MoonLake Immunotherapeutics disclosed Phase 2 data showing a clinically meaningful benefit for its sole investigational drug in an aggressive inflammatory arthritis subtype, and said the results give the company confidence as it prepares an FDA submission. The data were shared with Endpoints News and framed as supportive of a regulatory filing pathway. MoonLake characterized the outcome as validation of its program and indicated readiness to engage regulators. Independent details on effect size, endpoints and patient population were limited in the company’s disclosure. The mid‑stage readout will determine whether MoonLake can advance toward a pivotal strategy and whether the benefit is durable and robust enough to support expedited regulatory discussions.
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