FDA Grants Priority Review to Precigen's BLA for PRGN-2012 for the Treatment of Adults with Recurrent Respiratory Papillomatosis with PDUFA Target Action Date Set for August 27, 2025

Core Insights - The FDA has accepted Precigen's biologics license application (BLA) for PRGN-2012, a gene therapy for recurrent respiratory papillomatosis (RRP), with a priority review timeline of 6 months and a target action date of August 27, 2025 [1][5] - If approved, PRGN-2012 would be the first FDA-approved therapy for RRP, a rare disease currently managed through repeated surgeries [3][5] - The therapy aims to elicit immune responses against HPV 6 and HPV 11, which are responsible for RRP [2][3] Company Overview - Precigen, Inc. is a biopharmaceutical company focused on innovative gene and cell therapies, with a commitment to addressing serious medical conditions [1][7] - The company utilizes its AdenoVerse platform for gene delivery, which is designed to enhance immune responses and treat complex diseases [6][7] Clinical Study Results - The pivotal Phase 1/2 clinical study for PRGN-2012 demonstrated that over 50% of patients achieved a Complete Response, and more than 85% experienced a reduction in surgical interventions in the year following treatment [4] - The therapy was well-tolerated, with no dose-limiting toxicities or treatment-related adverse events greater than Grade 2 [4] Market Need - RRP is a chronic disease with no current cure, leading to a high unmet need for effective therapeutic alternatives [3][5] - The patient population in the U.S. is estimated to exceed 27,000 adults, highlighting the potential market for PRGN-2012 if approved [5]