MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on immunology therapeutics for inflammatory skin and joint diseases. The company is advancing sonelokimab, a tri-specific Nanobody, to address major unmet medical needs.
MoonLake Immunotherapeutics says FDA feedback indicates sufficient data to support a U.S. BLA for hidradenitis suppurativa without additional efficacy trials, while Relay Therapeutics received FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant breast cancer.
MoonLake Immunotherapeutics announced positive topline results from its Phase 2 S-OLARIS trial of sonelokimab in axial spondyloarthritis, with 81% of patients achieving ASAS40 response by Week 12. The company ended Q4 2025 with $394 million in cash.
