---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-114509"
form_type: "8-K"
ticker: "INVA"
cik: "0001080014"
company_name: "Innoviva, Inc."
filed_at: "2023-11-06T23:59:59+00:00"
generated_at: "2026-06-08T18:59:57.363060+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Innoviva's zoliflodacin meets primary endpoint in Phase 3 gonorrhea trial

## Summary
- Zoliflodacin met primary efficacy endpoint with non-inferiority to ceftriaxone+azithromycin in urogenital gonorrhea (point estimate 5.3% difference, 95% CI 1.4%-8.7%).
- Microbiological cure rates >90% in both arms; 90.9% for zoliflodacin vs 96.8% for comparator in Micro-ITT population.
- Secondary analyses at rectal and pharyngeal sites showed comparable cure rates but were not powered for statistical significance.
- Safety profile favorable: no serious AEs, discontinuations, or deaths; headache (9.9%) most common TEAE for zoliflodacin.
- Global Phase 3 trial enrolled 927 patients across 16 sites in US, South Africa, Belgium, Netherlands, and Thailand.

## SEC filing metadata
- accession: 0001104659-23-114509
- form_type: 8-K
- ticker: INVA
- cik: 0001080014
- company_name: Innoviva, Inc.
- filed_at: 2023-11-06T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1080014/000110465923114509/0001104659-23-114509-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1080014/000110465923114509/tm2327472d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-114509
- JSON: https://secwatch.observer/filing/0001104659-23-114509.json
- Plain text: https://secwatch.observer/filing/0001104659-23-114509.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.