Celcuity Inc. (CELC) announced the completion of its New Drug Application submission to the FDA for gedatolisib in patients with HR+/HER2-/PIK3CA wild-type breast cancer.
The New Drug Application (NDA) was submitted under the FDA's Real-Time Oncology Review (RTOR) program, designed to facilitate shorter regulatory review periods.
Gedatolisib has previously received both Breakthrough Therapy and Fast Track designations.
In a phase 3 trial, dubbed VIKTORIA-1, Gedatolisib was evaluated in combination regimens in patients with advanced breast cancer. The study includes both PIK3CA wild-type and mutant cohorts.
Results from the PIK3CA wild-type cohort demonstrated significant efficacy, as shown below:
-- The gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant alone, with median progression-free survival (PFS) of 9.3 months vs 2 months.
-- The gedatolisib doublet (gedatolisib + fulvestrant) reduced the risk of progression or death by 67%, with median PFS of 7.4 months vs 2 months.
Gedatolisib is a multi-targeted PI3K/AKT/mTOR ("PAM") inhibitor, designed to comprehensively block the PAM pathway by targeting all four Class I PI3K isoforms, mTORC1, and mTORC2.
Unlike single-target inhibitors, gedatolisib minimises adaptive cross-activation, enabling full suppression of the pathway. Preclinical and early clinical data have shown comparable potency in both PIK3CA-mutant and wild-type breast tumor cells.
Celcuity's CEO Brian Sullivan called the NDA submission "an important milestone", noting that the efficacy and safety profile of gedatolisib regimens are "potentially practice-changing" for patients with HR+/HER2- advanced breast cancer.
Celcuity has completed enrollment for PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial and expects topline data to be available in late Q1 2026 or Q2 2026.
VIKTORIA-2, a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line therapy, is enrolling patients.
CELC-G-201, a Phase 1/2 trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC), is ongoing.
CELC has traded in the range of $7.57 to $96.07 over the past year. The stock closed yesterday's trading at $92.23, down 0.49%.
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