Optinose falls as US FDA extends review of nasal spray

OptiNose

06/12/2023 14:02

** Shares of drug developer Optinose Inc  OPTN.O  fall 19%
to $1.19 premarket  
    ** OPTN says FDA has extended review of its supplemental
application requesting approval of drug-device combination,
Xhance, to treat chronic sinusitis
    ** FDA will finalize its decision by March 16, 2024 vs
previously given date of Dec. 16 - OPTN
    ** Says FDA had requested additional efficacy data from one
of the two trials submitted as part of the application 
    ** Chronic sinusitis is a condition in which cavities around
nasal passages are inflamed and swollen for at least 12 weeks,
for which there are currently no FDA-approved treatments
    ** Xhance is already approved in U.S. for treatment of nasal
polyps, a condition which causes swelling of the nasal lining
    ** Up to last close, stock down 20.5% YTD 

 (Reporting by Mariam Sunny in Bengaluru)
 ((Mariam.ESunny@thomsonreuters.com;))