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Aardvark Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Updates

AARD
  • FDA lifted the clinical hold on ARD-101 for treating hyperphagia in Prader-Willi Syndrome (PWS) in October 2026.
  • Aardvark conducted required ECG and in vitro cardiac sodium channel studies showing no QRS or QT interval prolongation at 200 mg or 400 mg twice daily doses.
  • The FDA approved an open-label trial design for ARD-101 at 200 mg twice daily in PWS patients.
  • A meeting with the FDA is scheduled for the first quarter of 2027 to discuss the proposed clinical development plan.
  • The company expects to resume PWS clinical activities in 2027, subject to FDA alignment.
  • Exploratory data from the terminated HERO trial showed numerically greater HQ-CT score reductions with ARD-101 compared to placebo.
  • The HERO trial was randomized for 67 of the planned 90 participants before early termination, limiting efficacy interpretation.
  • In the open-label extension (OLE) trial, participants switching to ARD-101 saw an average additional 6-point HQ-CT reduction after four weeks.
  • ARD-101 demonstrated a generally well-tolerated safety profile, with most adverse events being mild to moderate.
  • One serious cardiac event occurred in the HERO trial at 800 mg BID, attributed by the FDA to a drug-drug interaction with pitolisant.
  • Aardvark believes CYP2D6-mediated interaction risks can be managed through medication restrictions or dose adjustments.
  • David Zhang, Ph.D., MBA, was appointed to the Board of Directors in October 2026.
  • Cash, cash equivalents, and short-term investments totaled $60.3 million as of September 30, 2026, sufficient to fund operations through 2027.
  • Research and development expenses were $15.7 million for the third quarter of 2026, driven by cardiac safety study costs.
  • General and administrative expenses were $4.0 million for the third quarter of 2026.
  • The company reported a net loss of $19.2 million for the third quarter of 2026.
Company
Aardvark Therapeutics, Inc.
Keywords
Nasdaq:AARD, Aardvark Therapeutics, Inc.