secwatch.observer — SEC 8-K summary
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Issuer:     ALUMIS INC. (ALMS)
CIK:        0001847367
Form:       8-K
Filed at:   2026-09-01T12:30:46+00:00
Accession:  0001104659-26-104145
Event type: other_material
Sentiment:  negative
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Alumis LUMUS Phase 2b misses primary endpoint in SLE; IFNGS-high subgroup shows robust responses
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- LUMUS Phase 2b (n=408) did not meet primary endpoint BICLA at Week 48 in overall SLE population.
- Prespecified IFNGS-high subgroup showed robust responses on BICLA, CLASI-50, SRI-4, and LLDAS.
- Dose-dependent target engagement with maximal suppression at 40mg BID; no new safety signals observed.
- Alumis plans regulatory engagement to discuss Phase 3 development for envudeucitinib in SLE.
- NDA submission for envudeucitinib in moderate-to-severe plaque psoriasis remains on track for 4Q 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1847367/000110465926104145/0001104659-26-104145-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1847367/000110465926104145/tm2624540d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-104145

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