Celcuity posts $73.3m quarterly loss as breast cancer drug reaches market

Celcuity reported a third-quarter 2026 net loss of $73.3 million on 5 November. The result covers a period in which the company's first medicine, REVTORPYK (gedatolisib), was approved but had barely reached the market, so the income statement shows costs without any sales to offset them.

The US Food and Drug Administration cleared the drug on 14 July 2026 for advanced breast cancer that is hormone receptor-positive and HER2-negative, lacks a PIK3CA mutation, and has already been treated with endocrine therapy. Product did not ship until 30 September, the final day of the quarter, about eleven weeks after approval. Celcuity booked no sales for the period.

On access, the company says payers covering about 91% of insured US lives, across commercial plans and Medicare, now cover the drug. The information available does not say what conditions come with that coverage, such as prior authorisation or step therapy, so the figure indicates breadth of listing rather than ease of prescribing.

Celcuity also filed a supplemental new drug application for patients whose tumours carry a PIK3CA mutation. This is the standard US route for adding a population to an approved drug's label. No FDA decision date has been disclosed. At the ESMO congress, the company presented updated data from its VIKTORIA-1 trial, plus results in prostate cancer.