Phase 3 psoriasis data cleared; NDA filing imminent — but lupus miss splits the franchise and the runway ends before approval

Alumis is a clinical-stage company developing a targeted immunology drug for psoriasis that is not yet approved, though an application for regulatory review is imminent based on successful Phase 3 trial results.

Alumis built its TYK2 inhibitor franchise on envudeucitinib, targeting psoriasis and lupus; Phase 3 ONWARD data met all endpoints with 54% complete skin clearance at 48 weeks, the highest reported for an oral therapy. The NDA filing rests on that psoriasis package alone, since the LUMUS trial missed its primary endpoint in the overall lupus population, leaving only a subgroup signal. Cash of $502M funds operations to Q4 2027, covering NDA submission but not a full approval cycle, creating financing pressure if the review extends.