As previously presented, gedatolisib + palbociclib + fulvestrant (“gedatolisib triplet”) and gedatolisib + fulvestrant (“gedatolisib doublet”) reduced the risk of disease progression or death versus ...
The U.S. Food and Drug Administration (“FDA”) accepted Celcuity’s New Drug Application (“NDA”) and granted Priority Review with a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026, f ...
MINNEAPOLIS, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced detailed efficacy ...
Clinically meaningful activity was observed in 57 patients at 400 mg BID fed, including 11.1-month median PFS and mutation-subtype–agnostic benefit across kinase versus nonkinase PIK3CA variants.
Celcuity highlighted strong phase III second-line data for gedatolisib in PIK3CA "wild-type" HR-positive breast cancer — the ...
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