Celcuity Inc. (NASDAQ: CELC) announced on November 19, 2025 that it has completed the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration for its lead candidate, gedatolisib, in hormone‑receptor positive (HR+), HER2‑negative advanced breast cancer. The submission was formally filed on November 17, 2025 and was submitted under the FDA’s Real‑Time Oncology Review (RTOR) program, a pathway that can accelerate review for oncology products demonstrating substantial clinical benefit.
The NDA is built on the robust results from the Phase 3 VIKTORIA‑1 trial. In the PIK3CA wild‑type cohort, the gedatolisib‑triplet regimen reduced the risk of disease progression or death by 76% versus fulvestrant alone, and median progression‑free survival (PFS) increased from 2.0 to 9.3 months. The doublet regimen also showed a 67% risk reduction and a median PFS of 7.4 months compared with 2.0 months for fulvestrant alone. These data demonstrate a dramatic improvement in clinical outcomes for a population with limited treatment options.
Celcuity’s submission comes after the company received FDA Breakthrough Therapy and Fast Track designations for gedatolisib, underscoring the drug’s early promise and the potential for expedited regulatory review. The RTOR filing further signals the FDA’s willingness to prioritize the review of this therapy, which could shorten the time to market if the data are accepted.
The market opportunity for gedatolisib is substantial. Celcuity estimates a second‑line addressable market of $5 billion to $6 billion and projects peak revenues of $2.5 billion to $3 billion. Approval would position the company to capture a significant share of the advanced breast cancer treatment landscape, where current therapies are costly and often limited by resistance.
Financially, Celcuity remains a pre‑revenue company but has strengthened its balance sheet through recent financing. In Q3 2025 the company reported a net loss of $43.8 million, up from $29.8 million in Q3 2024, while maintaining a robust cash position that supports ongoing development and potential commercialization activities.
CEO Brian Sullivan emphasized the significance of the milestone, noting that the NDA submission brings gedatolisib “one step closer to availability for patients” and highlighted the drug’s “unprecedented efficacy and safety profile” for this class of pan‑PI3K/mTOR inhibitors. He added that the company is preparing for a potential launch and is confident in its ability to meet the unmet needs of patients with HR+/HER2‑negative advanced breast cancer.
The completion of the FDA NDA submission marks a pivotal step in Celcuity’s development program, moving gedatolisib closer to regulatory approval and the possibility of delivering a transformative therapy to patients who currently have limited options. The strong clinical data, combined with the company’s financial readiness and the sizable market opportunity, underscore the potential impact of this advancement on both the oncology treatment landscape and Celcuity’s future growth prospects.
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