Celcuity Inc. filed a new drug application (NDA) for its PI3K/mTOR inhibitor gedatolisib in hormone‑receptor positive, HER2‑negative advanced breast cancer on November 17, 2025. The submission was made under the FDA’s Real‑Time Oncology Review (RTOR) program, which allows the agency to review oncology data in near real‑time and can accelerate the approval process.
The NDA is supported by the Phase 3 VIKTORIA‑1 trial, which enrolled patients with wild‑type PIK3CA status. In the triplet arm that combined gedatolisib with fulvestrant and palbociclib, the hazard ratio for progression or death was 0.24, translating to a 76 % risk reduction and a median progression‑free survival (PFS) of 9.3 months versus 2.0 months for fulvestrant alone. The doublet arm with gedatolisib and fulvestrant achieved a 67 % risk reduction (hazard ratio 0.33) and a median PFS of 7.4 months, underscoring the drug’s potency in a population that has limited therapeutic options.
The submission positions Celcuity to move toward commercialization of its lead asset and to potentially file its first FDA approval. The company’s cash balance of roughly $455 million as of the third quarter of 2025 is projected to fund operations through 2027, giving it a runway to support clinical development, regulatory strategy, and eventual launch activities. The company also maintains a robust intellectual‑property portfolio that protects gedatolisib until 2042, providing a long‑term competitive moat.
Analysts have responded to the NDA filing with a mix of optimism and caution. Several firms upgraded their outlooks on the company, citing the strong efficacy data and the favorable market opportunity in the PIK3CA wild‑type patient subset, which is estimated to represent a $5 billion to $6 billion addressable market. At the same time, some analysts have downgraded the company or adjusted their price targets, reflecting concerns about valuation multiples and the uncertainty of the regulatory review timeline.
CEO Brian Sullivan said the NDA submission is a “critical milestone” that brings gedatolisib one step closer to patient access. He emphasized confidence in the drug’s safety profile and the company’s ability to navigate the FDA’s review process, noting that the RTOR pathway could shorten the time to approval.
Celcuity plans to continue engaging with the FDA under the RTOR framework, with the goal of receiving a decision in the first half of 2026. The company will also advance its VIKTORIA‑2 Phase 3 trial in the first‑line setting and pursue additional studies to expand gedatolisib’s therapeutic indications. Successful regulatory approval would unlock significant commercial potential and could transform Celcuity’s financial trajectory.
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