Celcuity Inc. (CELC)’s FDA NDA for Gedatolisib Accepted Under RTOR, Accelerating Review

We recently compiled a list of the 12 Best Performing Healthcare Stocks to Buy Right Now. Celcuity Inc. is one of them.

Celcuity Inc. (NASDAQ:CELC) is a clinical-stage biotechnology company developing targeted oncology therapies, with a focus on solid tumors such as advanced breast cancer. Its lead drug candidate, gedatolisib, targets the PI3K and mTOR pathways, key drivers of tumor growth and resistance, aiming to improve outcomes for patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer. CELC stands twelfth on our list among the best performing stocks.

In August 2025, the U.S. FDA accepted CELC’s New Drug Application (NDA) for gedatolisib under the Real-Time Oncology Review (RTOR) program, allowing for a faster and more efficient regulatory process. The firm began its rolling submission in September and expects to complete it in the fourth quarter of 2025. This milestone follows strong Phase 3 VIKTORIA-1 trial results, which showed that gedatolisib significantly reduced disease progression risk and improved progression-free survival in the PIK3CA wild-type cohort. The therapy also holds Breakthrough Therapy and Fast Track designations, highlighting its potential to address unmet needs in patients who no longer respond to CDK4/6 inhibitors.

To support its late-stage development and prepare for commercialization, Celcuity Inc. (NASDAQ:CELC) recently expanded its senior secured credit facility to $500 million. The additional capital strengthens the company’s financial position, reduces liquidity concerns, and ensures resources are in place as it advances toward potential FDA approval and market launch.

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