Aardvark Therapeutics Inc. (NASDAQ:AARD) shares jumped 25.06% to $4.94 in after-hours trading Thursday after the clinical-stage biopharmaceutical said the Food and Drug Administration lifted the clinical hold on its Prader-Willi Syndrome (PWS) drug candidate.
The company said the agency had lifted the hold on the Investigational New Drug application for ARD-101, an oral treatment being developed for hyperphagia, a condition that causes extreme hunger, in people with Prader-Willi syndrome (PWS), a rare genetic disorder.
FDA Hold Removal Clears Major Regulatory Overhang
A clinical hold is an FDA order that stops human trials until safety questions are resolved. For a clinical-stage company with no approved products, lifting one restores a key path toward potential approval.
Aardvark is scheduled to host a webcast Friday at 8 a.m. ET to discuss data from the terminated HERO and OLE trials, potentially providing investors with additional insight into the future of ARD-101.
CEO Tien Lee said, “We are pleased that the FDA has lifted the clinical hold on ARD-101, allowing us to continue advancing our clinical development program.” He added that the company completed the work needed to resume studies in alignment with the FDA.
Cardiac Safety Data Behind the Reversal
Aardvark voluntarily paused dosing in its Phase 3 HERO trial and open-label extension in February before the trials were subsequently terminated.
The company then ran an additional ECG study and an in vitro cardiac sodium channel (NaV1.5) study. Aardvark said no cardiac events were observed at ARD-101 doses of 200 mg and 400 mg twice daily.
The California-based company said it plans to resume ARD-101 development in PWS patients after further engagement with the FDA on the Phase 3 trial design.
Trading Metrics, Technical Analysis
Aardvark has a market capitalization of about $86.45 million. Over the past 52 weeks, its stock has traded as high as $16.60 and as low as $3.35.
AARD has a Relative Strength Index (RSI) of 37.65.
Over the past 12 months, the small-cap biotech stock has fallen 63.59%.
Price Action: The gain in the late trading session follows a 10.43% drop during the regular session, when AARD closed at $3.95, according to Benzinga Pro data.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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