Why Aardvark Therapeutics (AARD) Paused Late-Stage ARD-101 Trials After Cardiac Findings

Aardvark Therapeutics, Inc. (NASDAQ:AARD) is one of the penny stocks with potential to rise 1000 percent.

Aardvark Therapeutics said on March 23, 2026, that it had voluntarily paused its Phase 3 HERO and open-label extension trials of ARD-101 in Prader-Willi syndrome, as well as the ARD-201 obesity program, while it works with the FDA on next steps. The company said it expects to provide further guidance on both programs in the second quarter of 2026.

The update was driven by cardiac findings from a separate healthy volunteer study, not from prior Prader-Willi syndrome trials. Aardvark said two of eight participants in a healthy volunteer cohort dosed at 1,600 mg twice daily without prior dose escalation had QRS increases greater than 25% from baseline, while another had an increase below that threshold. In a follow-on healthy volunteer cohort dosed at 800 mg twice daily for up to one week, one of 23 participants had a transient QRS increase of less than 25% from baseline, and another had an increase greater than 25%. The company said these observations were reversible, were not reported as serious adverse events, and were not accompanied by serious cardiac symptoms.

Aardvark said preliminary analysis showed a clear exposure-response relationship, with higher plasma concentrations associated with a higher risk of QRS prolongation. It added that ARD-101 data were published in Molecular Metabolism in March. The company ended 2025 with $110.0 million in cash, cash equivalents, and short-term investments, which it said should fund operations into the second quarter of 2027.

Aardvark Therapeutics, Inc. (NASDAQ:AARD) is a clinical-stage biopharmaceutical company developing small-molecule therapies designed to suppress hunger in Prader-Willi syndrome and metabolic diseases.

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