Aardvark expands PWS trial to include younger patients aged 10-12

SAN DIEGO - Aardvark Therapeutics (NASDAQ:AARD), whose stock has surged over 18% in the past week and is currently trading at $17.41, has received FDA alignment to lower the minimum age requirement in its Phase 3 HERO trial for Prader-Willi Syndrome (PWS) from 13 to 10 years old, the company announced Wednesday. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt.

The protocol amendment for ARD-101, which treats hyperphagia (excessive hunger) associated with PWS, will broaden the eligible patient population for the clinical trial.

"Expansion of the Phase 3 HERO trial to include children 10 years of age and older will allow us to reach a larger segment of the PWS patient population to potentially serve more patients in need," said Tien Lee, Founder and Chief Executive Officer of Aardvark.

The decision was influenced by support from the PWS community and historical data suggesting younger patients may benefit from earlier intervention, according to the company’s press release statement.

ARD-101 is a gut-restricted small molecule that activates select taste receptors in the intestinal lumen, stimulating the release of gut-peptide hormones that regulate hunger. The drug has previously received both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for PWS.

Aardvark expects topline data from the Phase 3 HERO trial in the third quarter of 2026. The company is also developing ARD-201, a combination therapy of ARD-101 with a DPP-4 inhibitor, targeting obesity and related conditions.

Prader-Willi Syndrome is a rare genetic disorder characterized by insatiable hunger, which ARD-101 aims to address through its mechanism of suppressing hunger signals. With a market capitalization of $377.74 million and an overall Financial Health score rated as GREAT by InvestingPro, Aardvark appears well-positioned to advance its clinical programs.

In other recent news, Aardvark Therapeutics has been the subject of multiple analyst evaluations. Jones Trading initiated coverage on the company with a Buy rating and set a price target of $33.00. H.C. Wainwright reiterated its Buy rating and maintained a $40.00 price target, following Pfizer’s announcement of acquiring Metsera. Cantor Fitzgerald also reiterated its Overweight rating with a $50.00 price target, highlighting the company’s market capitalization and suggesting potential upside for investors. However, RBC Capital lowered its price target on Aardvark Therapeutics to $19.00, citing delays in the company’s clinical plans, including a postponed Phase III trial for its ARD-101 drug in Prader-Willi syndrome. Despite this, RBC Capital maintained an Outperform rating on the stock. These recent developments provide a mixed outlook on Aardvark Therapeutics, with differing opinions on its future potential.

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