Aardvark Therapeutics (AARD) ARD-101 Safety Concealment Case
$AARD investors filed a claim against Aardvark Therapeutics, Inc. for overstating the safety of its lead drug candidate ARD-101, which the company touted as "well-tolerated" and safe from serious side effects due to being "99% gut-restricted."
Aardvark voluntarily paused its pivotal Phase 3 trial after finding reversible cardiac issues, sending shares down 56.2%; months later, the FDA placed a full clinical hold on the drug, sending shares down another 32.1%.
$AARD investors can join this case to be notified about potential recovery.
Case Details:
Aardvark Therapeutics is a clinical-stage biopharmaceutical company developing small-molecule therapies to treat hyperphagia, or extreme insatiable hunger, in patients with Prader-Willi Syndrome. Its lead product candidate, ARD-101, was described by the company as a "gut-restricted" drug with minimal systemic exposure, which management said reduced the risk of toxicity and had contributed to the drug being "well-tolerated" in trials.
Aardvark went public in February 2025, raising roughly $87.6 million at $16.00 per share, with its IPO documents and subsequent SEC filings repeating these safety and tolerability claims while touting a "potentially pivotal" Phase 3 trial (the HERO trial) with topline data expected in early 2026.
Throughout the Class Period, executives including CEO Tien-Li Lee and then-COO Bryan Jones repeatedly reassured investors of ARD-101's "very, very clean" safety profile, emphasizing that its restriction to the gut diminished concerns about cardiac and other systemic toxicity.
On February 27, 2026, Aardvark disclosed it was voluntarily pausing the HERO trial after "reversible cardiac observations at above target therapeutic doses" emerged during a routine safety study, also disclosing it no longer expected topline data on its prior timeline.
On this news, shares fell $7.02, or 56.2%, to close at $5.47 on March 2, 2026. Despite this, the company continued to reassure investors that ARD-101 retained its therapeutic potential and would receive an update by the second quarter of 2026. Then, on May 14, 2026, Aardvark disclosed that the FDA had placed a full clinical hold on its investigational new drug application for ARD-101, halting all ongoing studies including the HERO trial.
On this news, shares fell $2.16, or 32.1%, to close at $4.57 on May 15, 2026, well below the $16.00 IPO price.
Based on these events, $AARD investors filed a claim against Aardvark, alleging the company:
Overstated ARD-101's safety profile, concealing that the drug was less safe than represented in the IPO offering documents and subsequent public statements
Misrepresented that ARD-101's clinical, regulatory, and commercial prospects were on track, despite undisclosed cardiac safety risks
Failed to disclose material facts necessary to make its statements about ARD-101's tolerability and trial progress not misleading
Investors argue Aardvark misled the market about the true safety profile of its lead drug candidate, causing losses when the trial pause and subsequent FDA clinical hold revealed the concealed risks.