U.S. FDA Grants Orphan Drug Designation to Gamgertamig for the Treatment of Pemphigus
Lakefront Biotherapeutics announced that the FDA has granted Orphan Drug Designation to gamgertamig for treating pemphigus, expanding on previous Fast Track and Orphan Drug designations for autoimmune hemolytic anemia and immune thrombocytopenia. The drug, developed in collaboration with Gilead Sciences, is currently in Phase 1b trials with expansion anticipated in 2027 and registrational studies expected in 2027.