Aardvark's Hunger-Suppressing Drug Promises Weight Loss Without GI Distress

HC Wainwright initiated coverage on Aardvark Therapeutics, Inc. (NASDAQ:AARD) on Monday with a Buy rating and a price forecast of $40.

In February, Aardvark Therapeutics, Inc. (NASDAQ:AARD) priced an initial public offering of 5.9 million at $16 per share, with approximately $94.2 million in gross proceeds.

Aardvark is a clinical-stage biopharmaceutical company that develops novel, small-molecule therapeutics to activate innate homeostatic pathways for metabolic diseases.

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Aardvark’s lead product candidate, ARD-101, targets Bitter Taste Receptors (TAS2Rs) expressed in the gut lumen, inducing secretion of endogenous signaling molecules, including the satiety hormone cholecystokinin (CCK), which in turn activates gut-brain signals to suppress the sensation of hunger.

Unlike many existing obesity treatments that act systemically and can cause significant gastrointestinal (GI) side effects like nausea, vomiting, and diarrhea, ARD-101 targets specific receptors in the gut.

ARD-101 aims to reduce hunger and facilitate weight loss without the typical systemic side effects. Importantly, its gut-restricted nature means minimal systemic exposure, potentially minimizing off-target effects and preserving lean muscle mass, which is a common concern with some weight loss methods.

The drug candidate has entered Phase 3 development for hyperphagia associated with Prader-Willi Syndrome. Data readout is expected in early 2026. The company holds Orphan Drug Designation for ARD-101 in PWS.

Aardvark believes that its existing cash, cash equivalents, and short-term investments, together with the proceeds from the IPO, will be sufficient to fund projected operations into 2027.

Analyst Raghuram Selvaraju noted that there is only one branded medication currently approved in PWS, namely, Vykat XR (diazoxide choline extended-release), launched in April 2025, which has a list price of over $466K in the U.S.

Accordingly, the analyst feels that the pricing and competitive landscape dynamics appear favorable, even if the target patient population is small (roughly 20K patients in the U.S.)

FDA approved Soleno Therapeutics, Inc.'s (NASDAQ:SLNO) Vykat XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for hyperphagia in adults and children 4 years of age and older with PWS.

Selvaraju believes that “ARD-101 could achieve robust market share even if it does not have comparable or superior efficacy to existing approved agents, if it proves the hypothesis that the mechanism of action ought to yield significantly better safety and tolerability (particularly with respect to GI side effects).”

Beyond Prader-Willi Syndrome, ARD-101 is also being evaluated in the Phase 2 HONOR trial for patients with hypothalamic obesity (HO). The analyst views ARD-101 as an “intriguing treatment alternative for HO patients because of its oral route of administration and benign safety profile.” Hypothalamic obesity is a challenging condition with limited approved treatments.

Price Action: AARD stock was up 4.11% at $13.94 at last check Monday.

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