AARD Stock Plummets After Hours As Cardiac Safety Concerns Trigger FDA Hold On Late-stage Program

• The hold follows the company’s earlier voluntary pause in late February 2026, triggered by reversible cardiac observations seen at supratherapeutic doses in a healthy volunteer study.
• Aardvark now plans to unblind the clinical data accumulated to date for ARD-101 to assess the full efficacy and safety profile.
• The company also said that it will continue to engage with the FDA on the path forward for its lead candidate.

Aardvark Therapeutics (AARD) shares tumbled 17% in after-hours trading on Thursday, after the company disclosed that the U.S. Food and Drug Administration has placed a full clinical hold on its lead candidate ARD-101.

Aardvark Therapeutics said the FDA’s full clinical hold applies to the ongoing late-stage HERO trial for hyperphagia in Prader-Willi Syndrome patients and the associated open-label extension (OLE) study. The hold follows the company’s earlier voluntary pause in late February 2026, triggered by reversible cardiac observations seen at supratherapeutic doses in a healthy volunteer study.

AARD’s Next Steps

“We are continuing to work collaboratively with the agency to comprehensively evaluate the data and determine the best path forward for ARD-101,” said CEO Tien Lee while reiterating commitment to patient safety.

In parallel with FDA discussions, Aardvark plans to unblind the clinical data accumulated to date for ARD-101 to assess the full efficacy and safety profile and inform next steps. As of late February, 87 patients have been dosed in the two trials, the company said.

ARD-101 is an oral small-molecule aimed at addressing hyperphagia—the insatiable hunger characteristic of PWS, a rare genetic disorder. This latest development adds to the uncertainty around the ARD-101 program, which had already seen its late-stage topline results delayed. The company was previously expecting to release topline data in the third quarter of 2026, but scrapped that timeline after the voluntary pause imposed in February. No fresh timeline has been issued so far.

The company reported a solid cash position of $91.2 million as of March 31, 2026, which it believes is sufficient to fund operations into mid-2027.

How Did AARD Retail Traders React?

On Stocktwits, retail sentiment around AARD stock stayed within the ‘neutral’ territory while message volume remained at ‘high’ levels.

According to data from Koyfin, eight of the 12 analysts covering AARD rate it ‘Buy’ while four rate it ‘Hold.’ The 12-month average price target on the stock is $16.70, representing a potential upside of about 148%.

Earlier this week, Bank of America lowered its price target on AARD to $18 from $20 while retaining its ‘Buy’ rating on the stock after the firm released its first quarter report, wherein it said that it will provide further guidance on its ARD-101 and ARD-201 programs in the second quarter. The company placed a voluntary pause on ARD-201 in March, as it is a fixed-dose combination of ARD-101 with a dipeptidyl peptidase-4 (DPP-4) inhibitor being studied for weight loss and weight regain prevention.

AARD stock has fallen 23% over the past 12 months. 

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