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OptiNose, Inc. (NASDAQ: OPTN), founded in 2010 and headquartered in Yardley, Pennsylvania, is a global specialty pharmaceutical company focused on improving the lives of patients treated by ear, nose, and throat (ENT) and allergy specialists. The company is known for its innovative approach to pharmaceutical development and commercialization, aiming to offer value to both the healthcare system and its stakeholders.
OptiNose's flagship product is XHANCE (fluticasone propionate) nasal spray, a unique therapeutic that utilizes the proprietary Exhalation Delivery System (EDS). This system delivers a topical corticosteroid deep into the nasal passages to treat chronic rhinosinusitis with nasal polyps. Unlike traditional nasal sprays, XHANCE targets inflammation high and deep within the nasal passages, reaching areas previously inaccessible by standard treatments.
Recently, XHANCE was approved by the FDA for the treatment of chronic rhinosinusitis without nasal polyps, expanding its potential patient base significantly. This approval was backed by robust clinical data from the ReOpen program, consisting of two global, randomized, double-blind, placebo-controlled Phase 3 trials. These trials demonstrated significant improvement in both symptoms and inflammation for patients with chronic sinusitis, with or without nasal polyps. Some common adverse reactions included epistaxis, headache, and nasopharyngitis, consistent with its labeled safety profile.
OptiNose continues to innovate, working on faster and cost-effective product developments and exploring new commercial models. The company collaborates with ENT and allergy specialists to bring breakthrough treatments to patients, focusing on efficiency and effectiveness in all its operations. OptiNose's commitment to values and ethical practices ensures their dedication to patient care and improved health outcomes.
For the latest updates and detailed information on OptiNose's financial performance, current projects, and strategic developments, visit their website or follow them on social media platforms like X and LinkedIn.
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.
Optinose (NASDAQ:OPTN) reported a 12% increase in net revenue to $20.6 million for Q2 2022 compared to Q2 2021. The company anticipates full-year net revenue for 2022 to range between $85 million and $92 million, adjusting from a previous estimate of at least $90 million. Despite these revenues, a net loss of $19.4 million for the quarter was reported. Optinose plans to submit a supplemental New Drug Application for XHANCE targeting chronic sinusitis by late 2022, aiming to expand its market significantly.
Optinose (NASDAQ:OPTN) will report its second quarter 2022 financial results on August 11, 2022, prior to market open. The conference call for discussing these results and corporate updates is scheduled for 8:00 a.m. Eastern Time on the same day. Participants can join the call via webcast or by registering for a telephone connection. A replay of the event will be available on the company's website for 60 days. For more information about Optinose and its focus on ENT and allergy treatments, visit www.optinose.com.
Optinose (NASDAQ:OPTN) announced pivotal results from the ReOpen trials, showcasing its drug XHANCE as the first nasal medication to significantly reduce chronic sinusitis exacerbations. A pre-planned analysis revealed a notable 66% reduction in exacerbations with XHANCE (372 mcg) versus placebo over 24 weeks. Chronic sinusitis leads to approximately 10 million outpatient visits annually, heavily contributing to antibiotic prescriptions. XHANCE could transform treatment, reducing reliance on antibiotics and improving patient quality of life.
Optinose announced results from the ReOpen trials, evaluating XHANCE for chronic sinusitis treatment. The trials demonstrated significant symptom relief and improved quality of life in patients using XHANCE compared to placebo. Key findings include improved scores on congestion, facial pain, and quality of life metrics over 24 weeks, with significant p-values (<0.05). Notably, XHANCE showed a 6.31% reduction in sinus opacification in patients without nasal polyps versus a 1.55% reduction for placebo. The safety profile aligns with expectations, with increased rates of epistaxis and headaches noted.
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