Zenas Submits BLA for Obexelimab to FDA for IgG4-RD Treatment

Zenas BioPharma submitted a Biologics License Application to the U.S. Food and Drug Administration on May 28, 2026, seeking approval of obexelimab for immunoglobulin G4-related disease (IgG4-RD). The submission is aimed at the rare autoimmune disease which currently has no approved therapies. Obexelimab, a monoclonal antibody targeting CD19, met its primary endpoint in a Phase II trial, reducing disease flares. The privately held biotech did not disclose the FDA review timeline, but standard procedure involves a 60-day filing review followed by a 12-month evaluation if accepted. IgG4-RD affects an estimated 1 in 100,000 people in the U.S.