News Related to Assessment of SpondyloArthritis International Society 40 Response Criteria

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MoonLake on Track for HS BLA Submission; Relay's Zovegalisib Receives FDA Breakthrough Status

Feb 24, 2026

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 Reports Positive Phase 2 Results for Sonelokimab in Axial Spondyloarthritis

Feb 13, 2026

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.