Precigen completes submission of bla with request for priority review to the fda for prgn-2012 for the treatment of adults with recurrent respiratory papillomatosis

–   prgn-2012 has the potential to be the first fda-approved therapeutic for the treatment of adults with rrp, a rare and devastating chronic disease for which the current standard-of-care is repeated surgeries – –   prgn-2012 received breakthrough therapy designation from the fda and orphan drug designation from the fda and the european commission – –   the bla, under an accelerated approval pathway, is supported by data from the phase 1/2 pivotal study in which more than 50% of patients achieved complete response and more than 85% of patients had a decrease in surgical interventions in the year after prgn-2012 treatment compared to the year prior to treatment –  –   prgn-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than grade 2 – germantown, md. , dec. 30, 2024 /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 completion of the rolling submission for a biologics license application (bla) to the us food and drug administration (fda) for prgn-2012 (inn: zopapogene imadenovec † ) for the treatment of adult patients with recurrent respiratory papillomatosis (rrp).
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