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Lakefront Biotherapeutics announced that the U.S. FDA granted Orphan Drug Designation for gamgertamig to treat pemphigus
GLPGFLakefront Biotherapeutics NV
Lakefront Biotherapeutics announced that the U.S. FDA granted Orphan Drug Designation for gamgertamig to treat pemphigus. The company also noted that gamgertamig, developed in collaboration with Gilead Sciences and licensed from Keymed Biosciences, previously received Fast Track and Orphan Drug Designations for autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Ongoing Phase 1b trials are active in Australia, the United States, New Zealand, the Czech Republic, and Japan. The company anticipates expanding its clinical program with proof-of-concept basket studies in 2027 as it advances toward registrational studies for this BCMAxCD3 bispecific T cell engager. Lakefront Biotherapeutics is a biotechnology company developing immunology and inflammation treatments.