envudeucitinib (ESK-001) / Alumis, Haisco - LARVOL DELTA

Envudeucitinib, an allosteric TYK2 inhibitor, inhibits SLE-relevant type I IFN biomarkers in skin using spatial transcriptomics (ACR Convergence 2026) - No abstract available

Biomarker • Inflammatory Arthritis • TYK2

Envudeucitinib (ESK-001) in moderate-to-severe plaque psoriasis: 24-week results from the randomized, double-blind, active comparator- and placebo-controlled, Phase 3 ONWARD1 and 2 studies (ACR Convergence 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis

Envudeucitinib (ESK-001) in moderate-to-severe plaque psoriasis: 24-week results from the randomized, double-blind, active comparator- and placebo-controlled, Phase 3 ONWARD1 and 2 studies (EADV 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis

Envudeucitinib, an oral allosteric TYK2 inhibitor, suppresses inflammatory supraspinous keratinocyte states in psoriasis skin (EADV 2026) - No abstract available

Dermatology • Immunology • Psoriasis • TYK2

The Role of TYK2 Inhibitors in the Pathogenesis and Treatment of Psoriasis. (PubMed, J Clin Aesthet Dermatol) - "TYK2 inhibition represents a significant advancement for the treatment of psoriasis. Continued research will enable optimization of these agents in managing psoriasis and related immune-mediated diseases."

Journal • Review • Dermatology • Immunology • Psoriasis • TYK2

Alumis Announces Topline Results from Envudeucitinib Phase 2b Trial in Systemic Lupus Erythematosus (SLE) (GlobeNewswire) - "LUMUS trial did not meet its primary and secondary endpoints in the overall trial population. Robust responses in the prespecified subgroup of patients with high interferon gene signature (IFNGS-high) support moving forward with Phase 3 development in SLE. Pharmacodynamic data substantiate envudeucitinib’s potential in interferon-driven immune-mediated diseases. Envudeucitinib was generally well tolerated with no new safety signals observed."

P2b data • Systemic Lupus Erythematosus

Alumis remains on track to submit an NDA for envudeucitinib in moderate-to-severe plaque psoriasis in 4Q 2026 (GlobeNewswire)

FDA filing • Plaque Psoriasis

Systemic Treatment of Psoriasis: Current Evidence on Efficacy and Safety. (PubMed, J Dermatol) - "Older conventional systemic agents, such as cyclosporin, acitretin, or methotrexate, remain useful in selected settings, especially when treatment options are limited by cost or availability, when short-term disease control is needed, or when the patient prefers these treatments...Biologics targeting TNF-α or anti-IL-12/23p40 ustekinumab have established the biologic treatment era, and remain clinically relevant, especially for patients having psoriatic arthritis or prioritizing long-term safety...Targeted oral therapies increase options for patients who prefer non-injectable treatment; established or emerging agents include apremilast, deucravacitinib, icotrokinra, zasocitinib, envudeucitinib, and orismilast. Emerging IL-17-directed agents, including sonelokimab and izokibep, may further refine pathway targeting. Selection of treatment should be decided dependently on the completeness of skin clearance achieved, speed and duration of responses, effectiveness on..."

Journal • Review • Candidiasis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • TNFA

Anticipated 2026 Milestones (GlobeNewswire) - "Envudeucitinib in Moderate-to-Severe Plaque Psoriasis - Long-term data: Phase 2, two-year safety data (2H 2026)."

P2 data • Plaque Psoriasis

Topline data from the LUMUS Phase 2b trial of envudeucitinib in systemic lupus erythematosus is expected in the third quarter of 2026 (GlobeNewswire)

P2b data • Systemic Lupus Erythematosus

Alumis…announced topline results from the ongoing ONWARD3 long-term extension (LTE) study (GlobeNewswire) - "Data confirm envudeucitinib delivered leading skin clearance and the highest reported Psoriasis Area and Severity Index (PASI) 100 response rates among existing and investigational oral therapies....A total of 1,509 patients entered ONWARD3....Topline results include: 75% and 54% of patients achieved PASI 90 and PASI 100, respectively. Among patients who entered ONWARD3 with PASI 90 and PASI 100 responses, approximately 90% and 80%, respectively, sustained their skin clearance for the reported duration of the extension study....Alumis plans to present additional results from the ONWARD program at upcoming medical meetings and to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for envudeucitinib for the treatment of moderate-to-severe plaque psoriasis in the fourth quarter of this year."

