Last $11.27 USD
Change Today -0.06 / -0.53%
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As of 8:10 PM 04/17/14 All times are local (Market data is delayed by at least 15 minutes).

omeros corp (OMER) Key Developments

Omeros Corporation announces Investigational New Drug Application Cleared by FDA for OMS721 in Thrombotic Microangiopathies

Omeros Corporation announced that its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement--mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration (FDA). OMS721 is the company's human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system. FDA's clearance of the IND allows the initiation of the Phase 2 program for OMS721, which will assess the efficacy and safety of OMS721 in patients with disorders associated with lectin pathway activation. The first OMS721 Phase 2 clinical trial, planned to begin later this quarter, will evaluate the effects of the drug on patients with TMAs, including atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenic purpura (TTP), and stem cell transplant-related TMA. The lectin pathway, one of the principal complement activation pathways in the immune system, is thought to play a central role in the development of TMAs, and OMS721, by targeting and inhibiting MASP-2, blocks the lectin pathway. Omeros controls the worldwide rights to MASP-2 inhibition and to all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. MASP-2 appears to be unique to, and required for the function of, one of the principal complement activation pathways, known as the lectin pathway. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection, and its abnormal function is associated with a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into the circulation.

Omeros Corporation Presents at 13th Annual Needham Healthcare Conference, Apr-09-2014 03:00 PM

Omeros Corporation Presents at 13th Annual Needham Healthcare Conference, Apr-09-2014 03:00 PM. Venue: The Westin Grand Central Hotel, New York, New York, United States. Speakers: Gregory A. Demopulos, Co-Founder, Chairman, Chief Executive Officer and President.

Omeros Corporation Auditor Raises 'Going Concern' Doubt

Omeros Corporation filed its 10-K on Mar 13, 2014 for the period ending Dec 31, 2013. In this report its auditor, Ernst & Young LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern.

Omeros Corporation Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Year Ended December 31, 2013

Omeros Corporation reported unaudited consolidated earnings results for the fourth quarter and year ended December 31, 2013. For the quarter, the company reported revenue of $169,000 compared to $1,583,000 a year ago. Loss from operations was $13,902,000 compared to $7,533,000 a year ago. Net loss was $1,845,000 compared to $7,734,000 a year ago. Basic and diluted net loss per share was $0.05 compared to $0.30 a year ago. For the full year, the company reported revenue of $1,600,000 compared to $6,022,000 a year ago. Loss from operations was $50,516,000 compared to $36,885,000 a year ago. Net loss was $39,796,000 compared to $38,444,000 a year ago. Basic and diluted net loss per share was $1.39 compared to $1.59 a year ago. The decrease in revenue was primarily due to lower deferred revenue being recognized from the GPCR funding agreements, which were fully amortized in the first quarter of 2013.

Omeros Announces Positive OMS721 Data in Serum from Patients with aHUS

Omeros Corporation announced positive data using OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2) program, in ex vivo studies of endothelial activation relevant to the pathophysiology of human atypical hemolytic uremic syndrome (aHUS), a form of thrombotic microangiopathy (TMA). In February 2014, Omeros reported positive results from its OMS721 Phase 1 clinical trial and, earlier March 2014, announced submission of an investigational new drug application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial in patients with TMA, including patients with aHUS. The data announced on March 10, 2014 resulted from studies conducted in support of the clinical evaluation of OMS721 by Prof. Giuseppe Remuzzi and colleagues Marina Noris and Miriam Galbusera at the Mario Negri Institute for Pharmacological Research in Bergamo, Italy, and the Clinical Research Center for Rare Diseases "Aldo e Cele Dacco" of the same Institute, a European center for collecting and studying TMA samples. The experimental model is based on the finding that serum samples from aHUS patients cause complement deposition and thrombus formation when incubated with human microvascular endothelial cells. The data reported on March 10, 2014 showed that OMS721 significantly inhibited complement deposition in the model using serum samples from aHUS patients obtained during the acute phase of disease (p<0.01) and during remission (p<0.001) compared to untreated controls. Experiments evaluating the effects of OMS721 on thrombus formation are planned. Prof. Remuzzi's laboratories have previously shown in this same model system that treatment with agents that block the complement factor C5 has a similar inhibitory effect on complement deposition. Eculizumab (Soliris(R)) is an anti-C5 monoclonal antibody that is approved by the FDA and the European Medicines Agency to treat patients with aHUS. Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. MASP-2 appears to be unique to, and required for the function of, one of the principal complement activation pathways, known as the lectin pathway. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection, and its abnormal function is associated with a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into the circulation. Adult humans who are genetically deficient in one of the proteins that activate MASP-2 do not appear to be detrimentally affected by the deficiency. Therefore, Omeros believes that it may be possible to deliver MASP-2 antibodies systemically and OMS721, its MASP-2 antibody, is designed to be self-administered by subcutaneous injection. Omeros also believes that it has identified the proteins that activate the complement system's alternative pathway in humans, which is linked to a wide range of immune-related disorders. In addition to its lectin pathway inhibitors, the Company is advancing the development of antibodies that would block activation of the alternative pathway alone or in combination with the lectin pathway.

 

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