Aardvark Therapeutics, Inc.
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Background
On February 27, 2026, Aardvark issued a press release “announc[ing] it is voluntarily pausing the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial” due to a “reversible cardiac observations at above target therapeutic doses found during routine safety monitoring in a healthy volunteer study” and said that it is “conducting a comprehensive review of the data to inform next steps.”
On this news, Aardvark’s stock price fell $7.02 per share, or 56.2%, to close at $5.47 per share on March 2, 2026, thereby injuring investors.
Then, on May 14, 2026, Aardvark issued a press release “announc[ing] that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101 related to the Company’s previously announced voluntary pause.” The press release stated “[t]he clinical hold applies to all ongoing clinical studies under the IND, including the Phase 3 HERO trial (AVK-101-301… and the Phase 3 open-label extension (OLE) trial (AVK-101-302).”
On this news, Aardvark’s stock price fell $2.16 per share, or 32.1%, to close at $4.57 per share on May 15, 2026, thereby injuring investors.
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