Posted by Michael Wonder on 31 Dec 2024
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
30 December 2024 - 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.
Precigen today announced the completion of the rolling submission for a biologics license application to the US FDA for PRGN-2012 (zopapogene imadenovec) for the treatment of adult patients with recurrent respiratory papillomatosis.
