OPTINOSE, INC. By Colin Kellaher
Shares of Optinose plunge in premarket trading Wednesday after the pharmaceutical company said the U.S. Food and Drug Administration has extended the review of a request for expanded approval of its Xhance nasal spray by three months.
Optinose, which is seeking approval of Xhance as a treatment for chronic rhinosinusitis, said the FDA needs more time to review additional efficacy subset analyses the Yardley, Pa., company recently submitted at the agency's request.
Optinose said the FDA extended its target action date on the application to March 16, 2024.
Optinose shares, which closed Tuesday at $1.47, were recently down 22% to $1.14 in premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
12-06-23 0833ET
