LAKEFRONT BIOTHERAPEUTICS NV FDA granted Orphan Drug Designation to gamgertamig for pemphigus, a regulatory milestone for Lakefront.
Lakefront Biotherapeutics announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to gamgertamig for the treatment of pemphigus. Gamgertamig was previously granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of autoimmune hemolytic anemia and immune thrombocytopenia. The drug is being developed by Lakefront in collaboration with Gilead Sciences, with ongoing clinical trials in autoimmune diseases actively enrolling and expansion of the clinical trials program anticipated in 2027. Gamgertamig is an investigational BCMAxCD3 bispecific T cell engager currently in Phase 2 studies and is expected to enter registrational studies in 2027.
LAKEFRONT BIOTHERAPEUTICS NV FDA granted Orphan Drug Designation to gamgertamig for pemphigus, a regulatory milestone for Lakefront.
Gilead Sciences IncGilead collaborates on gamgertamig, which received FDA Orphan Drug Designation for pemphigus, advancing its pipeline.