Clinical Trial SuccessCelcuity reported positive topline results from the PIK3CA WT portion of the Phase 3 VIKTORIA-1 trial testing their pan-PI3K/mTOR inhibitor, gedatolisib, for ER+ breast cancer patients.
Financial FlexibilityThe latest amendment increases the total term loan facility size up to $500 million, significantly enhancing the company's financial strength.
Regulatory ProgressThe FDA agreed to accept the NDA for Celcuity's pan-PI3K/mTOR inhibitor, gedatolisib, under the agency's Real-Time Oncology Review program.