Celcuity Advances Cancer Drug Application with FDA Review Program

Celcuity (CELC) has received FDA review program approval for its new drug application for gedatolisib, a treatment for HR+/HER2- advanced breast cancer. The application is part of the Real-Time Oncology Review program, allowing for earlier submission of efficacy and safety data. The company plans to commence a progressive submission of its NDA in September, aiming to complete the submission by Q4 2025. Celcuity is a clinical-stage biotechnology company with a market capitalization of approximately $2.12 billion.

Minneapolis, Aug. 27, 2025 — Celcuity Inc. (NASDAQ: CELC), a clinical-stage biotechnology company, has received FDA approval to review its New Drug Application (NDA) for gedatolisib under the Real-Time Oncology Review (RTOR) program. The company plans to initiate a progressive submission of its NDA in September 2025, targeting completion by the fourth quarter of 2025.

Gedatolisib, a potent inhibitor of the PI3K and mTORC1/2 pathways, demonstrated remarkable efficacy in the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer. The trial showed that the gedatolisib-triplet therapy (gedatolisib, fulvestrant, and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant alone, with a median progression-free survival (PFS) of 9.3 months versus 2.0 months. The gedatolisib-doublet (gedatolisib and fulvestrant) showed a 67% risk reduction and a median PFS of 7.4 months.

The RTOR program allows for the earlier submission of efficacy and safety data, potentially expediting the review process and bringing the drug to market sooner. Celcuity's NDA submission is based on the topline results from the PIK3CA wild-type cohort of the VIKTORIA-1 trial, which demonstrated unprecedented efficacy in HR+/HER2- advanced breast cancer.

Celcuity's market capitalization is approximately $2.12 billion, reflecting the company's significant investment in targeted therapies for oncology. The company's lead therapeutic candidate, gedatolisib, has received both Breakthrough Therapy and Fast Track designations, underscoring its potential significance in treating HR+/HER2- advanced breast cancer.

References:
[1] https://www.stocktitan.net/news/CELC/celcuity-to-initiate-nda-submission-of-gedatolisib-in-pik3ca-wild-u9uvrrmp5z07.html
[2] https://www.morningstar.com/news/globe-newswire/9519366/celcuity-to-initiate-nda-submission-of-gedatolisib-in-pik3ca-wild-type-cohort-in-hrher2-advanced-breast-cancer-under-fdas-real-time-oncology-review-program