Commercial StrategyThe company is working with Eversana, an expert in commercialization of rare disease therapies, to enter the market successfully.
Product EfficacyIn the pivotal Phase 1/2 trial, PRGN-2012 demonstrated that more than 50% of patients achieved a complete response and more than 85% of patients experienced a decrease in surgical interventions.
Regulatory ApprovalThe FDA has accepted the BLA for PRGN-2012 as a treatment for recurrent respiratory papillomatosis (RRP) and set a PDUFA date, indicating a smooth approval process.