Latest News for: pik3ca
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Relay Therapeutics Announces Zovegalisib Granted Breakthrough Therapy Designation by U.S. FDA for PIK3CA-mutant, HR+/HER2- Advanced ...
Nasdaq Globe Newswire 03 Feb 2026
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Relay Therapeutics Announces Zovegalisib Granted Breakthrough Therapy Designation by U.S. FDA for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer (Form 8-K) (Relay Therapeutics Inc)
Public Technologies 03 Feb 2026
for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer ... Specifically, the application included data across all PIK3CA mutations (kinase and non-kinase) for two doses with comparable exposures ... About PIK3CA-mutated, HR+/HER2- Advanced Breast Cancer.
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Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer
Nasdaq Globe Newswire 20 Jan 2026
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Celcuity Presents Updated Results from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 Trial ...
Nasdaq Globe Newswire 11 Dec 2025
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Gedatolisib, a multitarget PI3K/AKT/mTOR inhibitor, plus fulvestrant with or without palbociclib for second-line treatment of patients with HR+/HER2-/ PIK3CA-WT advanced breast cancer: updated results from the randomized, phase 3 VIKTORIA-1 trial (Celcuity Inc)
Public Technologies 11 Dec 2025
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Celcuity to Present Updated Data from the PIK3CA Wild-Type Cohort of the Phase 3 VIKTORIA-1 ...
Nasdaq Globe Newswire 26 Nov 2025
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Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer (Form 8-K) (Celcuity Inc)
Public Technologies 17 Nov 2025
FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer ... The submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.
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