Alumis Phase 3 oral psoriasis drug envudeucitinib meets all endpoints; NDA planned H2 2026

ALUMIS INC.

Both ONWARD1 and ONWARD2 trials met co-primary endpoints PASI 75 and sPGA 0/1 at Week 16 (p<0.0001).
At Week 24, ~65% achieved PASI 90 and >40% PASI 100, on average across trials.
Safety profile consistent with Phase 2; most common TEAEs were headaches, nasopharyngitis, URIs, and acne.
Envudeucitinib also superior vs apremilast on PASI endpoints at Week 24 (p<0.0001).
Alumis to submit NDA to FDA in H2 2026; topline from SLE Phase 2b expected Q3 2026.

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