FDA Greenlights Innoviva's NUZOLVENCE, the First Oral Treatment for Gonorrhea
FDA Approval: Innoviva Specialty Therapeutics received FDA approval for NUZOLVENCE (zoliflodacin), a first-in-class oral medication for treating uncomplicated urogenital gonorrhea in patients aged 12 and older.
Clinical Trial Success: The approval was based on the largest Phase 3 clinical trial for a new gonorrhea treatment, conducted in high-prevalence regions across five countries.
Significance of Treatment: NUZOLVENCE is one of the first new treatments for uncomplicated urogenital gonorrhea approved by the FDA in nearly 20 years, addressing a significant public health issue.
Commercialization Plans: Innoviva plans to commercialize NUZOLVENCE in the second half of 2026, either independently or with a partner.
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INVA Stock Fluctuates: 52-Week Low at $16.52
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FDA Greenlights Innoviva's NUZOLVENCE, the First Oral Treatment for Gonorrhea
FDA Approval: Innoviva Specialty Therapeutics received FDA approval for NUZOLVENCE (zoliflodacin), a first-in-class oral medication for treating uncomplicated urogenital gonorrhea in patients aged 12 and older.
Clinical Trial Success: The approval was based on the largest Phase 3 clinical trial for a new gonorrhea treatment, conducted in high-prevalence regions across five countries.
Significance of Treatment: NUZOLVENCE is one of the first new treatments for uncomplicated urogenital gonorrhea approved by the FDA in nearly 20 years, addressing a significant public health issue.
Commercialization Plans: Innoviva plans to commercialize NUZOLVENCE in the second half of 2026, either independently or with a partner.
