09:04 AM EDT, 06/12/2025 (MT Newswires) -- Innoviva ( INVA ) said Thursday that the US Food and Drug Administration granted priority review to a new drug application for experimental oral antibiotic zoliflodacin for the treatment of uncomplicated gonorrhea in adults and adolescents aged 12 and up.

If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades, Innoviva ( INVA ) said.

The FDA is set to decide on the approval of the drug by Dec. 15, the company said, adding that the health agency is expected to decide on convening an advisory committee meeting in its upcoming Day 74 letter.

Shares of the company were up 1.8% in recent Thursday premarket activity.