Shares of Alumis Inc. (NASDAQ: ALMS) experienced significant upward momentum in Tuesday’s trading session, witnessing a more than fourfold increase in volume compared to their average daily trading figures. The heightened market activity comes on the heels of the company publicizing key data from its Phase 3 clinical trials evaluating envudeucitinib, a novel therapeutic agent targeting moderate-to-severe plaque psoriasis.
Plaid psoriasis, characterized by widespread, thickened, red, and inflamed skin lesions topped by silvery scales due to accelerated keratinocyte proliferation, constitutes the most prevalent manifestation of this chronic autoimmune disorder. Management of this condition remains a critical focus for therapeutic innovation.
Alumis released topline results from the ONWARD1 and ONWARD2 Phase 3 studies, which investigated the efficacy and safety profile of envudeucitinib. Importantly, the drug met all stipulated primary and secondary endpoints with substantial statistical significance in both trials, reinforcing its potential clinical utility.
Key efficacy metrics relied on two co-primary endpoints assessed at Week 16: the Psoriasis Area and Severity Index 75 (PASI 75), reflecting a 75% improvement in the severity and extent of psoriasis, and the static Physician’s Global Assessment (sPGA) scores of 0 or 1, indicating clear or almost clear skin. Envudeucitinib demonstrated notably superior skin clearance relative to placebo across these domains.
Aggregate data from ONWARD1 and ONWARD2 indicated that 74% of participants achieved PASI 75, while 59% attained sPGA 0/1, with evidence suggesting durability and intensification of response over time. Furthermore, placebo-adjusted response rates remained consistent across both studies, reinforcing the reliability of these findings.
Extending the evaluation period to Week 24, patients treated with envudeucitinib exhibited robust improvements on more stringent skin clearance measures: approximately 65% realized PASI 90, and over 40% reached complete skin clearance, reflected by PASI 100 scores. Notably, early efficacy signals emerged rapidly, with separation from placebo observed as soon as Week 4 for PASI 90 levels.
Beyond objective clinical measures, the trials also recorded meaningful improvements in patient-reported outcomes, including reductions in itchiness and enhancements in quality of life, which enrich the overall therapeutic narrative.
In direct comparisons within each trial, envudeucitinib outperformed Amgen Inc.’s (NASDAQ: AMGN) Otezla (apremilast) in all PASI endpoints at Week 24, highlighting its competitive efficacy profile.
Regarding safety, envudeucitinib administration was generally well tolerated through the 24-week evaluation period, with adverse event profiles consistent with those previously observed in Alumis’ Phase 2 clinical program.
Looking ahead, Alumis intends to disseminate more comprehensive data from the ONWARD studies at an upcoming medical congress. The company also has plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) during the latter half of 2026, marking a critical regulatory milestone.
Additionally, Alumis is advancing its investigational pipeline with the LUMUS Phase 2b study of envudeucitinib in systemic lupus erythematosus (SLE), with topline results anticipated in the third quarter of 2026.
Market response was immediate and pronounced; at the time of reporting, Alumis shares surged 115.58% to $17.91, establishing a fresh 52-week intraday high per Benzinga Pro data, underscoring investor optimism surrounding the trial outcomes and forthcoming regulatory activities.