Axial spondyloarthritis is a chronic inflammatory rheumatic disease that primarily affects the spine and sacroiliac joints. It causes inflammatory back pain and stiffness and can progress to structural damage if untreated.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07148414 |
A Study of SPY072 in Rheumatic Disease |
RECRUITING | PHASE2 |
| NCT06460805 |
axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis |
RECRUITING | NA |
