Aardvark Therapeutics: FDA places clinical hold on lead ARD-101 program; Move to Underperform

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Aardvark Therapeutics: FDA places clinical hold on lead ARD-101 program; Move to Underperform

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Aardvark Therapeutics

FDA places clinical hold on lead ARD-101

program; Move to Underperform

Rating Change: UNDERPERFORM | PO: 4.00 USD | Price: 4.75 USD

Clarity needed on clinical hold resolution timelines 15 May 2026

We move our rating on AARD shares to Underperform (from Buy) with new $4 PO as we Equity

look for clarity on next steps following the FDA’s issuance of a clinical hold on the IND

for lead program, ARD-101. Recall, AARD had voluntarily paused all clinical studies

Key Changesrelated to ARD-101 following reversible cardiac observations at high doses (800 mg BID

and 1,600 mg BID) in a healthy volunteer study (see our 3/2 note). We spoke with (US$) Previous Current

management who commented they are in active discussions with FDA to resolve the Inv. Opinion C-1-9 C-3-9

clinical hold. As a first step, AARD guides to fully unblinding the phase 3 HERO and open Inv. Rating BUY UNDERPERFORM

label extension studies in Prader-Willi syndrome (PWS) to help inform a potential path Price Obj. 18.00 4.00

forward. Management guides to sharing with the Street once available but no exact 2028E Rev (m) 78.3 0

timing was provided. While AARD expressed confidence in a potential resolution by year- 2026E EPS -3.59 -3.42

end and we appreciate the transparency, we think the lack of clarity on timing and next 2027E EPS -3.26 -2.56

steps puts future clinical development at risk especially with recent leadership changes 2028E EPS -1.75 -2.82

within the FDA. We also highlight that the competitive landscape continues to evolve

with the progressing launch of Soleno’s Vykat XR (acquired by NBIX) and upcoming data Tazeen Ahmad Research Analyst