Celcuity Phase 3 VIKTORIA-1 PIK3CA wild-type: gedatolisib triplet cuts progression/death risk by 76% (HR 0.24)

Celcuity Inc.

Gedatolisib triplet (plus palbociclib/fulvestrant) mPFS 9.3 mo vs 2.0 mo for fulvestrant, incremental gain 7.3 mo.
Gedatolisib doublet (plus fulvestrant) mPFS 7.4 mo vs 2.0 mo, reducing risk by 67% (HR 0.33; p<0.0001).
Treatment discontinuation due to AEs lower than prior Phase 1b; fewer hyperglycemia/stomatitis events.
Celcuity expects to submit NDA to FDA for gedatolisib in Q4 2025; mutation cohort topline by end of 2025.
Efficacy milestones: best HR and mPFS improvement ever reported in any Phase 3 for HR+/HER2- ABC.

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