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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, Inc. (NASDAQ:OPTN), a pharmaceutical company focused on ENT and allergy patients, announced the granting of non-qualified stock option awards for 54,000 shares to three new employees on April 17, 2023. The stock options, granted outside of the 2010 Stock Incentive Plan, are in accordance with Nasdaq Listing Rule 5635(c)(4). The exercise price is set at $2.05, matching the closing stock price on the grant date. The options have a 10-year term and will vest over four years, with one-fourth vesting on the first anniversary and the rest in monthly installments, contingent on continued service with the company.
Optinose (NASDAQ:OPTN) has announced that its management team will present a company overview and business update at the Needham Virtual Healthcare Conference on April 17, 2023, at 3:45 p.m. ET. Interested parties can tune in to the live webcast through the Investors page of the Optinose website. A replay of the presentation will be accessible for 30 days post-event.
Optinose specializes in providing treatments for patients attended to by ear, nose, and throat (ENT) and allergy specialists. The company aims to address specific needs within this domain. For further details, visit www.optinose.com or follow them on social media platforms such as Twitter and LinkedIn.
Optinose (NASDAQ:OPTN) reported net revenues of $20.9 million for Q4 2022, down 7% from the previous year, and $76.3 million for the full year, marking a 4% increase. The decline in Q4 revenues is attributed to fewer prescriptions for XHANCE. The company recently submitted an sNDA to the FDA for a new indication of XHANCE as a treatment for chronic rhinosinusitis, expecting a decision by May 2023. For 2023, Optinose forecasts total revenues from XHANCE to be $62 million to $68 million, with reductions in operating expenses by approximately $30 million.
Optinose (NASDAQ:OPTN) announced that it will report its fourth quarter 2022 financial results and corporate updates on March 7, 2023, before market open. The company, which focuses on patients treated by ENT and allergy specialists, will host a conference call at 8:00 a.m. Eastern Time on the same day. Participants can access the call via a webcast on the company’s website or join by telephone after prior registration. A replay of the event will be available for 60 days following its conclusion.
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.