— Fast Track designation applies to sapanisertib and serabelisib (PIKTOR) in combination with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR pathway alteration

— Faeth expects topline data from its ongoing Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201) by year-end 2026

Faeth Therapeutics (NASDAQ:FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of sapanisertib and serabelisib (PIKTOR) with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI).