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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.
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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.”
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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.
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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.
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The stock has lost nearly 65% of its value so far this year.
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