secwatch.observer — SEC 8-K summary
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Issuer:     ALUMIS INC. (ALMS)
CIK:        0001847367
Form:       8-K
Filed at:   2026-01-06T23:59:59+00:00
Accession:  0001104659-26-001073
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Alumis Phase 3 oral psoriasis drug envudeucitinib meets all endpoints; NDA planned H2 2026
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- Both ONWARD1 and ONWARD2 trials met co-primary endpoints PASI 75 and sPGA 0/1 at Week 16 (p<0.0001).
- At Week 24, ~65% achieved PASI 90 and >40% PASI 100, on average across trials.
- Safety profile consistent with Phase 2; most common TEAEs were headaches, nasopharyngitis, URIs, and acne.
- Envudeucitinib also superior vs apremilast on PASI endpoints at Week 24 (p<0.0001).
- Alumis to submit NDA to FDA in H2 2026; topline from SLE Phase 2b expected Q3 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1847367/000110465926001073/0001104659-26-001073-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1847367/000110465926001073/tm262035d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-001073

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