CELCUITY INC

At the Citigroup Biopharma Summit, Celcuity announced it will begin the commercial launch of REVTORPYK this quarter, deploying a 90-person oncology field force and 18 months of market access groundwork. The company is offering two approved regimens (doublet and triplet) and expects physicians to choose the triplet in most cases (estimated split 80/20). In parallel, Celcuity is pursuing approval filings for a PIK3CA subpopulation, expanding manufacturing capacity, and working on first-line programs, prostate cancer studies, and a subcutaneous formulation. » More on de.investing.com

At the Wells Fargo Healthcare Conference Celcuity presented the commercial launch of REVTORPYK (gedatolisib) for two approved second‑line regimens in metastatic breast cancer, citing strong efficacy data (hazard ratios 0.24 for the triplet and 0.33 for the doublet). The market launch is planned by the end of Q3 2024 but is conditional on approval of a second manufacturing site; supply security, reimbursement, and physician uptake are cited as critical success factors. Pricing was mentioned at roughly $30,000 per cycle, and the go‑to model will primarily be buy‑and‑bill. Celcuity also expects a decision on an add‑on approval for PIK3CA‑mutated patients in Q2 2025 and is developing a subcutaneous formulation for later indications. » More on de.investing.com