Celcuity eyes a $10B breakthrough with gedatolisib in breast cancer

Celcuity reports phase 3 VIKTORIA-1 showing gedatolisib, a PAM pathway inhibitor, doubling median progression-free survival when combined with fulvestrant in PIK3CA-mutant HR+/HER2− metastatic breast cancer vs the PI3K inhibitor Piqray; the doublet achieved 11.3 months PFS vs 5.6 months, with the triplet (including Ibrance) at 11.1 months and higher objective response rates (35.7% and 48.9%). Analysts had expected around 12–14 months PFS. Celcuity touts a favorable safety profile and IV dosing three times monthly as advantages; FDA decision for non-mutant population expected by July 17, with an sNDA to follow in Q3. If frontline trials confirm benefit, the CEO believes gedatolisib could drive the company toward a $10B valuation.