Why ENT-Focused OptiNose Shares Are Diving Today
Portfolio Pulse from Nabaparna Bhattacharya
OptiNose, Inc. (NASDAQ:OPTN) stock plummeted after announcing a three-month delay in the FDA review of XHANCE for chronic rhinosinusitis. The new PDUFA goal date is March 16, 2024. The FDA requested additional analyses of clinical data, which OptiNose submitted, but the FDA needs more time to review. OPTN shares dropped 19.73% to $1.18 in premarket trading.

December 06, 2023 | 2:21 pm
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NEGATIVE IMPACT
OptiNose shares fell sharply due to the FDA's extension of the review period for XHANCE, potentially delaying its market entry.
The FDA's request for additional time to review the supplemental new drug application for XHANCE directly impacts OptiNose's potential revenue and market position for this treatment. The delay is likely to be viewed negatively by investors, as it postpones the potential approval and commercialization of the drug, which is critical for the company's growth prospects. The significant premarket stock price drop reflects investor concerns over the delayed timeline.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100