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Omeros Corporation (NASDAQ: OMER) is a Seattle-based clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative small-molecule and protein therapeutics. The company targets both large-market and orphan indications, with a primary focus on addressing unmet medical needs in areas such as inflammation, coagulopathies, and central nervous system disorders. By leveraging its proprietary technologies and scientific expertise, Omeros aims to develop transformative therapies that improve patient outcomes in complex and underserved medical conditions.
Omeros' flagship drug candidate, narsoplimab (OMS721), exemplifies its commitment to precision medicine. Narsoplimab is a proprietary, patented human monoclonal antibody designed to inhibit mannan-binding lectin-associated serine protease 2 (MASP-2), the key activator of the lectin pathway of the complement system. This pathway plays a critical role in immune responses and is implicated in various complement-mediated diseases. Narsoplimab is currently undergoing clinical trials for applications in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and immunoglobulin A nephropathy (IgAN), highlighting its potential to address life-threatening and chronic conditions.
In addition to narsoplimab, Omeros is advancing a robust pipeline of therapeutic candidates targeting immunologic disorders, including complement-mediated diseases, cancers, and addictive and compulsive disorders. This diversified approach positions the company to address a broad spectrum of medical needs, ranging from rare diseases to more prevalent conditions.
Operating within the highly competitive biopharmaceutical industry, Omeros differentiates itself through its focus on proprietary drug development platforms and its expertise in complement biology. The company's strategic emphasis on both large-market and orphan indications allows it to pursue scalable revenue opportunities while addressing critical gaps in patient care. This dual focus is particularly significant in the context of industry trends favoring biologics and targeted therapies for rare and complex diseases.
Omeros' business model is built on a foundation of innovation and scientific rigor. By investing in advanced research and development, the company aims to bring novel therapies from the laboratory to the clinic and, ultimately, to patients. This commitment to innovation is complemented by a strong focus on intellectual property, ensuring the protection and exclusivity of its therapeutic candidates.
In summary, Omeros Corporation is a pioneering force in the biopharmaceutical sector, leveraging its expertise in small-molecule and protein therapeutics to address some of the most challenging medical conditions. With a focus on complement-mediated diseases and a robust pipeline of drug candidates, the company is well-positioned to make a significant impact in both large-market and orphan indications. Its dedication to scientific excellence and patient-centric innovation underscores its role as a key player in the evolving landscape of precision medicine.
Omeros Corporation (Nasdaq: OMER) announced the publication of a study in the Journal of Neuroscience, highlighting the effects of phosphodiesterase 7 (PDE7) inhibitors on nicotine consumption. The research demonstrated that these inhibitors, including Omeros' OMS527, significantly reduced nicotine use in rodent models without abuse potential. PDE7 inhibition potentially offers a new avenue for treating addiction, including smoking cessation. Omeros holds global rights to PDE7 inhibitors for addiction disorders and continues to advance its therapeutic pipeline.
Omeros Corporation (Nasdaq: OMER) announced that Gregory A. Demopulos, M.D., CEO, will present at the BofA 2021 Napa BioPharma Virtual Conference on June 15, 2021, at 4:30 p.m. EDT. The presentation will be a fireside chat with analyst Geoff Meacham, PhD. Interested parties can access the live and archived webcast at Omeros Upcoming Events, available for 30 days post-event.
Omeros is focused on developing therapeutics for inflammation and immunologic diseases, with products like OMIDRIA and lead candidate narsoplimab under FDA review.
Omeros Corporation (Nasdaq: OMER) announced preliminary results from its Phase 1 trial of MASP-3 inhibitor OMS906. The study, involving healthy volunteers, demonstrates that OMS906 is well tolerated at all tested doses with no safety concerns. Key findings include a significant suppression of mature CFD for up to 4 weeks following administration of the drug. The trial supports the potential for once-monthly subcutaneous dosing. Omeros aims to advance OMS906 to Phase 2 trials, reinforcing its commitment to developing therapies for complement-mediated diseases.
Omeros Corporation (Nasdaq: OMER) has released preliminary results from a compassionate use study of its lead drug, narsoplimab, in critically ill COVID-19 patients in Bergamo, Italy. The cohort included ten patients, all with significant comorbidities and severe acute respiratory distress syndrome (ARDS). Notably, 80% of the patients recovered and were discharged. The drug is designed to target endothelial damage in COVID-19. Narsoplimab also holds Breakthrough Therapy designation and is under review by the FDA for other serious conditions. Further clinical trial data is expected.
Omeros Corporation (Nasdaq: OMER) announced that the FDA requires additional time to review the Biologics License Application (BLA) for narsoplimab, aimed at treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The new PDUFA target action date is set for October 17, 2021. Omeros recently submitted a major amendment to the BLA in response to an FDA information request, demonstrating ongoing engagement with the agency. Narsoplimab has received Breakthrough Therapy and Orphan designations and is the first drug submitted for approval in HSCT-TMA.
Omeros Corporation (Nasdaq: OMER) announced that data from its pivotal trial of narsoplimab for HSCT-TMA will be presented at the 2021 EHA Virtual Congress. Dr. Miguel-Angel Perales will present findings on the drug's impact on organ function improvement in high-risk patients. Narsoplimab, a human monoclonal antibody, is currently under priority review by the U.S. FDA for HSCT-TMA treatment and has received numerous designations, including breakthrough therapy. The condition HSCT-TMA is serious, with up to 90% mortality in severe cases, and no approved therapies currently exist.
Omeros Corporation (Nasdaq: OMER) reported strong first-quarter 2021 results, with OMIDRIA revenues rising to $21.1 million from $10.6 million last quarter. The net loss decreased to $35.1 million (or $0.57 per share), compared to $37.3 million (or $0.60 per share) previously. As of March 31, 2021, cash and equivalents reached $100.5 million. Notably, the FDA is reviewing Omeros' Biologics License Application for narsoplimab, with a decision expected by July 17, 2021. The company is also advancing multiple clinical programs, including trials for COVID-19 therapies.
Omeros Corporation (NASDAQ: OMER) will release its first-quarter financial results for the period ending March 31, 2021, on May 10, 2021, post-market. A conference call is scheduled for the same day at 4:30 p.m. Eastern Time to discuss the results and recent developments. Omeros is a biopharmaceutical firm focused on therapeutics for inflammation and complement-mediated diseases. Its products include OMIDRIA and the investigational drug narsoplimab, which is under FDA priority review for thrombotic microangiopathy.
Omeros Corporation (Nasdaq: OMER) announces the CDC's approval of an ICD-10 code for hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA). This code, effective October 1, 2021, will enhance diagnosis accuracy and reporting of HSCT-TMA cases. Additionally, CMS approved two ICD-10-PCS codes for administering narsoplimab, an investigational therapy for HSCT-TMA, aimed at improving billing and reimbursement processes. Narsoplimab is under FDA priority review and has received several designations, including breakthrough therapy status.
Omeros Corporation (Nasdaq: OMER) has begun dosing patients with narsoplimab in the I-SPY COVID-19 Trial, which aims to identify effective treatments for critically ill COVID-19 patients. This adaptive trial, sponsored by Quantum Leap Healthcare Collaborative, focuses on reducing mortality and minimizing mechanical ventilation duration. Narsoplimab, targeting MASP-2, is the only complement inhibitor in the trial, with positive outcomes in compassionate use cases. Omeros anticipates valuable data from this collaboration, especially as SARS-CoV-2 variants continue to spread.
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