Critical care and infectious disease specialist Innoviva Specialty Therapeutics Inc (IST), a subsidiary of Innoviva Inc (Nasdaq:INVA), announced on Thursday that the US Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application of zoliflodacin, a first-in-class oral antibiotic for uncomplicated gonorrhea.

The FDA has assigned a target action date of 15 December 2025 under the Prescription Drug User Fee Act, and is expected to inform Innoviva of a potential Advisory Committee Meeting in the Day 74 letter.

If approved, zoliflodacin would be the first new antibiotic in decades for treating gonorrhea, which has become increasingly resistant to current therapies.

Zoliflodacin has been granted Qualified Infectious Disease Product designation, which provides eligibility for Priority Review and extended market exclusivity.

Entasis Therapeutics Inc, an affiliate of Innoviva Specialty Therapeutics, holds commercial rights for zoliflodacin in North America, Europe, and Asia-Pacific. The Global Antibiotic Research & Development Partnership retains rights in over three-quarters of global markets, including low- and middle-income countries. GARDP plans to work with health authorities to ensure access to zoliflodacin where approved, while promoting appropriate and sustainable use.

Gonorrhea causes over 82 million infections annually and has become increasingly drug-resistant, prompting urgent global health concerns.