Alumis Inc. Reports Robust Phase 3 Results for Envudeucitinib in Plaque Psoriasis — Investor Update

Key Highlights

• Envudeucitinib, a next-generation oral TYK2 inhibitor, delivers strong efficacy and rapid onset in two pivotal Phase 3 trials for moderate-to-severe plaque psoriasis.
• Significant improvements in skin clearance, quality of life, and relief from itch and scalp psoriasis observed as early as Week 2–4.
• Favorable safety and tolerability profile; no new safety signals identified.
• Alumis plans to submit a New Drug Application to the FDA in the second half of 2026.
• Data presented as a late-breaking oral session at the 2026 American Academy of Dermatology (AAD) Annual Meeting.
• Potentially differentiated clinical profile versus existing and investigational oral therapies.
• Ongoing long-term extension and upcoming pivotal trials in other immune-mediated diseases, including lupus.

Detailed Analysis for Investors

Alumis Inc. (Nasdaq: ALMS) announced highly encouraging results from its Phase 3 ONWARD1 and ONWARD2 clinical trials evaluating envudeucitinib, a highly selective oral TYK2 inhibitor, for moderate-to-severe plaque psoriasis. The data were presented at the 2026 AAD Annual Meeting, a significant event for the dermatology and biopharma communities.

Clinical Efficacy

• PASI Responses: Envudeucitinib achieved robust skin clearance with PASI 90 responses (near-total clearance) by Week 16 in 59.9% and 53.1% of patients, rising to 68.0% and 62.1% by Week 24. PASI 100 (complete clearance) was achieved by 29.4% and 27.7% at Week 16, increasing to 41.0% and 39.5% at Week 24. Placebo response rates were under 5%, highlighting the drug’s efficacy.
• Scalp Psoriasis: Approximately 75% of treated patients with baseline scalp involvement achieved clear or almost clear scalp psoriasis (ss-PGA 0/1) by Week 24, with over 30% responding as early as Week 4 — a notable advance for a high-impact, difficult-to-treat area.
• Quality of Life & Itch Relief: By Week 12, about 50% of patients achieved DLQI 0/1, indicating minimal to no impact on quality of life. Meaningful itch relief, measured by a >4-point improvement on the pruritus scale, was observed as early as Week 2, addressing one of the most burdensome symptoms.

Safety Profile

• Envudeucitinib was generally well tolerated through Week 24, consistent with previous Phase 2 data. No clinically significant laboratory abnormalities or tuberculosis reactivation occurred.
• Most adverse events were mild, transient, and self-limited (headache, nasopharyngitis, upper respiratory tract infection, acne). No new safety signals were observed.

Strategic and Price-Sensitive Developments

• Regulatory Pathway: Alumis plans to submit a New Drug Application (NDA) to the U.S. FDA in the second half of 2026, a critical milestone that could significantly impact share value if successful.
• Long-Term Data: ONWARD3, the ongoing long-term extension study, will provide durability and maintenance data, further supporting regulatory and commercial positioning.
• Pipeline Expansion: Envudeucitinib is also being evaluated in LUMUS, a potentially pivotal Phase 2b trial for systemic lupus erythematosus, with topline data expected in Q3 2026. The pipeline includes additional TYK2 inhibitors and therapies for neuroinflammatory and neurodegenerative diseases, broadening commercial prospects.
• Market Need: With over 8 million adults affected by plaque psoriasis in the U.S., and about 25% suffering moderate-to-severe disease often inadequately controlled by current treatments, envudeucitinib’s efficacy and safety profile positions it as a potentially leading oral therapy, disrupting the market and creating significant value for shareholders.
• TYK2 Mechanism: TYK2 inhibition is a validated approach for multiple immune-mediated conditions, and envudeucitinib’s precision-engineered, allosteric inhibition delivers maximal 24-hour target engagement, distinguishing it from competitors.

Conference Call and Investor Access

Alumis will host a webcast for investors to review the Phase 3 ONWARD results at 5:00 pm MDT / 7:00 pm EDT on March 29, 2026. The presentation is also available on the company’s website, providing transparency and direct access to data for shareholders.

Implications for Shareholders

• These results significantly strengthen the case for envudeucitinib as a future market leader in oral psoriasis therapy. The high efficacy, early onset, and favorable safety profile, coupled with a clear regulatory path, are likely to influence investor sentiment and could drive share price appreciation.
• The ongoing long-term extension and expanded pipeline in other immune-mediated diseases create additional value inflection points in 2026 and beyond.
• Risks remain, including regulatory approval uncertainties, competition, and the need to maintain robust funding and IP protection. Shareholders should monitor future SEC filings and company updates for new developments.

About Alumis Inc.

Alumis is a late-stage biopharma company specializing in next-generation targeted therapies for immune-mediated diseases, leveraging proprietary data analytics and precision approaches. Its pipeline includes oral TYK2 inhibitors for psoriasis and lupus, as well as therapies for neuroinflammatory and thyroid eye diseases. For more information, visit www.alumis.com.

Disclaimer

This article contains forward-looking statements based on current information and expectations, which are subject to risks and uncertainties. Actual results may differ materially from those expressed or implied. Investors should review Alumis Inc.’s SEC filings, especially “Risk Factors,” for additional information. This article is for informational purposes only and is not investment advice. Please consult your financial advisor before making investment decisions.

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