Appili Therapeutics Inc. (TSX: APLI) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and biodefense, today, with its partner Saptalis Pharmaceuticals LLC (“Saptalis”), announced that the Food and Drug Administration (“FDA”) accepted the ATI-1501 New Drug Application (“NDA”). ATI-1501 is Appili’s liquid oral reformulation of the antibiotic metronidazole, which has been licensed to Saptalis. The FDA established a Prescription Drug User Fee (“PDUFA”) action date of September 23, 2023.
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