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MoonLake Immunotherapeutics (MLTX)

MoonLake Immunotherapeutics operates as a clinical-stage biopharmaceutical company, concentrating its efforts on discovering and developing novel therapies. The company's primary focus is the advancement of Sonelokimab, an innovative, investigational Nanobody-based treatment engineered to target inflammatory conditions. Currently, Sonelokimab is undergoing mid-stage (Phase II) clinical trials for a range of inflammatory diseases, including hidradenitis suppurativa, psoriatic arthritis, and both ankylosing spondylitis and radiographic axial spondyloarthritis. Established in 2021, MoonLake Immunotherapeutics is based in Zug, Switzerland.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

MoonLake Immunotherapeutics logo

MoonLake Immunotherapeutics

NASDAQ:MLTXHealthcare
-6.28%$11.78
AH$11.70-0.68%vs close
Mkt Cap$1B
Float54.6M
O/S85.11M
Vol
$ Vol
RVOL
Inst Own86.0%
SI14.3%
Earnings
Dilution
MoonLake Immunotherapeutics logoNASDAQ:MLTX$11.78-6.28%
Upcoming Catalysts
  • sonelokimabPDUFA
    hidradenitis suppurativa
    Cash runway at this date: 9mo
    End of Nov 2026~28d8-K
Phase Distribution
10 lead-sponsored trials·5 active·5 completed
Phase 11
Phase 22
Phase 37

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 3
    Completed

    Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

    Sonelokimab, Placebo

    Hidradenitis Suppurativa

    Enrollment
    418
    Start
    May 2024
    Primary Completion
    Aug 2025
    Completion
    May 2026
    NCT06411379
  • Phase 3
    Completed

    A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

    Sonelokimab, Placebo

    Hidradenitis Suppurativa

    Enrollment
    422
    Start
    May 2024
    Primary Completion
    Sep 2025
    Completion
    May 2026
    NCT06411899
  • Phase 3
    Active, not recruiting

    Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug

    Sonelokimab, Placebo

    Arthritis, Psoriatic

    Enrollment
    960
    Start
    Oct 2024
    Primary Completion
    May 2026
    Completion
    Feb 2027est.
    NCT06641076
  • Phase 3
    Active, not recruiting

    Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

    Sonelokimab, Placebo

    Arthritis, Psoriatic

    Enrollment
    600
    Start
    Oct 2024
    Primary Completion
    Jan 2027est.
    Completion
    Sep 2027est.
    NCT06641089
  • Phase 3
    Active, not recruiting

    An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)

    Sonelokimab

    Hidradenitis Suppurativa

    Enrollment
    35
    Start
    Dec 2024
    Primary Completion
    Sep 2026est.
    Completion
    Sep 2026est.
    NCT06768671
  • Phase 3
    Enrolling by invitation

    A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa

    Sonelokimab

    Hidradenitis Suppurativa

    Enrollment
    835
    Start
    Jun 2025
    Primary Completion
    Jun 2028est.
    Completion
    Jun 2028est.
    NCT07007637
  • Phase 3
    Enrolling by invitation

    A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis

    Sonelokimab

    Arthritis, Psoriatic

    Enrollment
    1,560
    Start
    Nov 2025
    Primary Completion
    Feb 2028est.
    Completion
    Feb 2028est.
    NCT07223138
  • Phase 2
    Completed

    Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

    Sonelokimab (M1095), Adalimumab

    Hidradenitis Suppurativa

    Enrollment
    234
    Start
    Apr 2022
    Primary Completion
    May 2023
    Completion
    Aug 2023
    NCT05322473
  • Phase 2
    Completed

    Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

    Sonelokimab, Placebo

    Arthritis, Psoriatic

    Enrollment
    207
    Start
    Dec 2022
    Primary Completion
    Sep 2023
    Completion
    Jan 2024
    NCT05640245
  • Phase 1
    Completed

    An Open-label Study in Healthy Adults to Evaluate the Relative Bioequivalence of a Single-dose Administration of Sonelokimab Either by a Prefilled Syringe or an Autoinjector

    Sonelokimab, Sonelokimab

    Relative Bioequivalence

    Enrollment
    120
    Start
    Jun 2025
    Primary Completion
    Nov 2025
    Completion
    Nov 2025
    NCT06994936
Search ClinicalTrials.gov for “MoonLake Immunotherapeutics”