<a href="https://www.fiercebiotech.com/biotech/celcuitys-gedatolisib-beats-novartis-piqray-phase-3-breast-cancer-study" hreflang="en">Celcuity’s gedatolisib beats Novartis’ Piqray in phase 3 breast cancer study</a>
Celcuity’s gedatolisib has outperformed Novartis’ Piqray in a phase 3 breast cancer trial, achieving significant improvements in progression-free survival, which enables the company to file a supplemental new drug application with the FDA. The positive results have led to a 15% increase in Celcuity's stock price and set the stage for potential approval in both PIK3CA-wild-type and PIK3CA-mutant breast cancer.
Celcuity's phase 3 trial success with gedatolisib, showing superiority over Novartis' Piqray in treating PIK3CA-mutant breast cancer, positions it for an FDA supplemental new drug application and potential label expansion. This development, alongside plans to seek European approval and partner internationally, signals a robust market opportunity, particularly given forecasts of $2.1 billion in sales by 2032. Watch for detailed phase 3 data at the upcoming ASCO meeting, especially regarding progression-free survival and safety profile, to better gauge gedatolisib's competitive positioning and potential impact on precision medicine in oncology.