Overview
- The FDA issued a full clinical hold that stops all studies of ARD-101, including the Phase 3 HERO trial and its open-label extension for Prader–Willi syndrome.
- Aardvark said it will unblind data from the HERO and extension studies to review safety and efficacy and to decide the program’s next steps.
- The move follows the company’s March pause after reversible heart findings in healthy volunteers given higher-than-planned doses, and shares fell about 14% after hours.
- ARD-101 is an oral small molecule that activates bitter taste receptors in the gut to trigger hormone release that can reduce extreme hunger.
- An investor investigation is reviewing whether Aardvark’s prior statements about safety, efficacy data, and FDA communications were proper after a sharp sell-off and analyst target cuts reported in March.