Innoviva (INVA) announced that the FDA has granted Priority Review for the New Drug Application for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15 under the PDUFA. It is expected the FDA will notify Innoviva Specialty Therapeutics regarding the FDA’s decision to conduct an Advisory Committee Meeting in the Day 74 letter. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades.
Claim 50% Off TipRanks Premium and Invest with Confidence
- Unlock hedge-fund level data and powerful investing tools designed to help you make smarter, sharper decisions
- Stay ahead of the market with the latest news and analysis so your portfolio is always positioned for maximum potential
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on INVA:
- Innoviva Specialty Therapeutics announces FDA accepts NDA for zoliflodacin
- Innoviva Elects Board Members and Approves Compensation
- Innoviva subsidiary announces U.S. commercial availability of ZEVTERA
- Innoviva’s Strong Q1 2025 Performance and Strategic Progress
- Innoviva reports Q1 EPS (74c) vs. 46c last year