Alumis Inc. (ALMS) delivered the kind of clinical trial results that biotech investors dream about on Tuesday, sending shares soaring more than 115% on volume over four times the normal trading activity. The company announced that its experimental psoriasis drug envudeucitinib crushed all primary and secondary endpoints in two late-stage clinical trials.
The drug is aimed at moderate-to-severe plaque psoriasis, which is exactly what it sounds like and not particularly pleasant. Plaque psoriasis is the most common form of this chronic autoimmune skin condition, causing thick, red, inflamed patches covered with silvery scales as skin cells build up faster than they should.
The Trial Results
Envudeucitinib met all primary and secondary endpoints with high statistical significance in both the ONWARD1 and ONWARD2 Phase 3 trials. The drug achieved superior skin clearance compared to placebo on two key measures: PASI 75 (a 75% improvement in the Psoriasis Area and Severity Index) and sPGA 0/1 (essentially a score indicating clear or nearly clear skin on the static Physician's Global Assessment) at Week 16.
The numbers were strong. On average across both trials, 74% of patients hit the PASI 75 mark and 59% achieved clear or nearly clear skin, with responses continuing to improve over time. The placebo-adjusted response rates were consistent between the two trials, which is what you want to see in a successful development program.
By Week 24, the results got even better. Approximately 65% of patients achieved PASI 90 (90% skin clearance), and more than 40% achieved PASI 100, meaning complete skin clearance. The drug also showed rapid onset, with clear separation from placebo on PASI 90 as early as Week 4. Patients reported consistent and clinically meaningful improvements in itch and quality of life measures.
Head-to-Head Victory
Perhaps most importantly for Alumis's commercial prospects, envudeucitinib beat Amgen Inc.'s (AMGN) Otezla (apremilast), an established psoriasis treatment, on all PASI endpoints at Week 24 in both trials. That's the kind of competitive data that helps convince doctors to prescribe your drug instead of what they're already using.
The safety profile through Week 24 was generally well tolerated in both trials, consistent with what Alumis saw in its Phase 2 program. No major red flags emerged.
What Comes Next
Alumis plans to present more detailed results from ONWARD1 and ONWARD2 at an upcoming medical meeting and intends to submit a New Drug Application to the FDA in the second half of 2026. That timeline puts potential approval somewhere in 2027 if everything goes smoothly.
The company also has another iron in the fire: topline data from the LUMUS Phase 2b trial of envudeucitinib in systemic lupus erythematosus is expected in the third quarter of 2026.
Alumis shares were trading up 115.58% at $17.91 following the announcement, hitting a new 52-week high.