Welcome to our dedicated page for Omeros Corporation news (Ticker: OMER), a resource for investors and traders seeking the latest updates and insights on Omeros Corporation stock.
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) 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.
Omeros Corporation (NASDAQ: OMER) is set to release its first quarter financial results for the period ending March 31, 2022, on May 10, 2022, post-market. A conference call will follow at 4:30 p.m. ET to discuss the financial results and recent developments. Omeros focuses on developing therapeutics for immunologic diseases, with a lead product, narsoplimab, under FDA review for a specific disorder. The company has multiple late-stage clinical programs addressing various complement-mediated conditions.
Omeros Corporation (NASDAQ: OMER) announced the online publication of a manuscript detailing the results from its pivotal study on narsoplimab for treating HSCT-TMA, a severe complication following stem cell transplants. No approved treatment exists for this condition. The manuscript will appear in the Journal of Clinical Oncology and is currently available online. Narsoplimab is the subject of a biologics license application pending with the FDA. The company is also engaged in late-stage clinical programs for other complement-mediated disorders.
Omeros Corporation (Nasdaq: OMER) reported a net income of $280.6 million, or $4.48 per share, for Q4 2021, boosted by the $126 million cash from the sale of OMIDRIA. Adjusted for the divestiture, net loss was $23 million, or $0.37 per share. The company reclassified OMIDRIA operations to discontinued for prior fiscal years. Notably, the FDA issued a Complete Response Letter for narsoplimab, requesting additional data for approval. Omeros anticipates further developments in its clinical programs and retains significant cash reserves of $157.3 million as of year-end 2021.
Omeros Corporation (NASDAQ: OMER) will announce its fourth quarter and year-end financial results for the period ended December 31, 2021, on March 1, 2022, after market close. Management will host a conference call at 4:30 p.m. ET to discuss these results and recent developments. This press release highlights the company's ongoing commitment to developing therapeutics for inflammatory and immunologic diseases, such as its lead product narsoplimab, currently pending FDA approval for treating specific conditions.
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