Pomerantz investigates Aardvark Therapeutics amid FDA clinical hold
Pomerantz LLP is investigating Aardvark Therapeutics for potential securities fraud following a series of negative developments. The company's stock plummeted 56.2% in March after pausing its Phase 3 HERO trial due to cardiac safety concerns and fell another 32.1% in May after the FDA imposed a full clinical hold on the ARD-101 IND.
*this image is generated using AI for illustrative purposes only.
Pomerantz LLP is investigating claims on behalf of investors of Aardvark Therapeutics, Inc. concerning potential securities fraud or other unlawful business practices by the company and its officers. The investigation follows significant stock declines triggered by clinical trial setbacks and regulatory actions affecting the company's lead drug candidate, ARD-101.
On February 27, 2026, Aardvark announced a voluntary pause of the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial. The company attributed the decision to reversible cardiac observations at above-target therapeutic doses found during routine safety monitoring in a healthy volunteer study. Consequently, Aardvark halted ongoing enrollment and dosing while conducting a comprehensive data review.
Following this announcement, Aardvark's stock price fell $7.02 per share, or 56.2%, to close at $5.47 per share on March 2, 2026.
Subsequently, on May 14, 2026, Aardvark disclosed that the U.S. Food and Drug Administration (FDA) placed a full clinical hold on its investigational new drug application (IND) for ARD-101. This hold applies to all ongoing clinical studies under the IND, including the Phase 3 HERO trial (AVK-101-301) evaluating ARD-101 for hyperphagia in patients with Prader-Willi Syndrome (PWS) and the Phase 3 open-label extension (OLE) trial (AVK-101-302).
On the news of the FDA clinical hold, Aardvark's stock price declined $2.16 per share, or 32.1%, to close at $4.57 per share on May 15, 2026.
Key Stock Movements
| Date | Event | Price Change | % Change | Closing Price |
|---|---|---|---|---|
| March 2, 2026 | HERO trial pause announcement | -$7.02 | -56.2% | $5.47 |
| May 15, 2026 | FDA clinical hold announcement | -$2.16 | -32.1% | $4.57 |
Investors are advised to contact Danielle Peyton at Pomerantz LLP regarding the investigation.
What specific data or protocol modifications will Aardvark need to present to the FDA to lift the clinical hold on ARD-101?
Does the company have sufficient cash reserves to sustain operations during the extended clinical hold and investigation?
How might the cardiac safety concerns identified in healthy volunteers impact the risk-benefit profile for patients with Prader-Willi Syndrome?
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