# Celcuity announces publication of efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib in the Journal of Clinical Oncology.

*biotech · news · 2026-03-09 · The Manila Times*

## Key points

- The VIKTORIA-1 trial showed gedatolisib triplet increased median PFS to 9.3 months from 2.0 months.
- Gedatolisib’s broad inhibition of multiple PI3K/AKT/mTOR nodes differentiates it from current single-target inhibitors.
- In the PIK3CA WT cohort, the gedatolisib triplet reduced disease progression or death risk by 76%.
- FDA has granted Priority Review to Celcuity’s gedatolisib NDA with a target date of July 17, 2026.

**Companies:** Celcuity Inc.
**Countries:** United States

[Read the full story on The Manila Times](https://www.manilatimes.net/2026/03/10/tmt-newswire/globenewswire/celcuity-announces-publication-of-results-from-pik3ca-wild-type-cohort-of-phase-3-viktoria-1-study-of-gedatolisib-regimens-in-hrher2-advanced-breast-cancer-in-journal-of-clinical-oncology/2296445)

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