Shares of Precigen Inc. (PGEN) are up over 50% at $2.77 in premarket hours, on news of the company securing FDA approval for its drug, Papzimeos, for the treatment of adults with recurrent respiratory papillomatosis.
Recurrent Respiratory Papillomatosis (RRP) is a rare, non-cancerous viral tumor in the airways caused by the human papillomavirus (HPV) that can potentially be life-threatening. It is estimated that approximately 27,000 adult patients in the US and more than 125,000 patients outside of the US are affected by RRP.
There is no known cure for RRP, and the typical treatment involves frequent surgeries, which do not target the root cause of the disease and often lead to considerable complications. PAPZIMEOS becomes the first and only FDA-approved therapy for the treatment of adults with RRP.
PAPZIMEOS, formerly known as PRGN-2012, is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins -- the root cause of RRP.
The company submitted the Biologics License Application for PAPZIMEOS on a rolling basis, completing the submission in December 2024 under an accelerated approval pathway. Usually, the FDA requires confirmatory trials for a drug approved via the accelerated approval pathway. But in the case of PAPZIMEOS, full approval has been granted, which does not require a confirmatory clinical trial.
The promotion activities of PAPZIMEOS would be taken up immediately, revealed the company.
PGEN has traded in a range of $0.65 to $2.17 in the last 1 year. The stock closed yesterday's trading at $1.85, down 3.14%.
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