Precigen (PGEN) has finalized the rolling submission of a Biologics License Application (BLA) to the FDA for PRGN-2012, aimed at treating adult patients with recurrent respiratory papillomatosis. This submission is currently within the FDA's initial 60-day review phase, during which the agency will determine whether to accept the BLA for full evaluation and establish the PDUFA action date. The application also requests priority review status.
Helen Sabzevari, the CEO of Precigen, commented, "Following our recently announced financial transactions, which strengthen our balance sheet, we have secured our financial runway through 2026. This positions us well for a potential commercial launch in the latter half of 2025."
PRGN-2012 is an investigational AdenoVerse gene therapy, aiming to induce immune responses against cells infected with human papillomavirus strains HPV 6 or HPV 11.
