Shares of Precigen Inc. (PGEN) have been on a tear since last August, fueled by a regulatory breakthrough for its lead drug, PAPZIMEOS.
On Aug.15, 2025, PAPZIMEOS received full approval from the FDA for the treatment of adults with recurrent respiratory papillomatosis (RRP). Although its Biologics License Application was under review via the accelerated approval pathway, the agency granted full approval - thereby eliminating the need for a confirmatory clinical trial.
Subscribe to continue reading the article.
This article is part of our premium content offering.Subscribe with a RTTNews subscription.
Subscribe NowAlready subscribed? Sign in
For comments and feedback: editorial@rttnews.com