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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.
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Optinose (NASDAQ:OPTN) announced the submission of a supplemental new drug application (sNDA) to the FDA for XHANCE, requesting approval for treating chronic rhinosinusitis. This application is based on Phase 3 clinical trial data from the ReOpen Program, submitted on February 16, 2023. XHANCE, combining fluticasone propionate with the Exhalation Delivery System™, aims to address a significant unmet need, as approximately 10 million U.S. adults with chronic rhinosinusitis lack FDA-approved treatment options. The ReOpen trials demonstrated significant improvements in symptoms and inflammation, marking a pivotal advance in chronic sinusitis management.
Optinose (NASDAQ:OPTN) appointed Ramy Mahmoud, MD, MPH as the new CEO and Board member, succeeding Peter Miller, who stepped down after nearly 13 years. Under Miller, the company saw significant growth, launching its first product, ONZETRA Xsail®, and transitioning to a commercial-stage company with XHANCE®.
Dr. Mahmoud has been with Optinose since 2010 and played a key role in product development and research. The company reiterated its financial guidance for XHANCE, expecting net revenues between $74-$78 million and operating expenses between $127-$131 million for 2022. Additionally, a supplemental New Drug Application for XHANCE's chronic sinusitis indication is expected to be submitted in February 2023.
Optinose (NASDAQ:OPTN) has appointed Paul Spence as Chief Commercial Officer. Spence brings 30 years of experience in life sciences, previously at Nestlé Health Sciences and other major pharmaceutical companies. His role will focus on the anticipated FDA approval of XHANCE for chronic sinusitis treatment, a market with approximately 30 million potential U.S. patients. Spence received a stock option grant for 500,000 shares at $1.75 as part of his inducement package. This move aims to enhance commercial strategies and capitalize on growth opportunities.
Optinose (NASDAQ:OPTN) announced that Michele Janis, Acting Chief Financial Officer, will depart for a CFO role at another company, effective December 30, 2022. CEO Peter Miller praised Janis for her over 11 years of service, highlighting her role in the company's development. Anthony Krick, Vice President, will remain as Chief Accounting Officer, overseeing financial reporting and daily financial operations. Jonathan Neely will continue leading investor relations. The company remains focused on the needs of ENT and allergy patients.
Optinose (NASDAQ:OPTN) has successfully secured $50 million from a recent financing, extending its cash runway beyond the PDUFA action date for XHANCE, a treatment for chronic sinusitis, expected in Q4 2023. The company has also amended its note purchase agreement with Pharmakon, delaying amortization to September 2025 and extending maturity to June 2027. These updates will facilitate XHANCE's growth and the submission of a supplemental NDA in early 2023. Chronic sinusitis affects up to 30 million adults in the U.S., presenting a significant market opportunity for Optinose.
Optinose (NASDAQ:OPTN) plans to submit a supplemental New Drug Application for XHANCE as a treatment for chronic sinusitis in early 2023. The company reported a Q3 2022 net revenue of $20.1 million, down 8% year-over-year. Full-year 2022 net revenue is projected between $74 to $78 million, decreased from earlier estimates of $85 to $92 million. Operating expenses for 2022 are expected to be $127 to $131 million, with a significant decrease anticipated in 2023. The company's cash balance stood at $61.1 million as of September 30, 2022.
Optinose (NASDAQ:OPTN) announced that it will present data from its ReOpen2 phase 3 clinical trial at the ACAAI 2022 Annual Scientific Meeting on November 12, 2022. This trial evaluated the efficacy of XHANCE (EDS-FLU) for treating chronic sinusitis, with results indicating significant improvements in patient-reported symptoms and inflammation. The ReOpen Program consists of two trials, with 222 patients participating in ReOpen2. XHANCE may become the first FDA-approved treatment for chronic sinusitis without nasal polyps, addressing a critical need as current options are limited.
Optinose (NASDAQ:OPTN) will report its third quarter 2022 financial results and corporate updates on November 10, 2022, before the market opens. A conference call will follow at 8:00 a.m. Eastern Time, hosted by the company’s leadership team to discuss these developments. Interested participants can access the call live via the company’s website or register for telephone access. A replay will also be available online for 60 days after the event.
Optinose (NASDAQ:OPTN) announced a significant 60% reduction in acute exacerbations and antibiotic use in chronic sinusitis patients using XHANCE. This data comes from the landmark ReOpen phase 3 clinical trial program, presented at IDWeek 2022. Chronic sinusitis impacts about 30 million adults in the U.S., costing over $30 billion annually. XHANCE is touted as a potential FDA-approved treatment for chronic sinusitis, providing hope for patients without nasal polyps.
Optinose announces that data from its ReOpen1 Phase 3 clinical trial will be presented at the ARS 68th Annual Meeting on September 9, 2022. This trial studied XHANCE as a potential treatment for chronic sinusitis, focusing on symptom relief and inflammation reduction. The study involved 332 patients and aimed to establish XHANCE as an effective treatment, potentially the first FDA-approved drug for chronic sinusitis. The ReOpen Program includes two Phase 3 trials, with ReOpen1 being the first to demonstrate improvements in patients' conditions.
