The Bad News: OPTN shares took a nosedive after OptiNose, Inc. 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 now 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.
The Ugly Details:OptiNose submitted additional efficacy subset analyses of existing clinical data from one of the two trials submitted in the sNDA: ReOpen1, as requested, on November 22, 2023, after an earlier prompt by the FDA on November 15, 2023. However, on December 4, 2023, the FDA notified OptiNose that it would need more time to review the submission.
The CEO, Ramy Mahmoud, MD, MPH, expressed his frustration, stating, “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.”
The Fallout: OPTN shares plummeted by 19.73% to $1.18 premarket on the last check Wednesday.
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