Faeth Therapeutics Shares Rise on FDA Fast-Track Designation for Cancer Treatment
By Anvee Bhutani
Faeth Therapeutics shares rose Monday morning after the clinical-stage oncology company said the Food and Drug Administration granted fast-track designation to its experimental cancer treatment.
Shares were recently up 5% at $34.06.
The designation applies to PIKTOR, a combination of sapanisertib and serabelisib with paclitaxel, for patients with advanced or recurrent endometrial cancer whose tumors have alterations in the PI3K/AKT/mTOR pathway and whose disease has progressed after platinum-based chemotherapy and an immune checkpoint inhibitor.
Faeth said the designation is intended to facilitate development and regulatory review of treatments for serious conditions with unmet medical needs.
The company expects topline data from an ongoing Phase 2 trial of PIKTOR in second-line advanced endometrial cancer by the end of 2026.
PIKTOR is an investigational, all-oral combination designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. The treatment also is being studied in a Phase 1b/2 trial for advanced HR-positive, HER2-negative breast cancer, with interim data expected in 2027.
Write to Anvee Bhutani at anvee.bhutani@wsj.com
(END) Dow Jones Newswires
August 17, 2026 10:31 ET (14:31 GMT)
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