Envudeucitinib Achieves 65% PASI 90 and Over 40% PASI 100 in Alumis Phase III Trials

ALMSALMS

In two Phase III ONWARD1 and ONWARD2 trials, envudeucitinib met co-primary endpoints of PASI 75 and sPGA 0/1 at Week 16, with 65% of patients achieving PASI 90 and over 40% attaining complete clearance by Week 24. It plans an FDA New Drug Application in H2 2026.

1. Upsized Public Offering Priced to Generate $300 Million in Gross Proceeds

Alumis Inc. today announced the pricing of an upsized underwritten public offering of 17.65 million shares of its common stock at $17.00 per share, resulting in approximately $300.0 million in gross proceeds before underwriting discounts, commissions and offering expenses. All shares are being sold by Alumis, with the offering expected to close on January 9, 2026, subject to customary closing conditions. Underwriters have been granted a 30-day option to purchase up to an additional 2.65 million shares at the same public offering price, less underwriting discounts and commissions. Joint book-running managers for the transaction include Morgan Stanley, Leerink Partners, Cantor Fitzgerald and Wells Fargo Securities, with Baird and Oppenheimer & Co. serving as co-lead managers. Proceeds are earmarked to advance clinical development, regulatory filings and commercial readiness for Alumis’s pipeline of oral TYK2 inhibitors and other targeted therapies.

2. Envudeucitinib Phase III Trials Deliver Robust Skin Clearance Outcomes

Alumis reported topline results from its global Phase III ONWARD1 and ONWARD2 trials of envudeucitinib, its next-generation oral TYK2 inhibitor, in adults with moderate-to-severe plaque psoriasis. Both trials met co-primary endpoints of Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0/1 at Week 16 with p-values below 0.0001, enrolling over 1,700 patients randomized 2:1:1 against placebo and active comparator. Across the two studies, 74% of patients achieved PASI 75 and 59% achieved sPGA 0/1 at Week 16, with responses deepening to an average of 65% reaching PASI 90 and more than 40% reaching complete clearance (PASI 100) by Week 24. Rapid separation from placebo was observed as early as Week 4. The safety profile was consistent with prior data, with most treatment-emergent adverse events being mild to moderate, including headache, nasopharyngitis and acne. Alumis plans to submit a New Drug Application to the FDA in the second half of 2026 and to present full data at an upcoming medical conference.

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