FDA filing • P3 data: top line • Plaque Psoriasis

ESK-001-007: Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis (clinicaltrials.gov) - P2 | N=165 | Active, not recruiting | Sponsor: Alumis Inc | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Envudeucitinib, an allosteric TYK2 inhibitor, inhibits SLE-relevant type I IFN biomarkers in skin using spatial transcriptomics (EULAR 2026) - "This is being investigated in the 52-week SLE LUMUS study which evaluates doses of up to 40 mg BID with a 52-week long term extension. Topline results from LUMUS are expected Q3 2026."

Biomarker • Immunology • Inflammatory Arthritis • Lupus • Psoriasis • Systemic Lupus Erythematosus • TYK2

An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Alumis Inc | Recruiting ➔ Completed | N=48 ➔ 32 | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hepatology

Anticipated 2026 Milestones (GlobeNewswire) - "Envudeucitinib in Moderate-to-Severe Plaque Psoriasis: Long-term data - ONWARD3 topline data and Phase 2, two-year safety data (2H 2026); NDA submission (4Q 2026)...Envudeucitinib in SLE; Potentially pivotal Phase 2b SLE topline data (3Q 2026)...Update on unified TYK2 franchise development strategy, including evaluation of additional indications (2Q 2026); Initiate Phase 1 trial (2H 2026)."

New P1 trial • P2 data • P3 data: top line • Pipeline update • Plaque Psoriasis • Systemic Lupus Erythematosus

Envudeucitinib, an allosteric TYK2 inhibitor, inhibits TYK2-relevant biomarkers in skin using spatial transcriptomics (SID 2026) - "Results were generally consistent with previously reported bulk RNA-seq data. In STRIDE, spatial transcriptomics showed envudeucitinib achieved robust suppression of pathogenic IL-23 and IL-17 pathways in psoriasis-relevant skin cell types such as keratinocytes and myeloid/T cell subsets."

Biomarker • Immunology • Plaque Psoriasis • Psoriasis • CCL19 • CCR7 • IL17A • IL23A • TYK2

ONWARD 2: A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (clinicaltrials.gov) - P3 | N=862 | Completed | Sponsor: Alumis Inc | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

ONWARD 1: A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=912 | Completed | Sponsor: Alumis Inc | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

From Convenience to Clinical Efficacy: Selective TYK2 Inhibition in Psoriasis and the Evolving Role of Next-Generation Oral Targeted Therapies. (PubMed, Pharmaceutics) - "Selective TYK2 inhibitors, such as deucravacitinib, envudeucitinib, and zasocitinib, act through a unique allosteric mechanism by binding to the regulatory pseudokinase domain (JH2) rather than the enzyme's catalytic domain...Clinical trials (POETYK PSO-1 and PSO-2) and long-term extension studies demonstrate that deucravacitinib provides superior efficacy compared to the first-generation oral small molecule apremilast, with high and sustained response rates...Selective TYK2 inhibition bridges the therapeutic gap, providing an optimal balance of efficacy and oral convenience. With the potential to improve patient adherence and quality of life, these agents represent a promising option to become a first-line oral systemic therapy for psoriasis."

