FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025

WALTHAM, Mass. & GENEVA--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in