EL7.AI
StocksMedium•22 October 2026•
3 min read

FDA lifts clinical hold on Aardvark's ARD-101 for Prader-Willi syndrome

Key Facts

1Research and development expenses totaled $10.5 million in the second quarter of 2026, compared with $13.1 million in the corresponding period of 2025.
2The company estimated in its August update that its cash resources were sufficient to fund anticipated operations into late 2027.
3Aardvark confirmed that the U.S. Food and Drug Administration had lifted the clinical hold on its experimental treatment for Prader-Willi syndrome.
4The company terminated its randomized controlled trial and open-label extension trial in June 2026.
5The company scheduled an update call for October 23, 2026, at 8:00 a.m. Eastern Daylight Time.

Aardvark Therapeutics said the U.S. Food and Drug Administration had lifted the clinical hold on ARD-101 for the treatment of Prader-Willi syndrome, according to an announcement on its investor relations website. The regulatory development follows the company's termination of its randomized controlled trial and open-label extension trial in June 2026, according to its second-quarter financial results update. The company said in August that it did not intend to resume either trial under its previous design, separating the lifting of the hold from the restart of those same studies. The drug is an oral small-molecule treatment, according to the company's description of its development program. It was designed to stimulate the release of gut hormones by activating bitter taste receptors, the mechanism targeted by the experimental treatment.

The voluntary pause stemmed from cardiac observations the company identified during routine safety monitoring in a study of healthy volunteers. Aardvark described them in its statement as "reversible cardiac observations at doses above the targeted therapeutic doses." As of February 27, 2026, the treatment had been administered to 68 patients in the randomized controlled trial, according to the company's statement on plans to review its data. Another 19 patients had received the treatment in the open-label extension trial as of the same date. The company announced on May 14, 2026, that the FDA had imposed a full clinical hold, according to its filing with the U.S. Securities and Exchange Commission. In an earlier reaction to the hold, Morgan Stanley downgraded the company's shares to "Underweight" from "Equal-weight," according to Investing.com. The bank also cut its price target to $3.00 from $7.00 as part of its earlier review linked to the regulatory hold.

On the financial front, Aardvark's results showed research and development expenses of about $10.5 million in the second quarter of 2026. That compared with $13.1 million in the corresponding quarter of 2025, according to the company's financial results statement. The quarter covered by those expenses included the termination of the two trials in June, while the company's estimate of its funding runway was issued in its August update. Aardvark said at the time that its existing cash resources were sufficient to fund anticipated operations into late 2027. Following the announcement that the hold had been lifted, the company scheduled a call to provide an update on the drug for October 23, 2026, according to the event page on its investor relations website. The call is scheduled to begin at 8:00 a.m. Eastern Daylight Time.