8/103 sources · 3 publishersUpdated Oct 9, 08:42 UTC
Alumis reports 54% PASI‑100 response in Phase 3 psoriasis trial and targets Q4 2026 NDA filing
Alumis Inc. presented new Phase 3 data for its oral TYK2 inhibitor envudeucitinib at a dermatology conference. The ONWARD3 extension showed 54% of patients achieved complete skin clearance (PASI 100) at Week 48, with over 80% maintaining clear scalp skin and substantial itch and quality‑of‑life improvements. The company confirmed its plan to submit a New Drug Application in the fourth quarter of 2026. The results were well tolerated with no new safety signals.
Why it matters
The company says the data support filing an NDA in Q4 2026, which could create upside potential for the stock if the FDA grants approval.
Key facts
- 154% of patients achieved PASI 100 at Week 48 in the ONWARD3 trial. globenewswire.com
- 2Over 80% of patients maintained clear or almost clear scalp skin at Week 48. globenewswire.com
- 3Approximately one‑third of patients achieved clinically meaningful itch reduction as early as Week 2, and nearly 80% sustained it through Week 48. globenewswire.com
- 4More than 70% of patients maintained a DLQI score of 0 or 1 at Week 48. globenewswire.com
- 5Alumis plans to submit an NDA for envudeucitinib in moderate‑to‑severe plaque psoriasis in Q4 2026. tradingview.com
- 6The ONWARD program enrolled more than 1,700 patients across ONWARD1, ONWARD2 and the long‑term extension ONWARD3. investing.com
Summary written by AlphAI from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.