Celcuity’s Gedatolisib: A Promising Standard for 2L Breast Cancer Treatment

TD Cowen analyst Tara Bancroft has maintained their bullish stance on CELC stock, giving a Buy rating on November 10.

Tara Bancroft’s rating is based on several compelling factors surrounding Celcuity’s recent developments and data. The presentation of full PIK3CA WT data at ESMO has reinforced confidence in the efficacy of gedatolisib, particularly in the 2L breast cancer setting. The data suggest a significant improvement in median progression-free survival (mPFS) compared to standard care, which positions gedatolisib as a potentially superior treatment option. This efficacy, combined with the FDA’s positive interim overall survival analysis, underscores the drug’s potential to become a standard therapy for 2L patients.
Additionally, the company’s selection for the Real-Time Oncology Review (RTOR) pilot highlights the quality and potential impact of its data. The ongoing rolling submissions for the NDA, expected to be completed in Q4, and the anticipated mid-2026 approval further support the Buy rating. The strategic timing of submissions aims to streamline the approval process, allowing for a swift introduction to the market. These factors collectively indicate a promising outlook for Celcuity, justifying the Buy recommendation.