Alumis' Envudeucitinib Shows 54% PASI 100 at 48 Weeks, NDA Planned for Q4 2026

Alumis reported long-term clinical data showing that more than half of patients treated continuously with envudeucitinib achieved complete skin clearance after up to 48 weeks, strengthening the company's plans to seek U.S. approval for the oral psoriasis treatment. Topline results from the ONWARD3 long-term extension study showed that 54% of patients achieved PASI 100, a measure representing complete skin clearance, while 75% achieved PASI 90, representing at least a 90% improvement in psoriasis severity. The analysis included 773 patients who received continuous envudeucitinib treatment for up to 48 weeks.

Sixty-eight percent of patients with moderate-to-severe plaque psoriasis achieved PASI 90 at Week 24 in the ONWARD1 trial, a number that lands meaningfully above the roughly 50–55% PASI 90 benchmarks typically seen in late-stage oral TYK2 inhibitor programs. The Phase 3 data presented at AAD make clear the company intends to position envudeucitinib not as a me-too deucravacitinib competitor but as a step-change in what allosteric TYK2 inhibition can deliver orally. Quality-of-life improvements and itch relief preceded PASI 90 clearance, and over 30% of patients hit clear or almost-clear scalp by Week 4, a region notorious for poor response to oral agents. That early scalp signal, combined with sustained PASI 100 rates of 41% and 39.5% across the two trials at Week 24, gives Alumis a differentiation story rooted in body-site-specific data. The safety profile tracking consistent with Phase 2 removes the primary obstacle that could have complicated the NDA package.

Alumis said envudeucitinib remained well tolerated and maintained a safety profile consistent with its ONWARD1 and ONWARD2 studies. The company characterized the 54% PASI 100 result as the highest reported complete-clearance response rate among oral therapies for moderate-to-severe plaque psoriasis. Alumis remains on track to submit a New Drug Application to the FDA for envudeucitinib in moderate-to-severe plaque psoriasis during the fourth quarter of 2026.

The company is also evaluating the TYK2 inhibitor beyond psoriasis. Potentially pivotal Phase 2b LUMUS topline results in systemic lupus erythematosus are expected in the third quarter of 2026. SLE is a notoriously difficult efficacy environment, and a Phase 2b miss there would compress the asset's commercial ceiling sharply, regardless of what the psoriasis approval delivers. Depending on those results and capital-allocation considerations, Alumis plans to prioritize Sjögren's disease and cutaneous lupus erythematosus as additional indications for envudeucitinib.

Alumis is separately advancing A-005, a CNS-penetrant TYK2 inhibitor, with plans to begin a Phase 2 biomarker trial in patients with Parkinson's disease during the first half of 2027. The expanding development strategy reflects Alumis's effort to build what management describes as a broader TYK2 franchise rather than relying on a single psoriasis indication.

Alumis carries $569.5 million in cash against a $93.1 million quarterly burn, giving it runway into Q4 2027. The one number worth tracking from here is the PASI 100 rate at the Week 52 ONWARD3 long-term readout due in the second half of 2026: durable complete clearance at one year is what separates a strong oral therapy from a category-defining one, and the NDA reviewer will weigh it heavily against deucravacitinib's long-term data already in the public domain.