Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that REVTORPYK™ (gedatolisib) is now commercially available in the United States for eligible patients with hormone receptor-positive ("HR+"), human epidermal growth factor receptor 2-negative ("HER2-"), locally advanced or metastatic breast cancer ("ABC") without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK was approved in combination with palbociclib and fulvestrant ("REVTORPYK triplet") and in combination with fulvestrant ("REVTORPYK doublet"), by the U.S. Food and Drug Administration ("FDA") on July 14, 2026.

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