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Shares of Aardvark Therapeutics (AARD) plummeted more than 34% on Friday, to hit their lowest levels in over a month, following the U.S. Food and Drug Administration’s decision to impose a full clinical hold on the firm’s lead therapy candidate across all ongoing studies targeting hyperphagia in patients with Prader-Willi Syndrome.
The clinical hold follows the company’s voluntary pause of the program in late February 2026, after reversible heart-related findings were observed at very high doses in a healthy volunteer study.
Following the FDA’s decision, Wall Street turned skeptical about the stock, with at least two firms downgrading the stock.
BTIG downgraded Aardvark Therapeutics to ‘Neutral’ from ‘Buy’ but did not provide a price target, according to The Fly.
The firm said the stock’s near-term outlook now depends on several key factors falling into place, including a clearer understanding of the drug’s exposure levels and cardiac safety signals, positive efficacy data from the unblinded HERO study, and the company’s ability to establish a viable regulatory path while operating within its cash runway through mid-2027.
Given those uncertainties and the lack of clear timelines, the firm said it “makes it hard to lean into AARD at this juncture.”
Morgan Stanley downgraded the stock to ‘Underweight’ from ‘Equal Weight’ and cut its price target to $3 from $7, according to The Fly. The firm said that while the unblinded data “could provide insights,” it could take some time, and a path forward for the therapy remains unclear.
B. Riley noted that the company plans to unblind existing trial data in the near term and remains in discussions with regulators, with a potential path forward likely centered on a lower-dose version of the treatment, despite ongoing concerns about the cardiac safety findings. Despite lowering the price target to $7 from $8, the brokerage maintained a ‘Buy’ rating.
On Thursday, Aardvark had mentioned its plans to unblind the clinical data collected so far for ARD-101 to better evaluate the treatment’s safety and effectiveness and determine the next steps for the program.
Despite the intra-day slump, retail sentiment on AARD turned ‘bullish’ from ‘neutral’ a day earlier, while message volumes remained ‘high.’
One user sees an opportunity to pick up the stock at under $3. It is currently trading at $5.
The stock has lost nearly 65% of its value so far this year.
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