Celcuity Inc. unveils new data on gedatolisib for advanced breast cancer in investor presentation
Reuters
Nov 14
<a href="https://laohu8.com/S/CELC">Celcuity Inc</a>. unveils new data on gedatolisib for advanced breast cancer in investor presentation
Celcuity Inc. has released new data from its Phase 3 VIKTORIA-1 clinical study evaluating gedatolisib in patients with HR+/HER2-, PIK3CA wild-type advanced breast cancer. The study showed that gedatolisib combinations met both primary endpoints by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to fulvestrant. Specifically, the triplet combination of gedatolisib, fulvestrant, and palbociclib achieved a median progression-free survival (mPFS) of 9.3 months versus 2.0 months for fulvestrant alone, reflecting a 7.3-month improvement. The company plans to submit a New Drug Application for the PIK3CA wild-type cohort in the fourth quarter of 2025. Celcuity is also advancing clinical trials of gedatolisib in other cancer types, including metastatic castration-resistant prostate cancer. As of the third quarter of 2025, the company reported cash and investments of $455 million, projected to fund operations through 2027. You can access the full presentation through the link below.
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