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 august 27, 2025

– priority review reduces the bla review timeline to 6-months and is granted to therapies that, if approved, would provide significant improvements in the treatment, diagnosis or prevention of serious conditions – – 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 – germantown, md. , feb. 25, 2025 /prnewswire/ -- precigen, inc. (nasdaq: pgen), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced the us food and drug administration (fda) has accepted the company's biologics license application (bla) for prgn-2012 (nonproprietary name: zopapogene imadenovec † ), an investigational adenoverse ® gene therapy for the treatment of adults with recurrent respiratory papillomatosis (rrp).
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