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Alumis Psoriasis Pill Meets Phase 3 Goals, Outperforms Otezla

The company aims to file for U.S. approval in the second half of 2026 following two studies that showed rapid, deep responses with tolerability consistent with earlier trials.

Overview

  • Envudeucitinib met all primary and secondary endpoints with high statistical significance in the ONWARD1 and ONWARD2 Phase 3 trials.
  • Across both studies, 74% achieved PASI 75 and 59% reached sPGA 0/1 at Week 16, deepening to about 65% at PASI 90 and over 40% at PASI 100 by Week 24.
  • The oral TYK2 inhibitor showed superiority to placebo on co‑primary endpoints and demonstrated clear separation on PASI 90 as early as Week 4.
  • Safety through Week 24 was generally well tolerated and aligned with the Phase 2 profile.
  • Alumis plans to present additional ONWARD data at a medical meeting and to submit an NDA in H2 2026, as shares jumped to $17.91 for a roughly 116% intraday gain.