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Optinose - OPTN STOCK NEWS

Welcome to our dedicated page for Optinose news (Ticker: OPTN), a resource for investors and traders seeking the latest updates and insights on Optinose stock.

Optinose Inc (OPTN) is a specialty pharmaceutical innovator focused on chronic sinusitis treatments through its patented Exhalation Delivery System. This page provides investors and healthcare professionals with essential updates on regulatory developments, clinical research, and corporate milestones.

Track key developments including FDA decisions, peer-reviewed study publications, and partnership announcements. Our curated news collection helps stakeholders monitor progress in ENT-focused drug-device combinations and chronic disease management innovations.

Find verified updates on XHANCE clinical trials, financial earnings reports, and market expansion strategies. All content undergoes strict editorial review to ensure accuracy and relevance for investment research and therapeutic advancement tracking.

Bookmark this page for timely updates on Optinose's novel approaches to nasal drug delivery and specialty pharmaceutical developments. Regularly refreshed content supports informed decision-making for investors and healthcare analysts alike.

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Optinose (OPTN) receives FDA approval for XHANCE nasal spray to treat chronic rhinosinusitis without nasal polyps, marking a significant breakthrough in treating a debilitating condition affecting millions of adults in the U.S. The drug-device combination product demonstrated a statistically significant reduction in symptoms, sinus inflammation, and acute exacerbations in clinical trials. XHANCE uses a proprietary Exhalation Delivery System to target areas of inflammation deep in the nose. The approval is a crucial advancement in providing effective treatment options for patients suffering from chronic sinusitis.
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Optinose (OPTN) reports fourth quarter and full year 2023 financial results, with XHANCE net revenue of $19.9 million and $71.0 million. The company is awaiting FDA approval for XHANCE for chronic sinusitis treatment by March 16, 2024. Despite revenue decreases, operational efficiency improved, with a net loss of $10.0 million for Q4 2023 and $35.5 million for full year 2023. Cash and cash equivalents stand at $73.7 million as of December 31, 2023.
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Optinose (OPTN) will host a conference call on March 7, 2024, to discuss financial results for the fourth quarter of 2023 and corporate updates. Participants can join via webcast or telephone.
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Optinose (NASDAQ:OPTN) announced the peer-reviewed publication of results from two Phase 3 Clinical Trials evaluating XHANCE for the treatment of chronic sinusitis. The trials showed a significant reduction in symptoms and sinus opacification in patients with chronic rhinosinusitis. XHANCE is a drug-device combination product that uniquely combines a widely used nasal anti-inflammatory drug with an innovative delivery system designed to deliver the medication high and deep into difficult-to-access sinuses and sinonasal drainage tracts. The FDA Supplemental New Drug Application has been filed with a target goal date of March 16, 2024.
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Optinose (OPTN) announced that the FDA has extended the review period for its supplemental new drug application (sNDA) for XHANCE as a treatment for chronic rhinosinusitis, with the updated Prescription Drug User Fee Act (PDUFA) goal date set for March 16, 2024. The FDA requested additional efficacy subset analyses of existing clinical data, leading to the extension. XHANCE could potentially be the first and only drug indicated for the treatment of chronic rhinosinusitis, a diagnosis assigned at approximately 10 million patient visits annually.
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Optinose (OPTN) to present company overview and business update at 35th Annual Piper Sandler Healthcare Conference on November 29, 2023
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Optinose (NASDAQ:OPTN) reports Q3 2023 XHANCE net revenue of $19.8 million, expects net revenue for 2023 to be between $66.0 to $70.0 million. The company's operating efficiency improved as SG&A and R&D expenses decreased by 33%. PDUFA goal date for XHANCE Chronic Rhinosinusitis sNDA is December 16, 2023.
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Optinose to report Q3 2023 financial results and corporate updates on November 9, 2023.
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Optinose to present at Cantor Global Healthcare Conference
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Optinose

Nasdaq:OPTN

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92.87M
9.40M
7.17%
72.66%
2.42%
Drug Manufacturers - Specialty & Generic
Pharmaceutical Preparations
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United States
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