Celcuity获得FDA乳腺癌治疗优先审查

2026-01-20 23:54

Celcuity (CELC) announced on Tuesday that the U.S. Food and Drug Administration (FDA) has granted priority review in connection with its New Drug Application for its lead asset, gedatolisib, targeted at a specific type of breast cancer.
The FDA has assigned July 17, 2026, as the target action date for the NDA, the Minneapolis, Minnesota-based biotech said.
Specifically, the marketing application seeks FDA approval of gedatolisib for hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA wild-type advanced breast cancer.
The NDA is supported by data from the company’s Phase 3 VIKTORIA-1 clinical trial in which gedatolisib, as part of a combination therapy, indicated a median progression-free survival of up to 12.4 months with a favorable safety profile, according to a data update last month.

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