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Updated: 14-May-26 16:05 ET
AARD:  Aardvark Therapeutics announces the U.S. Food and Drug Administration has placed a full clinical hold on its investigational new drug application for ARD-101 related to the Company’s previously announced voluntary pause  (6.73 +0.14)
  • The clinical hold applies to all ongoing clinical studies under the IND, including the Phase 3 HERO trial evaluating ARD-101 for the treatment of hyperphagia in patients with Prader-Willi Syndrome and the Phase 3 open-label extension trial.
    • The Company remains in active discussions with the FDA to support resolution of the clinical hold and determine a path forward for the ARD-101 program.
  • In parallel with its ongoing engagement with the FDA, Aardvark intends to unblind the clinical data accumulated to date across both the HERO trial and the OLE trial to assess the totality of available efficacy and safety data and to support an informed determination of next steps for the ARD-101 program.
  • The Company believes it can fund projected operations into mid-2027.
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