Alumis Plans FDA Filing for Plaque Psoriasis Drug After Positive Phase 3 Results

By Connor Hart

Alumis plans to seek Food and Drug Administration approval in the later this year for its lead drug candidate after reporting positive late-stage trial results.

The disclosure comes as the biotechnology company on Thursday said it narrowed its loss last year and strengthened its balance sheet with a recent equity raise.

Alumis said its drug, envudeucitinib, met all primary and secondary endpoints in two Phase 3 trials in patients with moderate-to-severe plaque psoriasis. About 65% of patients achieved near-complete skin clearance and more than 40% achieved complete clearance at 24 weeks, with a safety profile consistent with earlier studies.

The company said it intends to submit a new-drug application to the FDA in the second half of this year, and that it will present additional data from the trials later this month at a dermatology conference.

Alumis is also studying the drug in systemic lupus erythematosus, with midstage data expected in the third quarter.

Separately, the company said it raised about $345.1 million of gross proceeds from a January stock offering. Including existing cash and investments, Alumis expects to fund operations into the fourth quarter of 2027.

For the year-ended Dec. 31, Alumis reported a net loss of $243.3 million, compared with a loss of $294.2 million a year earlier.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

March 19, 2026 17:31 ET (21:31 GMT)