Alumis experimental lupus drug fails primary endpoint in phase 3 trial

Sep 1, 2026

Alumis shares plummeted nearly 55% on September 1, 2026, after its experimental oral drug envudeucitinib failed to meet primary and secondary goals in a 408-patient mid-stage trial for systemic lupus erythematosus. Despite the overall failure, Alumis plans to discuss a Phase 3 trial with regulators, citing robust responses in a subgroup of patients with high interferon activity. The company also remains on track to file for U.S. approval of envudeucitinib in plaque psoriasis in late 2026.

Envudeucitinib lupus trial failure

▪Systemic lupus erythematosus is estimated to affect more than 200,000 people in the United States, according to the Centers for Disease Control and Prevention
▪Alumis' experimental oral drug envudeucitinib failed to meet its primary and secondary objectives in a mid-stage trial of 408 adults with moderate-to-severe systemic lupus erythematosus
▪In the 48-week clinical trial, envudeucitinib missed statistical significance on multiple assessments of disease activity and treatment responses
▪Envudeucitinib was well-tolerated during the clinical trial and was associated with fewer adverse events than a placebo, showing no new safety concerns

High interferon subgroup response

▪The response observed in the high interferon subgroup was similar to results from testing of Bristol Myers Squibb's TYK2 inhibitor Sotyktu
▪Alumis stated that patients with high interferon activity made up a smaller share of the trial population than expected, which contributed to the overall study miss
▪Alumis reported that trial participants with a high interferon gene signature, a marker linked to lupus severity, showed robust improvement on the study's main measure of disease activity

TYK2 inhibitor class challenges

▪Multiple TYK2 inhibitors have struggled in clinical trials for lupus and inflammatory bowel disease, despite showing potency against psoriasis
▪Bristol Myers Squibb's Sotyktu was the first TYK2 inhibitor approved for psoriasis, but its sales have been lower than the company anticipated
▪Envudeucitinib belongs to a class of oral medicines called TYK2 inhibitors, which block a key immune-system protein to calm overactive inflammation
▪Takeda Pharmaceuticals spent $4 billion to acquire a next-generation TYK2 inhibitor from Nimbus Therapeutics

Alumis stock decline

▪Alumis shares fell by nearly 55% on September 1, 2026, following the announcement of the envudeucitinib trial results
▪Wall Street viewed the Alumis trial as a significant test in systemic lupus erythematosus, a disease long considered highly challenging for drug development

Planned Phase 3 discussions

▪Alumis Chief Medical Officer Jörn Drappa stated that envudeucitinib's performance in the high interferon subgroup makes continued development in lupus worth pursuing
▪Alumis plans to meet with regulators to discuss starting a Phase 3 trial of envudeucitinib targeting the subgroup of lupus patients with higher interferon activity

Psoriasis regulatory filing timeline

▪Alumis remains on track to file for U.S. regulatory approval of envudeucitinib for moderate-to-severe plaque psoriasis in the fourth quarter of 2026
▪Alumis Chief Executive Officer Martin Babler stated that the lupus trial results would not cause significant changes to the company's overall development timeline