PRGN-2009

The FDA has accepted Precigen's Biologics License Application for PRGN-2012 with priority review, setting a PDUFA target action date of August 27, 2025 for the potential first-ever approved therapy for recurrent respiratory papillomatosis.

Precigen completed a pre-BLA meeting with the FDA, achieving full alignment on the BLA content for PRGN-2012, targeting a rolling submission in Q4 2024.

Precigen, Inc. reported its financial results for the second quarter and first half of 2024, highlighting significant advancements in its PRGN-2012 gene therapy for recurrent respiratory papillomatosis (RRP), strategic portfolio reprioritization, and financial maneuvers to strengthen its cash position.