Aardvark Therapeutics stock rating cut to Perform by Oppenheimer

Oppenheimer has downgraded Aardvark Therapeutics Inc (NASDAQ:AARD) to a "Perform" rating from "Outperform" and eliminated its $21 price target. The stock has plummeted 63% in a single week, reaching $0.98, and now trades near its lowest price in 52 weeks with a market value of $30.4 million. This decision follows Aardvark's announcement that the clinical hold on ARD-101 was lifted and the release of preliminary data from the prematurely terminated Phase 3 HERO study.

Oppenheimer believes the results may hint at a therapeutic impact on hyperphagia, but they remain speculative. The cardiac safety data suggests resuming clinical trials at lower doses than the Phase 3 target of 800mg twice daily, which has shown promise in earlier open-label studies. However, Aardvark is rapidly depleting its cash reserves, and it is projected that the company will run out of funds by 2027.

The firm intends to seek FDA input on a reworked Phase 3 study design and anticipates resuming trials for Prader-Willi Syndrome in 2027. Oppenheimer raised several uncertainties, including the potential need for cardiac monitoring in future studies, label limitations, mitigation strategies, and questions about efficacy.