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
Portfolio Pulse from
The FDA has granted Priority Review to Precigen's BLA for PRGN-2012, a gene therapy for recurrent respiratory papillomatosis (RRP). If approved, it would be the first FDA-approved therapy for RRP, with a target action date set for August 27, 2025.
February 25, 2025 | 1:30 pm
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Precigen's BLA for PRGN-2012 has been granted Priority Review by the FDA, potentially making it the first approved therapy for recurrent respiratory papillomatosis. This could significantly impact Precigen's market position and stock value.
The FDA's Priority Review designation indicates the potential for PRGN-2012 to significantly improve treatment for RRP, a serious condition. Approval would position Precigen as a leader in this niche market, likely boosting investor confidence and stock value.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100