Celcuity Submits Breast Cancer Drug to FDA After 1,000% Stock Rally
Company's lead drug, Gedatolisib, moves to regulatory review for treating advanced HR+/HER2- breast cancer, a multi-billion dollar market.
Celcuity Inc. has completed the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration for its lead drug candidate, Gedatolisib, marking a critical milestone for the clinical-stage biotechnology firm.
The application seeks approval for the drug as a treatment for patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer. This pivotal step moves Celcuity closer to potentially commercializing its first product in a highly competitive and lucrative oncology market.
Despite the significance of the regulatory filing, shares of Celcuity (NASDAQ: CELC) were muted in recent trading, closing at $89.64. The reaction reflects a stock that has already experienced a monumental run-up of over 1,000% from its 52-week low of $7.58, pushing its market capitalization to approximately $3.9 billion before it has generated any revenue.
A New Therapeutic Approach
Gedatolisib is a novel, potent inhibitor of cellular pathways known as PI3K and mTOR, which are critical for cancer cell growth and survival. The NDA submission is supported by compelling results from the company's Phase 3 VIKTORIA-1 clinical trial. According to the company's press release dated November 17, 2025, the study demonstrated that Gedatolisib in combination with other therapies led to a statistically significant improvement in progression-free survival.
Data from the trial showed a 76% reduction in the risk of disease progression or death for patients treated with the Gedatolisib-based regimen compared to a standard treatment. This strong clinical profile has garnered both Breakthrough Therapy and Fast Track designations from the FDA, potentially expediting the review process.
Market Potential and Analyst Perspectives
The target indication, HR+/HER2- breast cancer, is the most common subtype of the disease, and analysts project a significant commercial opportunity for an effective new therapy. Some market analyses project peak annual revenues for Gedatolisib could reach between $2.5 billion and $3 billion, should it gain FDA approval and achieve widespread adoption.
Wall Street's reaction to Celcuity's progress has been mixed, largely due to valuation concerns. While firms like Stifel have raised their price targets to as high as $115 following positive clinical data, others have adopted a more cautious stance. Analysts at H.C. Wainwright recently downgraded the stock to Neutral, suggesting the company's current valuation may be "priced for perfection" and already reflects a successful launch. The consensus analyst price target currently stands at $97.25.
Brian Sullivan, CEO of Celcuity, expressed confidence in the submission, stating, "The completion of our NDA submission for gedatolisib is a momentous achievement for our team and a critical step forward for patients with HR+/HER2- advanced breast cancer. We believe gedatolisib, if approved, could become a new standard of care."
The Path Forward
With the application now submitted, the FDA has 60 days to formally accept the NDA for review. If accepted, the agency will set a target action date under the Prescription Drug User Fee Act (PDUFA), which is typically 8 to 10 months from the submission date. Given the drug's Fast Track status, the review could be completed on an accelerated timeline.
For Celcuity, the focus now shifts from clinical development to regulatory review and pre-commercialization activities. The coming months will be crucial as investors watch for the FDA's acceptance of the application and the subsequent setting of a PDUFA date, which will serve as the next major catalyst for the company.