Aardvark Therapeutics, Inc. (NASDAQ:AARD) is a clinical-stage biopharmaceutical company developing small-molecule therapeutics designed to suppress hunger for Prader-Willi Syndrome (PWS) and metabolic diseases.
Lead compound, oral ARD-101, is in Phase 3 clinical development for hyperphagia associated with PWS, a rare disease characterized by insatiable hunger.
On Wednesday, Aardvark Therapeutics dosed the first patient in Australia in its Phase 3 HERO clinical trial assessing ARD-101.
Additionally, regulatory clearance for enrollment by clinical trial sites in Canada and the United Kingdom has also been received.
Also Read: Aardvark’s Hunger-Suppressing Drug Promises Weight Loss Without GI Distress
William Blair initiated coverage on Aardvark Therapeutics with an Outperform rating.
Based on strong enrollment in the U.S. and continued progress in advancing the clinical trial internationally, the clinical trial continues to track towards a topline data readout in the third quarter of 2026.
The global total addressable market (TAM) for PWS, according to William Blair’s estimates, is roughly $10 billion, and there is currently only one approved treatment.
Analyst Andy Hsieh says this opportunity alone justifies its valuation framework.
Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a DPP-4 inhibitor, and conducting two separate trials to address some of the limitations of currently marketed GLP-1 therapies for the treatment of obesity and obesity-related conditions.
ARD-201’s TAM could reach at least $100 billion, and serve as an oral and more tolerable alternative to GLP-1RAs, and both maintenance and induction settings are being investigated, offering investors multiple shots on goal.
William Blair says there is an appreciable disconnect between the current market value of $304 million and the potential of lead program ARD-101.
Aardvark had cash, cash equivalents, and short-term investments of $126.4 million, which will be sufficient to fund projected operations into 2027.
AARD Price Action: Aardvark Therapeutics shares were down 6.28% at $14.63 at the time of publication on Friday, according to Benzinga Pro data.
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