By Colin Kellaher
Precigen has won U.S. Food and Drug Administration priority review for its application seeking approval of its proposed PRGN-2012 gene therapy for adults with recurrent respiratory papillomatosis, a rare disorder of the vocal cords.
Precigen on Tuesday said a green light would make PRGN-2012 the only FDA-approved therapeutic for the treatment of adults with the disorder, which is a lifelong neoplastic disease of the upper and lower respiratory tracts caused by infection with HPV 6 or HPV 11 that can be fatal.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Precigen said the FDA set a target action date of Aug. 27, adding that the agency indicated that is isn't currently planning to hold an advisory committee meeting to discuss the application.
The Germantown, Md., biopharmaceutical company said it hopes to introduce PRGN-2012 to the recurrent respiratory papillomatosis patient population, estimated at more than 27,000 adults in the U.S., later this year.
Precigen shares were recently up 5.2% to $1.84 in premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 25, 2025 08:28 ET (13:28 GMT)
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