GSK plc Form 6-K Filing Summary

GSK plc announced on June 12, 2026, that their drug momelotinib has received Orphan Drug Designation (ODD) from both the US FDA and the European Medicines Agency (EMA) for the treatment of VEXAS syndrome. VEXAS syndrome is a rare and severe autoimmune disorder with a high mortality rate and currently no approved treatments. The ODDs are a significant step in the development of momelotinib for this condition. Clinical trials, including the planned phase II/III ATLAS trial, are underway to further evaluate the drug's efficacy and safety. Momelotinib is a JAK inhibitor that targets JAK1, JAK2, and ACVR1, and it is already approved in several regions for treating myelofibrosis with anemia. This designation is expected to support ongoing development and regulatory evaluations for VEXAS syndrome.