secwatch.observer — SEC 8-K summary
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Issuer:     Innoviva, Inc. (INVA)
CIK:        0001080014
Form:       8-K
Filed at:   2023-11-06T23:59:59+00:00
Accession:  0001104659-23-114509
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1080014/000110465923114509/0001104659-23-114509-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1080014/000110465923114509/tm2327472d2_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-114509

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer