secwatch.observer — SEC 8-K summary
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Issuer:     Zenas BioPharma, Inc. (ZBIO)
CIK:        0001953926
Form:       8-K
Filed at:   2026-01-05T23:59:59+00:00
Accession:  0001104659-26-000402
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 2.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Zenas BioPharma reports positive Phase 3 INDIGO trial of obexelimab in IgG4-RD; plans BLA in Q2 2026
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- Obexelimab met primary endpoint: 56% reduction in IgG4-RD flare risk vs placebo (HR 0.443, p=0.0005).
- All four key secondary endpoints met with high statistical significance (p≤0.0049).
- Safety profile favorable: SAEs 10% obexelimab vs 19% placebo; fewer infections.
- Preliminary cash $360.5M as of Dec 31, 2025; expected to fund operations through end of 2026.
- BLA submission to FDA planned Q2 2026; MAA to EMA H2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1953926/000110465926000402/0001104659-26-000402-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1953926/000110465926000402/tm261774d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-000402

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