Alumis Inc. (ALMS) News & EventsALMSAlumis Inc.

Alumis to Submit New Drug Application for Envudeucitinib in Q4

"Envudeucitinib's Phase 3 clinical validation in PsO, reinforced by our ONWARD3 long-term data, demonstrates the power of maximal TYK2 inhibition in IL-23/IL-17-driven diseases, and our anticipated Phase 2b LUMUS readout in SLE may substantiate its role in IFN-driven diseases -- potentially unlocking broader potential of our TYK2 franchise," said Martin Babler, President and Chief Executive Officer of Alumis. "The ONWARD3 long-term data delivered the highest reported PASI 100 response rate among oral therapies, positioning envudeucitinib to set a new standard in PsO. We remain on track to submit a New Drug Application for envudeucitinib in moderate-to-severe plaque psoriasis in Q4 with the goal, if approved, of bringing this new oral treatment option to patients."

Alumis Announces ONWARD3 Study Results, Highest PASI 100 Response Rates

Alumis announced topline results from the ongoing ONWARD3 long-term extension study. Data confirm envudeucitinib delivered leading skin clearance and the highest reported Psoriasis Area and Severity Index 100 response rates among existing and investigational oral therapies. Envudeucitinib is an investigational, next-generation oral TYK2 inhibitor precision-engineered for maximal 24-hour target inhibition. A total of 1,509 patients entered ONWARD3 from ONWARD1 or ONWARD2, reflecting a robust rollover rate of greater than 85%. A non-responder imputation analysis was conducted in 773 of these patients from the envudeucitinib arms who received up to 48 weeks of continuous treatment. Topline results include: 75% and 54% of patients achieved PASI 90 and PASI 100, respectively. Among patients who entered ONWARD3 with PASI 90 and PASI 100 responses, approximately 90% and 80%, respectively, sustained their skin clearance for the reported duration of the extension study. Results from a separate integrated NRI analysis across the ONWARD program -evaluating 890 patients originally randomized to envudeucitinib in ONWARD1/2, including those who did not transition into ONWARD3-demonstrated that 66% and 47% of patients who received 48 weeks of envudeucitinib achieved PASI 90 and PASI 100, respectively. Treatment with envudeucitinib in ONWARD3 continued to be well tolerated, with a safety profile consistent with ONWARD1/2 and no new safety signals observed. Alumis plans to present additional results from the ONWARD program at upcoming medical meetings and to submit a New Drug Application to the FDA seeking approval for envudeucitinib for the treatment of moderate-to-severe plaque psoriasis in the fourth quarter of this year. Topline data from the LUMUS Phase 2b trial of envudeucitinib in systemic lupus erythematosus is expected in the third quarter of 2026.

Alumis Stock Rises 10.3% to $23.06

Alumis is up 10.3%, or $2.16 to $23.06.