FDA Approval of Papcemias
Papcemias received full FDA approval with a broad label for all adult RRP patients, marking it as the first and only treatment available for recurrent respiratory papillomatosis (RRP).
Papcemias Clinical Efficacy
51% of patients achieved complete response with no surgery required for twelve months post-treatment, and 86% had a reduction in surgical burden after treatment with Papcemias.
Rapid Commercial Deployment
The sales team was fully deployed, engaging 90% of target institutions quickly, and payer coverage advancing rapidly with over 80 million lives covered.
Strong Financial Position
Precigen expects its cash, investments, and projected revenues from Papcemias to fund operations to cash breakeven by 2026.
Manufacturing Capacity
Precigen has a dedicated in-house cGMP facility fully operational and successfully inspected by the FDA for Papcemias drug substance manufacturing.