Aardvark Therapeutics Inc. (NASDAQ:AARD) said the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application for ARD-101, following the company's previously disclosed voluntary program pause.
ARD-101 is an oral small-molecule therapy designed to stimulate gut-peptide hormone release by activating bitter taste receptors.
The drug was being studied as a potential treatment for hyperphagia, or insatiable hunger, in Prader-Willi Syndrome, a rare genetic disorder that causes physical, cognitive, and behavioral challenges.
FDA Places Full Clinical Hold On Aardvark's ARD-101 Program
The hold applies to all ongoing studies under the IND, including the Phase 3 HERO trial evaluating ARD-101 in patients with hyperphagia linked to Prader-Willi Syndrome, as well as the open-label extension study.
The clinical-stage biotechnology company said it remains in discussions with the FDA as it works toward resolving the hold and identifying a path forward for the therapy candidate.
In March, Aardvark Therapeutics voluntarily paused its Phase 3 HERO trial for Prader-Willi Syndrome. The decision comes as the company is conducting a comprehensive review of safety data.
Observed Side Effects
The company on Friday revealed that it will not announce topline data from the HERO trial as previously anticipated in the third quarter of 2026. This pause was prompted by reversible cardiac observations at higher than target therapeutic doses found during routine safety monitoring in a healthy volunteer study.
Company Plans To Review Unblinded Trial Data
Alongside its discussions with the FDA, Aardvark plans to unblind data collected so far from both the HERO study and the extension trial. The company said the review is intended to assess the overall efficacy and safety profile of ARD-101 and help determine the next steps for the program.
As of February 27, 2026, the company has enrolled 68 patients in the randomized HERO trial and 19 patients in the open-label extension study.
Cash Position Extends Into 2027
Aardvark reported cash, cash equivalents, and short-term investments totaling $91.2 million as of March 31, 2026. The company said it expects existing capital to support operations into mid-2027.
William Blair wrote on Friday that data unblinding could provide a path forward by enabling earlier detection of efficacy signals, thereby better positioning Aardvark to design and conduct the second registration-enabling study.
Analyst Andy Hsieh wrote, “Overall, although we acknowledge the risks associated with Aardvark's current programs in both Prader-Willi Syndrome (PWS) and obesity, we believe the risk/reward opportunity at the current trading value highlights an intriguing investment opportunity.”
William Blair reiterates an Outperform rating on Aardvark.
Price Action
Aardvark Therapeutics shares were down 24.8% at $5.06 at last check on Friday, according to Benzinga Pro.
Over the past month, AARD has gained about 3.3% versus a 7.6% rise in the S&P 500 and is down roughly 64% year-to-date compared to the index’s 9.1% gain.
Photo by Tada Images via Shutterstock
Login to comment