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 said it has requested a priority review, which would shorten the review period to six months, the company said.
Precigen shares were more than 18% higher in premarket trading.
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