PureTech announces receipt of FDA Fast Track Designation for LYT-200 in AML

PureTech Health (PRTC) announced that the U.S. Food and Drug Administration has granted Fast Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia. “Fast Track designation is a process designed to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need,” the company stated. The FDA has also granted orphan drug designation to LYT-200 for the treatment of AML as well as a separate Fast Track designation for the treatment of recurrent/metastatic head and neck squamous cell carcinomas, in combination with anti-PD1 therapy. PureTech previously announced that it intends to advance LYT-200 via its Founded Entity, Gallop Oncology.