Journal • Review • Cardiovascular • Dermatology • Immunology • Infectious Disease • Oncology • Psoriasis • Venous Thromboembolism • IL17A • IL23A • TYK2

Shifting Role of Oral Therapies in Psoriasis: Unmet Needs and Perspectives on Current and Emerging Therapies, and Evolving Treatment Sequencing Among Dermatologists. (AAD 2026) - " Deucravacitinib gained first-line traction, with dermatologists increasingly delaying biologic initiation...Pipeline interest shifted year-over-year: oral IL-17 and aIL-23R mechanisms remained most valued (>83%), but icotrokinra (oral aIL-23R) emerged as the leading candidate, with aIL-23R awareness surpassing IL-17 agents and >60% of dermatologists favoring icotrokinra for first-line use, while TYK2 inhibitors (envudeucitinib, zasocitinib) were increasingly viewed as later-line options... Dermatologists report an expanding role for oral therapies in PsO. Broader availability of effective oral agents is expected to further delay biologic initiation, representing a paradigm shift in PsO management."

Dermatology • Immunology • Psoriasis • TYK2

Envudeucitinib, a Potent, Next-Generation, Allosteric Inhibitor of TYK2: A Narrative Review. (PubMed, Dermatol Ther (Heidelb)) - "These findings were corroborated in a phase 2 study in adults with moderate-to-severe plaque psoriasis; envudeucitinib showed maximal TYK2 inhibition at higher doses (40-80 mg daily), patients demonstrated significant and increasing efficacy responses through week 52, and the safety profile was favorable. The efficacy and safety of envudeucitinib are being further evaluated in the ongoing phase 3 ONWARD studies."

Journal • Review • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Psoriasis • Systemic Lupus Erythematosus • IL12A • IL17A • JAK1 • JAK2 • TYK2

Envudeucitinib (ESK-001) in moderate-to-severe plaque psoriasis: 24-week results from the randomized, double-blind, active comparator- and placebo-controlled, Phase 3 ONWARD 1 and 2 studies (AAD 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis

Envudeucitinib Attenuates Inflammatory Biomarkers in Plaque Psoriasis at Both a Proteomic and Transcriptomic Level: A Subgroup Analysis of Tape Strip Biomarkers from the STRIDE Phase 2 Clinical Trial (AAD 2026) - "Conclusion In moderate-to-severe psoriasis, envudeucitinib achieved robust suppression of pathogenic IL-23 and interferon-related pathways at transcriptomic and proteomic levels, underscoring its potential as an effective therapeutic strategy. Non-invasive tape-strip biomarker collection demonstrated concordance with biopsies, supporting its use for monitoring in clinical settings."

Biomarker • Clinical • P2 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis • IL17A • IL23A • TYK2

Alumis…announced new data from its Phase 3 ONWARD1 and ONWARD2 clinical trials evaluating envudeucitinib, a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor for moderate-to-severe plaque psoriasis (GlobeNewswire) - "The data were presented in a late-breaking oral session at the 2026 AAD Annual Meeting. Envudeucitinib demonstrated robust skin clearance, achieving high thresholds of clinical response at Week 16 that continued to deepen through Week 24 in both trials. Psoriasis Area and Severity Index (PASI) 90 responses, which emerged as early as Week 4, were achieved by 59.9% and 53.1% of envudeucitinib patients at Week 16 (and by 4.8% and 4.3% of placebo patients), increasing to 68.0% and 62.1% at Week 24. PASI 100 responses followed a similar trajectory, with 29.4% and 27.7% of envudeucitinib patients achieving complete skin clearance at Week 16 (as compared to 0.9% and 0.9% of placebo patients), rising to 41.0% and 39.5% at Week 24."

Late-breaking abstract • P3 data • Psoriasis

Alumis Announces Late-Breaker Oral Presentation of Phase 3 Data for Envudeucitinib in Moderate-to-Severe Plaque Psoriasis at 2026 American Academy of Dermatology Annual Meeting (GlobeNewswire) - "Phase 3 data presentation highlighting results from the ONWARD1 and ONWARD2 clinical trials of envudeucitinib. Phase 2 STRIDE e-poster presentation to describe disease biomarker activity of envudeucitinib."

Biomarker • Clinical data • Late-breaking abstract • Psoriasis