07:35 AM EST, 12/30/2024 (MT Newswires) -- Precigen ( PGEN ) said Monday it has completed a rolling biologics license application submission to the US Food and Drug Administration for PRGN-2012, a treatment for recurrent respiratory papillomatosis in adults.
The FDA is reviewing the submission to determine acceptance and to set a Prescription Drug User Fee Act action date, the company said.
Precigen ( PGEN ) said it has requested a priority review, which would shorten the review period to six months, the company said.
Precigen ( PGEN ) shares were more than 18% higher in premarket trading.