Alumis Inc. (NASDAQ:ALMS) stock is trading higher on Tuesday, with a session volume of 4.33 million compared to the average volume of 1.02 million as per data from Benzinga Pro.
Alumis on Tuesday released topline results from its Phase 3 ONWARD1 and ONWARD2 clinical trials of envudeucitinib in patients with moderate-to-severe plaque psoriasis.
Plaque psoriasis is the most common form of this chronic autoimmune skin condition, causing thick, red, inflamed patches (plaques) covered with silvery scales due to rapid skin cell buildup.
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Data
Envudeucitinib met all primary and secondary endpoints with high statistical significance in ONWARD1 and ONWARD2.
In each of these trials, envudeucitinib achieved superior skin clearance compared with placebo on the co‑primary endpoints of Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0/1 at Week 16.
On average across both ONWARD1 and ONWARD2, 74% of patients achieved PASI 75 and 59% of patients achieved sPGA 0/1, with responses deepening over time.
In addition, the placebo-adjusted response rates for the co-primary endpoints were consistent between the two trials.
At Week 24, on the higher hurdle skin clearance measures, approximately 65% of patients achieved PASI 90, and more than 40% achieved PASI 100, on average across both trials.
Rapid responses were observed, with clear separation from placebo on PASI 90 as early as Week 4.
In addition, consistent and clinically meaningful improvements across patient-reported outcomes relating to itch and quality of life were observed.
Envudeucitinib also achieved superior skin clearance compared with Amgen Inc.’s (NASDAQ:AMGN) Otezla (apremilast) in each trial on all PASI endpoints at Week 24.
Treatment with envudeucitinib was generally well tolerated through Week 24 in both trials, with a safety profile consistent with Alumis’ Phase 2 program.
Upcoming Catalysts
Alumis plans to present additional results from ONWARD1 and ONWARD2 at an upcoming medical meeting and to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2026.
Topline data from the LUMUS Phase 2b trial of envudeucitinib in systemic lupus erythematosus (SLE) are expected to be announced in the third quarter of 2026.
ALMS Price Action: Alumis shares were up 115.58% at $17.91 at the time of publication on Tuesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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