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Faeth Reports Positive Preliminary Phase 2 Topline Results from the PIK-201 Trial Evaluating PIKTOR in Combination with Paclitaxel in Patients with Advanced Endometrial Cancer

Key Takeaway: Faeth Therapeutics announced positive topline results from its Phase 2 PIK-201 trial. The trial evaluated PIKTOR, a combination of serabelisib and sapanisertib with paclitaxel, in patients with advanced endometrioid endometrial cancer. The results indicate effectiveness in patients with specific PAM pathway mutations.

Market Sentiment Analysis

POSITIVE FACTORS

  • Faeth reported positive topline results from the Phase 2 trial.
  • PIKTOR showed effectiveness in advanced endometrial cancer patients.
  • Combination therapy with paclitaxel demonstrated promising outcomes.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~40 mo
Low dilution risk
Lead asset
Serabelisib
Phase 2 · HR+ HER2- Breast Cancer

Full Press Release Details

AUSTIN, Texas--(BUSINESS WIRE)--Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, today announced topline clinical data from its Phase 2 trial (FTH-PIK-201; NCT06463028; GOG-3111) of PIKTOR, an investigational all-oral combination of serabelisib and sapanisertib, given with paclitaxel to patients with advanced endometrioid endometrial cancer and a PI3K/AKT/mTOR (PAM) pathway mutation who ha

Frequently Asked Questions

What is the PIK-201 trial?

The PIK-201 trial is a Phase 2 study evaluating PIKTOR in advanced endometrial cancer.

What does PIKTOR consist of?

PIKTOR is a combination of serabelisib and sapanisertib given with paclitaxel.

What were the results of the trial?

The trial reported positive topline results for patients with PAM pathway mutations.

Who were the patients in the trial?

Patients had advanced endometrioid endometrial cancer with specific mutations.

Last updated: Nov 9, 2026