Precigen shares rise 7.37% in premarket after FDA sets priority review date for PRGN-2012.

Precigen, Inc. surged 7.37% in premarket trading, after the U.S. FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, for the Biologics License Application (BLA) of PRGN-2012. The company reported a 51% complete response rate and 86% reduction in surgical intervention in Phase 1/2 trial NCT04724980. Precigen focuses on developing next-generation gene and cell therapies, with core areas including immuno-oncology, autoimmune diseases, and infectious diseases.