Envudeucitinib Demonstrates Superior Efficacy in Plaque Psoriasis: Alumis Advances Toward FDA Submission With Impressive Phase 3 Data

Alumis Inc. (ALMS) has delivered significant clinical validation for its promising lead candidate, marking a major milestone in the treatment of plaque psoriasis. The company’s advanced oral therapy, Envudeucitinib, has shown compelling efficacy in the latest phase 3 trial readouts, positioning it as a potential game-changer in a market currently dominated by limited competition.

Breaking Through in Plaque Psoriasis Treatment

Plaque psoriasis represents a substantial unmet medical need affecting over 8 million U.S. adults. This chronic, immune-mediated condition is characterized by painful, itchy, scaly patches that commonly appear on the scalp, face, hands, feet, and nails—areas that significantly impact patients’ quality of life. The underlying pathology involves dysregulation of IL-23 and IL-17 inflammatory pathways, which multiple therapeutic approaches now target through various drug classes including IL-23 inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, TNF-α inhibitors, and PDE-4 inhibitors.

Envudeucitinib: A Selective TYK2 Inhibitor Strategy

Envudeucitinib operates as a highly selective oral TYK2 inhibitor, designed to address these dysregulated inflammatory mediators at their source. The TYK2 inhibitor category currently represents a narrow therapeutic landscape, with only one FDA-approved agent—Bristol Myers Squibb’s Sotyktu—capturing the market since its late-2022 launch. Sotyktu’s commercial trajectory has been robust, generating $170 million in 2023, $246 million in 2024, and approximately $206 million during the first three quarters of 2025.

Superior Clinical Outcomes from Phase 3 Trials

Alumis’ ONWARD program comprises two parallel 24-week phase 3 trials (ONWARD1 and ONWARD2) alongside a long-term extension study (ONWARD3). The recently disclosed topline results demonstrate exceptional efficacy: approximately 65% of patients achieved PASI 90 skin clearance, while more than 40% reached PASI 100—the complete clearance benchmark—at week 24 across both trials. These outcomes position Envudeucitinib among the most efficacious oral therapies in this treatment class.

The long-term extension trial (ONWARD3) is now ongoing, enrolling patients who completed the primary phase 3 studies to evaluate durability and sustained benefit. Additional detailed data from ONWARD1 and ONWARD2 are expected to be presented at upcoming medical conferences, strengthening the regulatory dossier. Alumis plans to submit a New Drug Application to the FDA in the second half of 2025, moving toward potential market approval.

Expanding the Pipeline Beyond Plaque Psoriasis

Beyond plaque psoriasis, Envudeucitinib is also under investigation in a phase 2b trial for systemic lupus erythematosus, with topline data anticipated in Q3 2026. This diversification signals the company’s ambition to establish Envudeucitinib as a platform therapy across multiple immune-mediated disorders.

Market Response and Stock Performance

The clinical momentum has resonated strongly with investors. Alumis’ share price surged from $5.52 in mid-November to an intraday high of $23 last week, representing a 316% appreciation in approximately 60 days. The stock closed at $22.11, reflecting sustained investor confidence in the clinical and commercial potential of the Envudeucitinib program and the significant market opportunity within the plaque psoriasis treatment landscape.