Federal health regulators have issued a complete clinical hold on an experimental medication developed by Aardvark Therapeutics to address excessive appetite associated with Prader-Willi syndrome, effectively stopping all advanced-stage testing.
The company’s stock price dropped approximately 14% during after-hours trading following the announcement.
Aardvark had previously suspended patient enrollment and medication administration in February after discovering cardiac complications in healthy study participants who received doses of ARD-101 that exceeded planned levels.
The U.S. Food and Drug Administration’s clinical hold encompasses all research involving ARD-101, including both a late-stage trial and an extension study focused on Prader-Willi syndrome.
According to the company, this regulatory action comes after their previously announced voluntary suspension, and they are currently engaged in ongoing conversations with the FDA to address the safety concerns.
The pharmaceutical developer reported that 68 patients had received the medication in the primary study and 19 participants in the extension trial by the end of February.
Company officials stated they plan to examine study information to evaluate both safety and effectiveness before determining their next course of action.
ARD-101, designed as an oral treatment, functions by stimulating intestinal hormones through the activation of taste receptors.
Aardvark reported having $91.2 million in cash and investments at the end of March, which the company projects will support operations through mid-2027.
