Precigen Urges Priority Review for Treatment of 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

https://www.prnewswire.com/news-releases/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-302340014.html