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Omeros Corporation (symbol: OMER) is a biopharmaceutical company headquartered in Seattle, United States. The company is deeply committed to the discovery, development, and commercialization of small-molecule and protein therapeutics. Omeros targets a range of large-market and orphan indications, particularly focusing on conditions related to inflammation, coagulopathies, and central nervous system disorders.
Omeros is engaged in discovering and developing treatments for immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders. A key player in their pipeline is narsoplimab (OMS721). This proprietary, patented human monoclonal antibody targets mannan-binding lectin-associated serine protease 2 (MASP-2), which is a crucial activator of the lectin pathway of complement.
Currently, the clinical development of narsoplimab focuses on treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and immunoglobulin nephropathy (IgAN). The promising results of these studies indicate significant potential in tackling these severe conditions.
In recent achievements, Omeros has forged strategic partnerships and collaborations to propel the development of its therapeutic candidates. Financially, the corporation maintains stability through well-planned funding strategies and has shown resilience in adapting to market demands and research challenges.
Omeros Corporation is dedicated to improving patient outcomes and advancing medical science through its innovative research and development initiatives. The company's unwavering dedication to addressing unmet medical needs ensures its significant role in the biopharmaceutical landscape.
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.
Omeros Corporation (NASDAQ: OMER) will release its second quarter financial results for the period ending June 30, 2022, on August 9, 2022, after market close. A conference call will follow at 4:30 p.m. Eastern Time to discuss the results and recent developments. Omeros focuses on developing therapeutics for immunologic disorders, with a lead candidate, narsoplimab, awaiting FDA approval for HSCT-TMA. The company is also advancing other programs targeting complement-mediated disorders.
Omeros Corporation announced that its investigational drug OMS906 has received orphan drug designation from the FDA for treating paroxysmal nocturnal hemoglobinuria (PNH). The drug targets MASP-3, a key protein in the alternative complement pathway, providing potential advantages in dosing and safety. Clinical enrollment in PNH patients is set to begin this summer, following a successful Phase 1 trial. Orphan designation offers benefits such as seven years of market exclusivity and tax credits. Omeros aims to position OMS906 as a first-line therapy for PNH.
Omeros Corporation (NASDAQ: OMER) is hosting its Annual Meeting of Shareholders virtually on June 17, 2022, at 10:00 a.m. Pacific Time. Only shareholders of record as of April 14, 2022, can vote during the meeting. Shareholders can attend the meeting and submit questions online using their control number. A recording will be available for those unable to attend. Omeros develops therapeutics for immunologic diseases and has various programs, including the lead compound, narsoplimab, which targets complement-mediated disorders.
Omeros Corporation (Nasdaq: OMER) reported first-quarter 2022 financial results, showing a net loss of $33.0 million or $0.53 per share, improved from a loss of $35.1 million a year earlier. The company earned $13.8 million in royalties from OMIDRIA sales by Rayner Surgical, reflecting a $6.6 million increase year-over-year. Cash reserves decreased to $142.2 million. Following an FDA meeting regarding its biologics license application for narsoplimab, Omeros plans to submit a formal dispute resolution request, confident in its data. Key upcoming events include trial data for OMS906 and OMS1029.
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