Posted by Michael Wonder on 22 Oct 2025
GondolaBio receives US FDA orphan drug and fast track designations for PORT-77 for the treatment of erythropoietic protoporphyria and X-linked protoporphyria
21 October 2025 - PORT-77 is currently being investigated in the Phase 2A proof of concept trial, GATEWAY, with the primary outcome of plasma PPIX reduction.
GondolaBio today announced that the US FDA has granted orphan drug designation and fast track designation to its affiliate, Portal Therapeutics, for PORT-77, an investigational oral, small molecule ABCG2 inhibitor, for the treatment of erythropoietic protoporphyria and X-linked protoporphyria.
