MoonLake Immunotherapeutics disclosed Phase 2 data showing a clinically meaningful benefit in patients with an aggressive inflammatory arthritis and told Endpoints News it has confidence ahead of an FDA submission. The company plans to use the Phase 2 readout to support regulatory filing discussions and refine its pivotal plans. MoonLake’s communication frames the result as sufficient to justify near-term engagement with regulators; the company is positioning for an expedited development path while preparing for confirmatory studies. Clinicians and investors will watch whether the Phase 2 endpoints and safety profile translate into a clear single pivotal pathway.