Innoviva, Inc.’s (INVA) Zoliflodacin, an investigational, first-in-class, single oral dose, spiropyrimidinetrione antibiotic for the treatment of uncomplicated gonorrhea, is under priority review by the FDA, with a decision expected on December 15, 2025.Zoliflodacin is specifically intended for adults and pediatric patients 12 years and older and is being developed in partnership with The Global Antibiotic Research & Development Partnership ("GARDP").Gonorrhoea is the world’s second most common bacterial sexually transmitted infection, affecting both men and women. If left untreated, it can lead to severe and lasting health complications. Globally, more than 82 million new infections occur each year.If approved, Zoliflodacin would be the first new antibiotic for treating gonorrhoea in decades.INVA closed Wednesday’s (November 26, 2025) trading at $21.71, down 0.05%.