Welcome to our dedicated page for Omeros news (Ticker: OMER), a resource for investors and traders seeking the latest updates and insights on Omeros stock.
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) received a $200 million milestone payment from Rayner Surgical due to the Asset Purchase Agreement for OMIDRIA®. This payment, received on February 3, 2023, is expected to support Omeros' operations well into 2025. U.S. net sales of OMIDRIA reached $131 million in 2022, with growth anticipated from regulatory changes ensuring separate payment for non-opioid pain management drugs. Omeros will continue earning royalties, with rates decreasing from 50% to 30% for U.S. sales post-milestone. The funds will be utilized for clinical studies, commercialization, and other strategic purposes.
Omeros Corporation (Nasdaq: OMER) reported third-quarter 2022 earnings, generating $16.5 million in royalties from the sales of OMIDRIA, accounting for 50% of Rayner's $33.0 million net sales. The company posted a net loss of $17.5 million ($0.28 per share), an improvement from $22.7 million in Q3 2021. A $125 million sale of future OMIDRIA royalties to DRI Healthcare Acquisitions was also completed. The FDA denied the resubmission request for narsoplimab but offered a path forward for its BLA based on survival data, which is critical for future development and approvals.
Omeros Corporation announced that the FDA's Office of New Drugs has denied its appeal for immediate labeling discussions regarding its biologics license application (BLA) for narsoplimab, aimed at treating thrombotic microangiopathy. However, the decision outlines a potential path for BLA resubmission based on survival data from completed trials compared to historical controls. The company plans to discuss the implications of this decision in its upcoming earnings call on November 9, 2022. Narsoplimab is the first drug candidate submitted to the FDA for this indication.
Omeros Corporation (NASDAQ: OMER) will release its third-quarter financial results on November 9, 2022, after market close. A conference call will be held at 4:30 PM ET on the same day to discuss the results and recent developments. The company is focused on developing therapeutics for immunologic disorders, with its lead product, narsoplimab, under a biologics license application for treating HSCT-TMA. This product is also part of ongoing clinical trials for other conditions, including IgA nephropathy and COVID-19.
Omeros Corporation (Nasdaq: OMER) will present two studies on its investigational complement inhibitors at the 64th American Society of Hematology Annual Meeting from December 10-13, 2022, in New Orleans. The first presentation focuses on the safety and pharmacokinetics of the MASP-3 inhibitor OMS906 (Abstract #2570), scheduled for December 11. The second presentation evaluates the MASP-2 inhibitor Narsoplimab for pediatric patients with HSCT-TMA (Abstract #3808) on December 12. Poster details will be available on Omeros' website post-meeting.
Omeros Corporation (NASDAQ: OMER) has successfully sold a portion of its projected royalty payments from OMIDRIA to DRI Healthcare Acquisitions LP, generating $125 million in gross proceeds. This sale, finalized under a Royalty Purchase Agreement dated September 30, 2022, allows DRI to receive royalty payments on net sales until December 31, 2030, capped at various amounts annually. Omeros retains a significant portion of future revenues from OMIDRIA and has no dilution of stockholders. The transaction positions Omeros to secure substantial funding without impacting its balance sheet.
Omeros Corporation (NASDAQ: OMER) announced significant findings from the I-SPY COVID Trial, indicating that the addition of narsoplimab reduces the mortality risk in critically ill COVID-19 patients (HR=0.81). The trial involved 91 patients in the narsoplimab group compared to 116 in the control group, with no new safety signals identified. However, narsoplimab did not expedite recovery times. Despite some treatment limitations, a substantial efficacy signal was observed, highlighting narsoplimab's potential in severe acute COVID-19 management.
Quantum Leap Healthcare Collaborative (QLHC) and Omeros Corporation (NASDAQ: OMER) announced the closure of enrollment and analysis of the narsoplimab arm in the I-SPY COVID Trial. The study revealed that narsoplimab, when added to standard care in critically ill COVID-19 patients, reduces mortality risk (HR=0.81, p<0.77). A total of 91 patients were randomized, showing no new safety signals for narsoplimab. The trial intends to enhance treatment outcomes for severely ill COVID-19 patients through innovative clinical trial designs.
Omeros Corporation (NASDAQ: OMER) has received an interim response from the FDA regarding its dispute resolution request concerning the biologics license application for narsoplimab, aimed at treating HSCT-TMA. The FDA's Office of New Drugs is collecting additional information before issuing a final decision within 30 days. Narsoplimab is the first drug candidate submitted for HSCT-TMA and holds Breakthrough Therapy and Orphan Designations. Omeros continues to develop narsoplimab for other conditions, including IgA nephropathy and COVID-19.
Omeros Corporation (Nasdaq: OMER) reported a net loss of $30.9 million or $0.49 per share for Q2 2022, which includes $3.7 million in non-cash expenses. This is a slight increase from a net loss of $28.6 million in Q2 2021. The company earned $17.2 million in royalties on net sales of OMIDRIA, reflecting a record high from Rayner Surgical's sales. Omeros has $122.6 million in cash and short-term investments as of June 30, 2022. Key upcoming milestones include a decision on narsoplimab's FDA approval expected in August 2022 and significant clinical trials for other promising therapies.
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