Pfizer sold gedatolisib to Celcuity for $10 million upfront in 2021. That investment just paid off: the pan-PI3K/mTOR inhibitor beat Novartis’ Piqray in the Viktoria-1 phase 3 trial, sending Celcuity shares up about 15% to $144 in premarket trading.
The trial tested gedatolisib in PIK3CA-mutant breast cancer. Progression-free survival was significantly longer in patients who received gedatolisib, AstraZeneca’s Faslodex, and Pfizer’s Ibrance than in those on Piqray-Faslodex. A secondary endpoint comparing gedatolisib-Faslodex against Piqray-Faslodex also cleared.
Celcuity’s already got one FDA application pending: a ruling on gedatolisib in PIK3CA-wild-type breast cancer is due July 17. The company now plans to file a supplemental new drug application covering PIK3CA-mutant patients.
Evaluate included gedatolisib in its top 10 drug launches for 2026, forecasting $2.1 billion in sales by 2032. Pfizer terminated a separate PI3K/mTOR program over tolerability; Eli Lilly dropped its own after clinical data came in.
Tolerability is still in focus. Gedatolisib’s hyperglycemia rates ran lower than Piqray’s, which Novartis linked to grade 3 cases in one-third of patients during development. TD Cowen analysts flagged “high rates” of stomatitis as a concern in December.
Full data, including PFS magnitude and the safety profile, won’t be public until ASCO’s Annual Meeting in late May and early June. The presentation was a late-breaking addition — posted by ASCO on Friday, possibly after the original abstract deadline. Leerink Partners analysts said the timing suggests an outsized PFS benefit. Celcuity plans to seek European approval in the fourth quarter.
— Sarah Chen