secwatch.observer — SEC 8-K summary
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Issuer:     Zenas BioPharma, Inc. (ZBIO)
CIK:        0001953926
Form:       8-K
Filed at:   2025-10-27T23:59:59+00:00
Accession:  0001104659-25-102317
Event type: other_material
Sentiment:  positive
Materiality: 0.78
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Zenas BioPharma announces Phase 2 MoonStone trial of obexelimab meets primary endpoint with 95% lesion reduction
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- Obexelimab showed 95% relative reduction in new GdE T1 lesions vs placebo (p=0.0009) at weeks 8 and 12.
- Adjusted mean new GdE T1 lesions per scan: 0.01 (obexelimab) vs 0.23 (placebo).
- Safety consistent with prior trials; most common were mild injection site reactions.
- Expects 24-week MoonStone data in Q1 2026; Phase 3 INDIGO (IgG4-RD) topline around year-end 2025.
- Orelabrutinib Phase 3 in PPMS ongoing; SPMS Phase 3 to initiate Q1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1953926/000110465925102317/0001104659-25-102317-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1953926/000110465925102317/tm2529508d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-102317

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