Celcuity disclosed subgroup efficacy from its Phase 3 breast cancer program and said it plans to complete a new drug application by year-end after presenting positive data at ESMO. The biotech reported what it characterized as “paradigm-shifting” results in a molecularly defined cohort; those topline outcomes previously propelled the company’s stock and investor attention. Company executives outlined next steps for regulatory engagement and submission timelines at the conference. Celcuity’s readout underscores continued investor appetite for targeted therapies that claim clear predictive biomarkers and supports ongoing competition among small biotechs seeking label-expanding approvals. Regulatory reviewers will scrutinize the biomarker strategy, subgroup durability and safety profile as Celcuity prepares its dossier.