Aardvark Therapeutics Aligns with FDA on Trial Amendment

Aardvark Therapeutics, Inc. ( (AARD) ) has shared an announcement.

On October 8, 2025, Aardvark Therapeutics announced an alignment with the U.S. FDA on a protocol amendment for its Phase 3 HERO trial of ARD-101, aimed at treating hyperphagia associated with Prader-Willi Syndrome. The amendment lowers the minimum age of trial participants from 13 to 10 years, potentially expanding the patient population and addressing the needs of younger patients who may benefit from early intervention. This strategic move, supported by the PWS community, is expected to enhance the company’s positioning in the biopharmaceutical industry, with topline data anticipated in the third quarter of 2026.

The most recent analyst rating on (AARD) stock is a Buy with a $33.00 price target. To see the full list of analyst forecasts on Aardvark Therapeutics, Inc. stock, see the AARD Stock Forecast page.

Spark’s Take on AARD Stock

According to Spark, TipRanks’ AI Analyst, AARD is a Underperform.

Aardvark Therapeutics, Inc. faces severe financial challenges typical of early-stage pharmaceutical companies, with zero revenue and substantial operational losses. The lack of technical and valuation indicators further contributes to the high-risk profile.

To see Spark’s full report on AARD stock, click here.

More about Aardvark Therapeutics, Inc.

Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases. The company is particularly focused on addressing hunger-related conditions such as Prader-Willi Syndrome and is developing ARD-101, a gut-restricted small molecule agonist, and ARD-201, a combination therapy for obesity-related conditions.

Average Trading Volume: 123,586

Technical Sentiment Signal: Strong Buy

Current Market Cap: $377.7M

Learn more about AARD stock on TipRanks’ Stock Analysis page.