ALUMIS INC. 8K

Alumis Inc. announced that its Phase 2b LUMUS trial of envudeucitinib in SLE failed overall endpoints but showed strong efficacy in IFNGS-high patients, with favorable safety and plans to advance to Phase 3 focused on this biomarker-defined subgroup.

On September 1, 2026, Alumis Inc. reported topline Phase 2b LUMUS trial results for its investigational TYK2 inhibitor envudeucitinib in moderate-to-severe systemic lupus erythematosus, disclosing that the study did not meet its primary and secondary endpoints in the overall population due largely to a higher-than-expected proportion of interferon gene signature-low (IFNGS-low) patients and a high placebo response, but showed robust efficacy across primary and key secondary measures in a prespecified interferon gene signature-high (IFNGS-high) subgroup that represents the majority of moderate-to-severe SLE patients; the company also reported generally favorable safety with no new safety signals, confirmed pharmacodynamic target engagement, and outlined plans for End-of-Phase 2 meetings with the FDA and EMA to refine Phase 3 trial design (including IFNGS-based enrollment criteria and dose selection) and continue partnering discussions.

Filing Facts

CIK

1847367

Ticker

ALMS

Form

8K

Source Type

fda

Accession

0001104659-26-104145

Alert Tier

7