Alumis (NASDAQ:ALMS) surged as much as 82% in early trading Tuesday after its experimental oral drug, envudeucitinib, outperformed both a placebo and Amgen’s blockbuster Otezla in two Phase 3 trials for moderate-to-severe plaque psoriasis.
The results position the South San Francisco-based biotech to challenge established oral therapies and injectables in an $11 billion market by offering "biologic-like" skin clearance in a twice-daily pill.
The parallel ONWARD1 and ONWARD2 studies, which enrolled over 1,700 patients, showed that approximately 65% of those taking envudeucitinib achieved a 90% reduction in skin symptoms (PASI 90) by Week 24.
Notably, more than 40% of patients reached complete skin clearance (PASI 100).
The drug also demonstrated a rapid onset of action, with statistically significant separation from the placebo group as early as four weeks into the trial.
Safety remained a key highlight for investors; envudeucitinib maintained a profile consistent with previous mid-stage studies, with no new safety signals identified through 24 weeks.
The most common adverse events included headache, acne, and upper respiratory tract infections.
Alumis plans to submit its New Drug Application (NDA) to the FDA in the second half of 2026, aiming to join Bristol Myers Squibb’s Sotyktu as a leading next-generation TYK2 inhibitor.