trial Pause Reason: Aardvark announced the pause of its late-stage trial for a rare disease treatment due to heart-related side effects observed in healthy volunteers receiving higher-than-planned doses, indicating the company's cautious approach to safety monitoring.
- Stock Price Plunge: Following this news, Aardvark's shares fell by over 47.3% in after-hours trading, reflecting strong investor concerns about the company's future prospects and potentially leading to a decline in investor confidence.
- Investor Rights Protection: The Schall Law Firm encourages affected investors to reach out to discuss their rights, demonstrating the firm's proactive stance in protecting investor interests, which may lead to further legal actions.
See More
Aardvark Therapeutics Pauses HERO Trial Amid Safety Concerns
- Trial Suspension Reason: Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial due to reversible cardiac observations identified during routine safety monitoring in a healthy volunteer study, indicating potential safety concerns at above-target therapeutic doses, prompting a comprehensive review of ARD-101's efficacy and safety.
- Data Release Delay: As a result of the trial suspension, Aardvark no longer expects to announce topline data from the HERO trial in Q3 2026, instead planning to provide updated guidance in Q2 of this year, reflecting the company's cautious approach to patient safety.
- Market Reaction: Aardvark's shares closed at $12.49, down $0.01 or 0.08% during regular trading, but sharply declined to $6.58 in after-hours trading, a drop of $5.91 or 47.32%, indicating market concerns regarding the company's future prospects.
- Enrollment and Dosing Halted: The company has suspended ongoing enrollment and dosing in the HERO trial while the evaluation is underway, demonstrating a strong commitment to clinical trial safety, which may impact its future R&D progress and market confidence.
See More
Aardvark Pauses PWS Trial, Shares Plunge 53%
- Trial Pause Reason: Aardvark Therapeutics announced a voluntary pause of its ARD-101 trial for Prader-Willi Syndrome due to cardiac observations in a healthy volunteer study, with data release now expected to be delayed until Q3 2026, potentially impacting the company's future R&D trajectory.
- Severe Market Reaction: Following the trial pause announcement, Aardvark's shares plunged 53% in after-hours trading, reflecting extreme investor concern over the company's outlook, which may lead to financing challenges and diminished market confidence.
- Competitor Dynamics: In contrast, Soleno Therapeutics' VYKAT XR has become the first FDA-approved treatment for hyperphagia in Prader-Willi Syndrome, despite facing short-selling pressure and safety concerns from Scorpion Capital, highlighting the intense competition in the market.
- Industry-Wide Challenges: Against the backdrop of Aardvark's trial pause, Acadia Pharmaceuticals also halted development of its intranasal Carbetocin, indicating that the challenges and risks associated with successful R&D in the Prader-Willi Syndrome treatment space are increasing, which could affect the overall investment attractiveness of the sector.
See More
Aardvark Therapeutics Grants Stock Options to New Employees
- Employee Incentive Program: Aardvark Therapeutics granted stock options totaling 152,338 shares to six new employees on February 9 and 11, 2026, aimed at attracting and retaining talent, thereby enhancing the company's competitive edge in the biopharmaceutical sector.
- Stock Option Details: The options were granted at exercise prices of $13.48 and $12.67, complying with Nasdaq Listing Rule 5635(c)(4), indicating the company's commitment to compliance and transparency in employee incentives.
- Long-Term Incentive Structure: Each option vests over four years, with 25% vesting in the first year and the remainder vesting monthly, designed to ensure employee commitment and stability, thus promoting sustained company growth.
- R&D Focus: Aardvark is dedicated to developing innovative therapies for metabolic diseases, particularly for Prader-Willi Syndrome, and the granting of stock options will help attract more specialized talent to advance its clinical trials and product development efforts.
See More
