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FDA Calendar - Celcuity Inc.

Company Name Celcuity Inc.
CELC
Drug Name Gedatolisib (NDA)
Event Name FDA decision on gedatolisib in hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), PIK3CA wild-type advanced breast cancer
Event Date 07/17/2026
Outcome Date
Outcome Pending
Drug Status Priority Review
Rival Drugs
Market Potential
Other Approvals
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