Cure Today

Gedatolisib Triplet Boosts Progression-Free Survival in Breast Cancer

Gedatolisib, Faslodex, and Ibrance combination significantly improved progression-free survival in advanced breast cancer patients, reducing disease progression risk by 76%. The triplet regimen ...

Celcuity: Approaching An Inflection Point With Gedatolisib

Celcuity (CELC) stock: gedatolisib Phase 3 VIKTORIA-1 PFS gains in HR+/HER2- breast cancer, runway to 2027 and valuation ...

Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients

(Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced updates to the Phase 3 ...
Yahoo Finance

Celcuity Highlights Gedatolisib Breast Cancer Data, Near-Term Mutant Readout at Leerink Conference

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Targeted Oncology

VIKTORIA-2 Trial Evolves to Evaluate Gedatolisib in Endocrine-Sensitive and -Resistant Breast Cancer

Significant protocol amendments have been made to the ongoing phase 3 VIKTORIA-2 clinical trial (NCT06757634).The study, ...
Nasdaq

Celcuity presents overall survival data from Phase 1b trial with gedatolisib

Celcuity (CELC) announced overall survival, OS, data from two patient cohorts evaluated in a Phase 1b trial with gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in combination with palbociclib and either ...
Yahoo Finance

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

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Celcuity outlines VIKTORIA-2 expansion while targeting July 17 FDA decision for gedatolisib

Q1 2026 Management View CEO Brian Sullivan said, "We continue to make great progress as we prepare for the potential approval and commercial launch of gedatolisib in the third quarter," and added that ...
Nasdaq

Celcuity Stock Hits All-Time High On Gedatolisib Progress

(RTTNews) - Shares of Celcuity Inc. (CELC) touched an all-time high of $53.85 in early trading today, building on several eventful months driven by developments surrounding its lead drug candidate, ...
Seeking Alpha

Celcuity outlines $2.5B–$3B peak revenue potential for gedatolisib amid accelerated launch preparations

The company expects top line data from the PIK3CA mutant cohort of the VIKTORIA-1 trial in late Q1 or Q2 2026. Sullivan stated, "We expect to complete the submission [to FDA] this quarter." The ...
ascopubs.org

VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor–Positive/HER2−/PIK3CA Wild-Type Advanced Breast Cancer

Pembrolizumab With or Without Lenvatinib as First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Phase III LEAP-010 Study This phase III randomized trial (VIKTORIA-1; ...