Alumis reports Phase 3 envudeucitinib data showing high skin‑clearance and itch relief, NDA slated for Q4 2026
Alumis Inc. presented results from its three Phase 3 ONWARD trials of the oral TYK2 inhibitor envudeucitinib in moderate‑to‑severe plaque psoriasis. At week 48, 54% of patients achieved a PASI 100 response, and the majority maintained clear or nearly clear scalp skin. Itch severity fell markedly, with about 40% reporting complete resolution by week 16 and roughly 80% sustaining meaningful itch reduction through week 48. The company said the data support a New Drug Application filing in the fourth quarter of 2026.
Why it matters
The company’s filing timeline signals a potential new oral therapy entering a market dominated by Bristol‑Myers Squibb’s Sotyktu, which generated $291 million in 2023 sales. If approved, envudeucitinib could capture market share from existing oral TYK2 inhibitors.
Key facts
- 154% of patients reached a PASI 100 response at week 48. globenewswire.com
- 2Over 80% of participants in the long‑term extension maintained clear or almost clear scalp disease at week 48. rttnews.com
- 3Approximately 40% of patients achieved complete itch resolution by week 16, and about 80% sustained clinically meaningful itch reduction through week 48. rttnews.com
- 4Around 50% of patients in the earlier trials had a DLQI score of 0‑1 by week 12; more than 70% maintained that score at week 48 in the extension. rttnews.com
- 5Alumis plans to submit an NDA for envudeucitinib in the fourth quarter of 2026. globenewswire.com
- 6Shares rose 3.49% in pre‑market trading to $7.21 after the announcement. rttnews.com
Summary written by AlphAI AI Desk from 6 of 6 sources. Not investment advice. Figures are as stated by the linked sources.