Swedish Orphan Biovitrum AB (publ)

FDA Grants Fast Track Designation to Sobi's Pacritinib for VEXAS Syndrome

- The FDA has granted Fast Track designation to Sobi's dual IRAK1/JAK2 inhibitor pacritinib for the treatment of VEXAS syndrome, a rare autoinflammatory disease with no approved therapies. - Pacritinib is being evaluated in the Phase 2 PAXIS trial, the first randomized study in VEXAS, assessing whether the drug prevents disease flares after glucocorticoid tapering. - PAXIS is a randomized, multicenter, double-blind, placebo-controlled, dose-finding trial followed by an open-label period, with topline data expected in 2027. - Sobi's Chief Medical Officer Lydia Abad-Franch said the designation recognizes pacritinib's potential and reflects the critical need for new options in this debilitating condition.