OptiNose, Inc. OPTN shares are trading lower after the company announced a three-month extension of the FDA review period for the supplemental new drug application for XHANCE as a treatment for chronic rhinosinusitis.
The updated Prescription Drug User Fee Act (PDUFA) goal date is March 16, 2024.
XHANCE (fluticasone propionate) nasal spray is a drug-device combination product that combines the most widely used nasal anti-inflammatory drug with the innovative Exhalation Delivery System.
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On November 15, 2023, as part of the ongoing sNDA review, the FDA requested that Optinose submit additional efficacy subset analyses of existing clinical data from one of the two trials submitted in the sNDA: ReOpen1. Optinose presented the requested analyses on November 22, 2023.
But on December 4, 2023, the FDA notified Optinose that it would require additional time to review this submission.
"We believe the ReOpen trials demonstrated important clinical benefits XHANCE could offer chronic sinusitis patients and, if approved, we look forward to providing doctors and their patients the first-ever medication to treat all chronic sinusitis patients, including those with or without nasal polyps," stated Ramy Mahmoud, MD, MPH, CEO of Optinose.
Price Action: OPTN shares are trading lower by 19.73% to $1.18 premarket on the last check Wednesday.
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