Precigen (PGEN) announced the completion of the rolling submission for a biologics license application to the FDA for PRGN-2012 for the treatment of adult patients with recurrent respiratory papillomatosis. The submission is in the initial 60 day review period, during which time the FDA will decide whether to accept the BLA for further review and set the PDUFA action date. The BLA included a request for priority review.
Helen Sabzevari, CEO of Precigen, said: "With our most recent financial transactions announced last week to enhance our balance sheet, we have extended our cash runway into 2026, well beyond potential commercial launch in the second half of 2025."
PRGN-2012 is an investigational AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus 6 or HPV 11.
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