Key Developments: Omeros Corp (OMER.OQ)

OMER.OQ on NASDAQ Stock Exchange Global Market

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3 Aug 2015
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Latest Key Developments (Source: Significant Developments)

Omeros Corporation announces positive OMS721 Data in Serum from patients with aHUS
Monday, 10 Mar 2014 07:00am EDT 

Omeros Corporation:Positive data using OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2) program.Thrombotic microangiopathy (TMA) are a family of rare, debilitating and life-threatening disorders characterized by multiple thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain.Phase 2 clinical trial in aHUS and other TMAs expected to begin next quarter.  Full Article

Omeros Corp reports additional positive data from its oms824 phase 2a schizophrenia clinical trial
Thursday, 6 Mar 2014 07:00am EST 

Omeros Corp:Says additional positive results from a Phase 2a clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor.Patients with schizophrenia were administered a higher dose than had been evaluated in any OMS824 trial, which resulted in about 50 pct higher plasma concentrations than did the previously reported highest dose and had a similar side-effect profile to those of the lower doses.OMS824 inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease.The results reported today were in psychiatrically stable patients who continued their usual antipsychotic regimen and received OMS824 or placebo for 14 days.The positive results across all doses tested in this Phase 2a trial indicate that OMS824 can be administered in combination with standard antipsychotic medications.Says that, at tolerated doses, yields plasma concentrations that are predicted to achieve a high degree of PDE10 target interaction in the striatum.  Full Article

Omeros Corp submits IND to advance OMS721 phase two clinical program
Tuesday, 4 Mar 2014 07:00am EST 

Omeros Corp:Says it has submitted to the USFDA an investigational new drug (IND) application to initiate the Phase two clinical program for OMS721.OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin*associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system.Last month Omeros announced positive data following completion of dosing in the Phase one clinical trial of OMS721, which was conducted in the Netherlands under a Clinical Trial Application.The initial Phase two clinical trial is an open-label, two-stage ascending-dose-escalation trial in adult subjects with TMA.The objectives of the trial are to evaluate efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of OMS721 in patients with TMAs, including aHUS, TTP and transplant-related TMA.  Full Article

Omeros Corp reports additional positive phase 1 clinical data for Oms824 for the treatment of cognitive disorders
Tuesday, 11 Feb 2014 07:00am EST 

Omeros Corp:Says additional positive data from its Phase 1 program for OMS824, the lead compound in Omeros' phosphodiesterase 10 (PDE10) program.This clinical trial evaluated the extent to which OMS824 binds to PDE10, an enzyme expressed in the region of the brain that has been linked to a wide range of diseases that affect cognition.Says the latest cohort enrolled in this trial, OMS824 achieved a high of about 70 percent engagement at PDE10 without evidence of extrapyramidal symptoms (EPS).Says it is completing a Phase 2a trial evaluating the drug in patients with schizophrenia and will start enrollment in a Phase 2 trial for Huntington's disease this quarter.  Full Article

Omeros Corp announces positive data after completion of dosing in phase 1 clinical trial with OMS721
Monday, 3 Feb 2014 07:00am EST 

Omeros Corp:Says positive data following completion of dosing in a phase one clinical trial of OMS721.Says OMS721, administered either by subcutaneous injection or intravenous infusion, was well tolerated and achieved the objective of a high degree of sustained lectin pathway inhibition.Says it expects to initiate a phase two clinical program to evaluate OMS721 in the treatment of thrombotic microangiopathies (TMAs), including atypical hemolytic uremic syndrome, that occurs in the microcirculation of the body's organs, most commonly the kidney and brain, later this quarter.Says the positive results in the phase one trial enable selection of the dose levels to be evaluated in the phase two program, which will assess the safety and efficacy of OMS721 in patients with disorders thought to involve lectin pathway activation, including TMAs.  Full Article

Omeros Corp reports positive results from OMS824 phase 2a clinical trial
Wednesday, 29 Jan 2014 07:00am EST 

Omeros Corp:Says positive results from a Phase 2a clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor.Says OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease.  Full Article

Omeros Corp Announces Positive Data in Phase 1 Clinical Trial with OMS721
Thursday, 7 Nov 2013 07:30am EST 

Omeros Corporation announced positive clinical data in a Phase 1 clinical trial of OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), an important regulator of the lectin pathway of the immune system. Subcutaneous administration of OMS721 achieved a high degree of lectin pathway inhibition. The drug was well tolerated and no drug-related adverse events were observed. A Phase 2 clinical program to evaluate OMS721 in the treatment of thrombotic microangiopathies (TMAs), a family of disorders that occurs in the microcirculation of the body's organs, commonly the kidney and brain, is expected to begin enrollment in early 2014.  Full Article

Omeros Corp Reports Additional Positive Clinical Data For Drug Candidate To Treat Cognitive Disorders
Thursday, 17 Oct 2013 07:00am EDT 

Omeros Corporation announced additional positive data from its Phase 1 program for OMS824, the lead compound in Omeros' phosphodiesterase 10 (PDE10) program. This latest clinical trial evaluated the extent to which OMS824, at a dose higher than previously reported, binds to PDE10, an enzyme expressed in the region of the brain that has been linked to a wide range of diseases that affect cognition. OMS824 achieved an average of 63% engagement at PDE10 and did not trigger the dose-limiting side effects seen with other PDE10 inhibitors. These data further support advancing OMS824 through clinical trials in patients with cognitive disorders. Last month, Omeros started a Phase 2 trial evaluating the drug in patients with schizophrenia and plans to start a Phase 2 trial in Huntington's disease later this year. The results reported were in healthy male subjects receiving OMS824 once daily for seven days at a dose higher than those previously evaluated in the target-engagement clinical trial. Positron emission tomography (PET) scans were used to measure the binding activity of OMS824 to PDE10 in the brain. An average of 63% occupancy at PDE10 was seen in the basal ganglia, the region of the brain that plays a critical role in cognition. The drug was well tolerated with mild somnolence as the only apparent side effect.  Full Article

Omeros Corp Announces Management Change-Form 8-K
Wednesday, 16 Oct 2013 07:08am EDT 

Omeros Corp reported in its Form 8-K that on October 15, 2013, the Board of Directors of Omeros Corp (Omeros) appointed Michael A. Jacobsen as Vice President, Finance and Chief Accounting Officer, and designated Mr. Jacobsen as the company’s principal financial officer and principal accounting officer. On such date, Gregory A. Demopulos, M.D., Omeros’ President, Chief Executive Officer and Chairman of the Board of Directors, ceased to serve as the Company’s interim Chief Financial Officer and its principal accounting officer.  Full Article

Omeros Corp Settles Insurance Litigation
Thursday, 3 Oct 2013 08:00am EDT 

Omeros Corp announced that it entered into a settlement agreement with its insurer, Carolina Casualty Insurance Company (CCIC), related to CCIC's defense of, and coverage obligations owed to, Omeros and its chief executive officer and chairman, Gregory A. Demopulos, M.D., in previously settled litigation with Omeros' former chief financial officer. The settlement includes a release of each party's respective claims in the insurance coverage lawsuit and payment by CCIC of $12.5 million to Omeros by October 25, 2013. While Dr. Demopulos released all of his claims in exchange for this settlement, he elected to receive no portion of the settlement funds and to have all proceeds be paid to Omeros.  Full Article

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