Aardvark Therapeutics Faces Investor Scrutiny After 56% Stock Plunge on Clinical Pause

Hagens Berman law firm opens investigation into whether company misled investors about drug candidate's safety and efficacy

Apr. 9, 2026 at 11:43pm by Ben Kaplan

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A photorealistic studio still life featuring a single, polished metal syringe floating on a clean white background, conceptually representing the regulatory and safety challenges facing a pharmaceutical drug candidate.A pharmaceutical syringe suspended in a sterile studio setting symbolizes the high-stakes clinical development process facing Aardvark Therapeutics' lead drug candidate.San Francisco Today

Investors in Aardvark Therapeutics (NASDAQ: AARD) saw the price of their shares plummet 56% on March 2, 2026 after the company announced it was pausing a Phase 3 clinical trial for its lead drug candidate ARD-101 due to 'reversible cardiac observations.' The severe market reaction has prompted national shareholder rights firm Hagens Berman to open an investigation into whether Aardvark may have misled investors about ARD-101's development, safety, and efficacy, as well as the company's communications with the FDA.

Why it matters

Aardvark had previously touted ARD-101 as a 'first-in-class' drug for treating hyperphagia (insatiable hunger) in patients with Prader-Willi Syndrome, and had assured investors the drug had a 'very tolerable safety profile.' The sudden clinical pause and emergence of cardiac safety signals have raised questions about the company's transparency and disclosures to investors.

The details

In the past, Aardvark emphasized that ARD-101 represented a 'first-in-class' drug and that, 'through alignment with the FDA,' it started HERO patients 13 years and older, moved to dosing patients 10 years and older, and intended to dose patients as young as 4 years old. The company also assured investors that ARD-101 has 'a very tolerable safety profile.' However, on March 2, 2026, Aardvark abruptly announced it was pausing the HERO trial due to a serious safety risk - 'reversible cardiac observations.' The company also said it no longer anticipates announcing topline data from the HERO trial during the third quarter of 2026.

  • On March 2, 2026, Aardvark Therapeutics announced it was pausing its Phase 3 HERO trial for ARD-101.
  • Aardvark said it no longer expects to announce topline data from the HERO trial in Q3 2026.

The players

Aardvark Therapeutics

A biopharmaceutical company developing a drug candidate called ARD-101 to treat hyperphagia in Prader-Willi Syndrome patients.

Hagens Berman

A national shareholder rights law firm that has opened an investigation into whether Aardvark Therapeutics misled investors about ARD-101.

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What they’re saying

“We're focused on whether Aardvark may have misled investors about ARD-101's development, its safety and/or efficacy, and the company's communications with the FDA.”

— Reed Kathrein, Partner, Hagens Berman

What’s next

The judge in the case will decide on whether to allow Aardvark Therapeutics to resume the HERO trial.

The takeaway

This case highlights the importance of biotech companies being transparent about drug development challenges and potential safety issues, especially for high-profile lead candidates. Investors will be closely watching Aardvark's next steps and communications as it navigates this clinical setback.