Alumis Inc. reported that its Phase 3 ONWARD1 and ONWARD2 studies of envudeucitinib met all primary and secondary endpoints in patients with moderate‑to‑severe plaque psoriasis. Across more than 1,700 participants, 74 % achieved a 75 % improvement in the Psoriasis Area and Severity Index (PASI 75) and 59 % reached a static Physician Global Assessment of 0 or 1 (sPGA 0/1) at week 16. At week 24, 65 % of patients reached PASI 90 and over 40 % achieved complete clearance (PASI 100).
The high efficacy rates, particularly the 65 % PASI 90 and 40 % PASI 100, surpass the performance of the oral comparator apremilast and rival the best‑in‑class biologics that require injection. Envudeucitinib’s oral formulation offers a patient‑preferred route, potentially expanding adoption and market share. The safety profile mirrored that seen in Phase 2, with no new safety signals, reinforcing the drug’s risk‑benefit balance.
From a business perspective, the results de‑risk the development pathway and strengthen the company’s competitive positioning in a multi‑billion‑dollar psoriasis market. Alumis’s cash balance of $377.7 million, as of September 30, 2025, provides a runway through 2027, allowing the firm to fund the upcoming FDA New Drug Application filing slated for the second half of 2026 and to support commercialization efforts. The data also bolster the company’s broader pipeline, as success in psoriasis enhances the likelihood of future approvals in systemic lupus erythematosus and other autoimmune indications.
Chief Medical Officer Dr. Jörn Drappa emphasized that the results confirm the full therapeutic potential of TYK2 inhibition: “Envudeucitinib blocks both IL‑23 and IL‑17 pathways, delivering comprehensive disease control.” He added that the oral route and superior efficacy could position the drug as a best‑in‑disease option, potentially capturing a significant share of the psoriasis market and creating a platform for expansion into other inflammatory diseases.
Analysts reacted strongly to the data, citing the high PASI 90/100 rates and oral advantage as key drivers of the market’s enthusiasm. The announcement has already prompted a reevaluation of the company’s valuation and has led to upward revisions in price targets by several analysts, reflecting confidence in the drug’s commercial prospects.
Alumis plans to present additional data at an upcoming medical meeting and will file the NDA with the FDA in the second half of 2026. The company will also continue to monitor long‑term safety and efficacy in its ongoing Phase 3 extension studies, positioning itself for a potential launch in the U.S. and international markets in the next 12–18 months.
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