Alumis Envudeucitinib Phase 2b LUMUS Trial Fails Primary and Secondary Endpoints in Systemic Lupus Erythematosus; Shares Fall Approximately 55%
Alumis (NASDAQ: ALMS) announced Tuesday September 1, 2026 that the Phase 2b LUMUS trial of envudeucitinib (an oral allosteric TYK2 inhibitor designed to correct immune dysregulation across IL-23, IL-17, and Type I interferon pathways) failed to meet the primary endpoint of British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at Week 48 in patients with systemic lupus erythematosus (n=408). All secondary objectives also missed. Strong responses were observed in the pre-specified high-interferon-gene-signature subgroup (which characterizes a majority of moderate-to-severe SLE patients), but IFNGS-high patients were under-represented in the overall trial population which reduced the treatment effect. Alumis (ALMS) shares fell approximately 55% and erased more than $1.6 billion of market capitalization. The company will meet with regulators to discuss a Phase 3 SLE path targeting the IFNGS-high subgroup and remains on track to submit the envudeucitinib NDA for moderate-to-severe plaque psoriasis in Q4 2026 following the Phase 3 ONWARD program win.