Posted by Michael Wonder on 25 Feb 2025
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 27 August 2025
25 February 2025 - If approved, PRGN-2012 would be the first and only available FDA approved therapy for eligible patients with RRP, a rare and devastating chronic disease for which the current standard-of-care is repeated surgeries.
Precigen today announced the US FDA has accepted the company's biologics license application for PRGN-2012 (zopapogene imadenovec), an investigational AdenoVerse gene therapy for the treatment of adults with recurrent respiratory papillomatosis.
