Aardvark Expands PWS Phase 3 Trial to Younger Children

An update from Aardvark Therapeutics, Inc. ( (AARD) ) is now available.

On February 10, 2026, Aardvark Therapeutics announced that a U.S. Institutional Review Board approved an amended protocol for its ongoing Phase 3 HERO pivotal trial of ARD-101 in Prader-Willi syndrome, following submission of the changes to the Food and Drug Administration. The amendment lowers the minimum age for participation from 10 to 7 years, expanding eligibility to younger children with hyperphagia linked to this rare genetic disorder.

The protocol change is intended to reduce barriers to enrollment and better capture ARD-101’s effect across a broader Prader-Willi population, while management reported that HERO enrollment is progressing on schedule toward topline data expected in the third quarter of 2026. The Phase 3 HERO trial plans to recruit 90 patients across multiple countries, with primary and secondary endpoints focused on standardized hyperphagia and clinical impression measures, offering stakeholders a clearer view of ARD-101’s potential role as a differentiated treatment option for this high-burden condition.

The most recent analyst rating on (AARD) stock is a Buy with a $40.00 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 Neutral.

The score is held back primarily by weak financial performance (pre-revenue, widening losses, and substantial cash burn implying funding risk). Offsetting factors include favorable technical momentum (price above major moving averages with positive MACD) and positive corporate pipeline milestones (Phase 3 HERO trial progress and updated program communications), while valuation remains constrained by ongoing losses and a negative P/E.

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 developing novel small-molecule therapeutics that suppress hunger for the treatment of Prader-Willi syndrome and other metabolic diseases. Its lead oral compound, ARD-101, is in Phase 3 development for hyperphagia in Prader-Willi patients, while ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, is being advanced through Phase 2 trials targeting limitations of existing GLP-1 therapies.

The company focuses on activating innate homeostatic pathways and hunger-specific neural signaling, positioning its pipeline as potentially complementary to anti-appetite drugs in obesity and related indications. ARD-101 has received both Orphan Drug and Rare Pediatric Disease designations for Prader-Willi syndrome, underscoring Aardvark’s concentration on rare, hunger-driven disorders and regulatory pathways that can support development and potential market access.

Average Trading Volume: 200,766

Technical Sentiment Signal: Strong Buy

Current Market Cap: $275.4M

For an in-depth examination of AARD stock, go to TipRanks’ Overview page.