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Precigen Completes Submission of Biologics License Application for Respiratory Disease Treatment; Shares Jump Pre-Bell
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Precigen Completes Submission of Biologics License Application for Respiratory Disease Treatment; Shares Jump Pre-Bell
Dec 30, 2024 5:06 AM

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.

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