Serabelisib and sapanisertib (FTH-PIK-201) - (PIKTOR)

August 17, 2026: Faeth Therapeutics (NASDAQ: FTH) said the FDA granted Fast Track designation to sapanisertib plus serabelisib (PIKTOR) in combination with paclitaxel for advanced or recurrent endometrial cancer with a PI3K/AKT/mTOR pathway alteration in patients previously treated with platinum-based chemotherapy and an immune checkpoint inhibitor.

PIKTOR is an investigational oral combination of serabelisib, a PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor. The company said it is being studied in the Phase 2 FTH-PIK-201 trial in second-line advanced endometrial cancer, with topline data expected by year-end 2026.

Faeth also noted a second program: PIKTOR is being evaluated in the Phase 1b/2 FTH-PIK-101 trial in HR+/HER2- advanced breast cancer; the first patient was dosed in April, and interim data are expected in 2027.