Clinical Trial SuccessThe key result was a 9.3 month median progression-free survival from the gedatolisib + fulvestrant + palbociclib triplet, versus 2.0 months for the fulvestrant monotherapy comparator arm.
Financial PerformanceThe latest amendment increases the total term loan facility size up to $500 million, significantly enhancing the company's financial strength.
Regulatory MilestonesThe FDA agreed to accept the NDA for Celcuity's pan-PI3K/mTOR inhibitor, gedatolisib, under the agency's Real-Time Oncology Review program.