Other Events ·
MoonLake submits BLA for sonelokimab in hidradenitis suppurativa; reports Q3 cash of $498.5M
MLTXMoonLake Immunotherapeutics
MoonLake Immunotherapeutics submitted a Biologics License Application to the FDA on September 30, 2026, seeking approval for sonelokimab to treat moderate-to-severe hidradenitis suppurativa in adults and adolescents aged 12 and older. The company also reported positive Week 16 results from its Phase 3 IZAR-1 trial in psoriatic arthritis, where all clinical endpoints were met for the 60 mg induction dose. Additionally, enrollment was completed in the Phase 3 IZAR-2 PsA trial, with initial topline results expected in Q1 2027. Financially, MoonLake ended the third quarter of 2026 with $498.5 million in cash and short-term marketable debt securities, projecting a runway to mid-2028. The company operates as a clinical-stage biopharmaceutical firm developing next-generation therapies for inflammatory diseases.