readthroughSign in
Aug 13, 2026Quarterly update

Alumis reports long-term ONWARD3 data, keeps NDA and LUMUS timelines on track

Alumis said 54% of psoriasis patients reached complete skin clearance at 48 weeks in ONWARD3 and reaffirmed a Q4 2026 NDA filing and Q3 2026 SLE readout for envudeucitinib.

Alumis Inc. reported second quarter 2026 results on August 13, 2026. The company said topline results from the ongoing ONWARD3 long-term extension study showed that 75% and 54% of patients achieved PASI 90 and PASI 100, respectively, after up to 48 weeks of continuous envudeucitinib treatment (n=773), with envudeucitinib well tolerated and a safety profile consistent with ONWARD1/2.1

Alumis said it remains on track to submit its New Drug Application to FDA for envudeucitinib in PsO in the fourth quarter of 2026.1 The company also said it anticipates potentially pivotal Phase 2b LUMUS topline data for envudeucitinib in SLE in the third quarter of 2026, a milestone with the potential to open the Type I interferon disease pathway for the TYK2 franchise.1

On the broader TYK2 pipeline, Alumis said it is prioritizing Sjögren's disease and cutaneous lupus erythematosus (CLE) as additional interferon-driven indications to pursue for envudeucitinib, with advancement decisions dependent on LUMUS Phase 2b results and disciplined capital allocation.1 For A-005, the company's CNS-penetrant TYK2 inhibitor, Alumis said it plans to initiate a Phase 2 biomarker trial in patients with Parkinson's disease in the first half of 2027.1

Separately, Alumis said it completed its strategic review of the lonigutamab program and decided to explore strategic alternatives for this asset.1 That decision came with a $41.8 million impairment loss related to the acquired IPR&D intangible asset associated with the lonigutamab program.1

On finances, Alumis reported cash, cash equivalents and marketable securities of $502.3 million as of June 30, 2026.1 The company said this is expected to fund operating expenses and capital expenditure requirements into the fourth quarter of 2027.1 Net loss for the quarter was $142.2 million, compared to net income of $59.3 million for the quarter ended June 30, 2025, which included a non-operating gain of $187.9 million related to the merger with ACELYRIN, Inc.1

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.