envudeucitinib (ESK-001) - (ONWARD3)

October 9, 2026: Alumis (NASDAQ: ALMS) reported new Phase 3 ONWARD psoriasis data for envudeucitinib at the 26th Annual Fall Clinical Dermatology Conference and said it remains on track to submit an NDA in 4Q 2026 for moderate-to-severe plaque psoriasis.

Across ONWARD1, ONWARD2, and the long-term extension ONWARD3, the oral TYK2 inhibitor showed durable efficacy and tolerability. In ONWARD3, 54% achieved PASI 100 at Week 48. More than 80% maintained clear or almost clear scalp skin (ss-PGA 0/1) at Week 48, nearly 80% sustained clinically meaningful itch reduction through Week 48, and more than 70% maintained DLQI 0/1 at Week 48.

In ONWARD1/2, about one-third of patients, including those with moderate-to-severe scalp disease, achieved at least a 4-point itch-NRS improvement by Week 2. By Week 16, about 40% reached complete itch resolution (NRS 0) and about 60% reported minimal or no itch (NRS 0/1). About 50% achieved DLQI 0/1 by Week 12.

Patients who crossed over from placebo or apremilast showed rapid improvement and were comparable to continuously treated patients by Week 48. Treatment was generally well tolerated, with no new long-term safety signals reported in ONWARD3.