Catalyst overview
Research summary
This catalyst tracks a Approved update for NUZOLVENCE® (zoliflodacin) in Uncomplicated Gonorrhoea. The expected timing is based on the latest available company guidance and may change.
6/10/25- US FDA NDA accepted. Granted Qualified Infectious Disease Product (QIDP) designation. PDUFA date of Dec 15, 2025. 10/21/25- Presentation of subset analysis at IDWeek'25. 11/05/25:- IDWeek 2025 subgroup analyses presented. FDA does not plan AdCom; PDUFA date remains December 15, 2025. 12/12/25:- FDA approved NUZOLVENCE (zoliflodacin) for uncomplicated urogenital gonorrhea; U.S. commercialization planned for H2 2026. 05/06/26:- Company remains on track to launch NUZOLVENCE in H2 2026. 08/05/26:- PR No update.
Verification
Confirm timing and program details against the company announcement or filing.