Celcuity Inc. announced groundbreaking Phase III trial results for gedatolisib in HR-positive, HER2-negative advanced breast cancer, showing unprecedented hazard ratios and median progression-free survival (PFS) improvements, which could establish a new standard of care.

The trial demonstrated a median PFS of 9.3 months for gedatolisib combined with other therapies, compared to just 2 months for fulvestrant, with a hazard ratio of 0.24, indicating a significantly higher likelihood of disease control.

Management highlighted these hazard ratios as the most favorable ever reported in any Phase III trial across all therapy lines for this patient group, surpassing existing treatments.

Celcuity plans to submit a New Drug Application (NDA) to the FDA in late 2025 based on the positive data, with full dataset presentation scheduled for later this year.

The company’s ongoing clinical trial enrollment continues, with topline data from the PIK3CA mutant cohort expected by the end of 2025.

Safety profiles for gedatolisib regimens are favorable, showing lower rates of adverse events like hyperglycemia and stomatitis compared to earlier studies, supporting its clinical potential.

Celcuity’s strategic partnership with Pfizer grants global development rights and potential milestone payments up to $335 million, with patent protection extending into 2042.

Financially, Celcuity raised over $286 million through various offerings, bringing total cash, equivalents, and investments to $455 million, sufficient to fund operations through 2027.

Despite increased expenses and no current revenue, the company ended Q2 2025 with a cash position of approximately $168.4 million, supporting ongoing development and commercialization efforts.

Celcuity is actively expanding its pipeline, including trials in prostate cancer and other tumor types, aiming to broaden its therapeutic portfolio.

Management emphasized upcoming regulatory milestones and clinical data readouts as critical inflection points for transitioning from research to potential commercialization.

The company estimates a $5 billion addressable market for second-line therapy in this patient group, with plans to launch post-FDA approval.