Gamgertamig (OM336)

August 24, 2026: Lakefront Biotherapeutics NV (Euronext/NASDAQ: LKFT) said the FDA granted Orphan Drug Designation to gamgertamig for pemphigus. The company said gamgertamig had previously received FDA Fast Track and Orphan Drug Designation for autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).

Gamgertamig, a BCMAxCD3 bispecific T-cell engager partnered with Gilead Sciences, is in ongoing autoimmune studies: a Phase 1b trial in autoimmune cytopenias including ITP and AIHA (NCT07083960) in Australia and the U.S., and a Phase 1b trial in seropositive autoimmune diseases including idiopathic inflammatory myositis, Sjögren’s disease, pemphigus vulgaris, and pemphigus foliaceus (NCT07229144) in Australia, New Zealand, the Czech Republic, and Japan.

Lakefront said additional proof-of-concept basket studies in other autoimmune indications are expected, with expansion of the clinical program anticipated in 2027. The release also states gamgertamig is currently in Phase 2 studies and is expected to enter registrational studies in 2027.