Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor In the cohort, the gedatolisib triplet showed mPFS of 11.1 vs. 5.6mos., & an ORR…

ByRidhi RastogiJune 3, 2026

NEWS

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor The trial met its 1EP, with gedatolisib triplet improving PFS vs alpelisib + fulvestrant, while…

ByRidhi RastogiMay 4, 2026

NEWS

The US FDA Accepts Celcuity’s Gedatolisib NDA under Priority Review to Treat HR+/HER2- Breast Cancer

Shots: The US FDA has accepted NDA under priority review of gedatolisib in HR+/ HER2-, PIK3CA wild-type advanced breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jul 17, 2026) NDA was supported by data from the PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2-…

ByRidhi RastogiJanuary 22, 2026

NEWS

The US FDA Receives Celcuity’s NDA for Gedatolisib to Treat Advanced Breast Cancer

Shots: The US FDA has received an NDA of gedatolisib under the RTOR program for the treatment of HR+, HER2-, advanced breast cancer NDA was supported by data from PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs fulvestrant in HR+/HER2- advanced breast cancer pts Trial showed that gedatolisib…

ByRidhi RastogiNovember 18, 2025

INSIGHTS+

Know Your Investor: RA Capital Management LLC

Shots: PharmaShots’ second dose of the Know Your Investor series focuses on RA Capital Management LLC. Know Your Investor is an earnest effort from PharmaShots to acquaint our readers with leading Investors and venture capital firms in the healthcare industry Founded in 2002, RA Capital forged ahead to become a key investor in life science…

BySenior EditorAugust 31, 2023

TOP 20

Top 20 Oncology Companies Based on 2021 Oncology Segment Total Revenue

Shots: Oncology focuses on the study, diagnosis, prevention, and treatment of cancer based on the treatment option and it’s divided into 3 major areas including medical oncology, radiation oncology, and surgical oncology The advancements in cell and gene therapies have provided pharmaceutical companies with a unique set of ground-breaking tools for the development of more…

ByPrince GiriSeptember 8, 2022

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

The US FDA Accepts Celcuity’s Gedatolisib NDA under Priority Review to Treat HR+/HER2- Breast Cancer

The US FDA Receives Celcuity’s NDA for Gedatolisib to Treat Advanced Breast Cancer

Know Your Investor: RA Capital Management LLC

Top 20 Oncology Companies Based on 2021 Oncology Segment Total Revenue

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