Aardvark Therapeutics Pauses Key Phase 3 Trial for ARD-101 Due to Cardiac Safety Observations
AARD sits 33% above its 52-week low of $4.88 on elevated volume (2.0× avg).
Summary
Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial for ARD-101 in Prader-Willi Syndrome due to cardiac safety observations, delaying topline data.
Key Events · Product Development and Regulatory · AARD
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Phase 3 Trial Paused
Aardvark Therapeutics has voluntarily paused its Phase 3 Hunger Elimination or Reduction Objective (HERO) trial for ARD-101, a lead candidate for Prader-Willi Syndrome.
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Cardiac Safety Concerns Identified
The decision to pause was based on reversible cardiac observations found during routine safety monitoring in a healthy volunteer study, occurring at above target therapeutic doses.
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Topline Data Delayed
Topline data from the HERO trial, previously anticipated in the third quarter of 2026, is no longer expected then. The company expects to provide further guidance in the second quarter of this year.
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Impact on Lead Program
This represents a significant setback for the company's primary clinical asset, ARD-101, which had recently received IRB approval to expand trial eligibility on February 10, 2026.
Analysis · AARD · Life Sciences
This filing announces a significant setback for Aardvark Therapeutics' lead clinical program, ARD-101, which is in Phase 3 for Prader-Willi Syndrome. The voluntary pause of the HERO trial, prompted by reversible cardiac observations in a healthy volunteer study, introduces substantial uncertainty regarding the drug's safety profile and development timeline. This directly reverses the positive momentum from the IRB approval to expand trial eligibility announced on February 10, 2026. Investors should anticipate a delay in topline data, previously expected in Q3 2026, and monitor for further guidance in Q2 2026 regarding the company's path forward for ARD-101.
At the time of this filing, AARD was trading at $6.50 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $271.9M. The 52-week trading range was $4.88 to $17.94. This filing was assessed with negative market sentiment and an importance score of 9 out of 10.