Core Insights - Alumis Inc. (NASDAQ:ALMS) stock is experiencing a significant increase, trading at a new 52-week high of $17.91, up 115.58% [8] - The company released positive topline results from its Phase 3 ONWARD1 and ONWARD2 clinical trials for envudeucitinib, a treatment for moderate-to-severe plaque psoriasis [1][3] Clinical Trial Results - Envudeucitinib met all primary and secondary endpoints with high statistical significance in both ONWARD1 and ONWARD2 trials [3] - On average, 74% of patients achieved a Psoriasis Area and Severity Index (PASI) 75 response, and 59% achieved a static Physician's Global Assessment (sPGA) 0/1 at Week 16 [4] - At Week 24, approximately 65% of patients achieved PASI 90, and over 40% achieved PASI 100 across both trials [4] - Rapid responses were noted, with significant separation from placebo on PASI 90 as early as Week 4 [5] Comparative Efficacy - Envudeucitinib demonstrated superior skin clearance compared to Amgen Inc.'s Otezla (apremilast) on all PASI endpoints at Week 24 [5] - Consistent and clinically meaningful improvements were observed in patient-reported outcomes related to itch and quality of life [5] Safety Profile - Treatment with envudeucitinib was generally well tolerated through Week 24, with a safety profile consistent with Alumis' Phase 2 program [6] Future Developments - Alumis plans to present additional results from ONWARD1 and ONWARD2 at an upcoming medical meeting and intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2026 [7] - Topline data from the LUMUS Phase 2b trial of envudeucitinib in systemic lupus erythematosus (SLE) is expected in the third quarter of 2026 [7]
Alumis Skin Drug Shows Clear Benefits In Late Trials, Stock Soars