other material
confidence high
sentiment positive
materiality 0.80
Alumis Phase 3 envudeucitinib hits PASI 90/100 endpoints in plaque psoriasis
ALUMIS INC.
- PASI 90 at Week 24: 68.0% (ONWARD1) and 62.1% (ONWARD2); PASI 100: 41.0% and 39.5%.
- Early onset: PASI 90 separation vs placebo by Week 4; itch relief by Week 2; scalp clearance in ~30% by Week 4.
- Safety profile consistent with Phase 2; no new signals, mainly mild AEs (headache, nasopharyngitis, URTI, acne).
- Company to submit NDA to FDA in H2 2026; Phase 3 long-term extension (ONWARD3) ongoing.
- Also evaluating envudeucitinib in SLE LUMUS Phase 2b with topline data expected Q3 2026.