Key Developments: Omeros Corp (OMER.OQ)

OMER.OQ on NASDAQ Stock Exchange Global Market

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19 Aug 2014
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Latest Key Developments (Source: Significant Developments)

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

FDA Grants Orphan Drug Designation to Omeros Corp's OMS824 for Huntington's Disease
Monday, 30 Sep 2013 07:00am EDT 

Omeros Corp announced that OMS824, its phosphodiesterase 10 (PDE10) inhibitor, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of Huntington's disease. Omeros plans to begin a Phase 2 clinical trial evaluating OMS824 in patients with Huntington's disease later this year.  Full Article

Omeros Corp Reports Initiation Of Phase 2 Clinical Trial With OMS824
Thursday, 19 Sep 2013 07:00am EDT 

Omeros Corporation announced initiation of enrollment in a Phase 2 clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor. The trial will evaluate the compound's tolerability, safety, pharmacokinetics, potential interactions with concomitant antipsychotic medications, and a battery of cognitive tests in patients with stable schizophrenia. The Phase 1 clinical program in healthy subjects established dosing regimens that were well tolerated and associated with high levels of PDE10 target engagement in the brain, supporting advancement of OMS824 into patient-directed trials. In this Phase 2 clinical trial, OMS824 will be administered at various dose levels for two weeks to patients whose antipsychotic medications have been temporarily discontinued or who continue their usual antipsychotic regimen in order to assess the effects of OMS824 as monotherapy and in combination with antipsychotic medications. A variety of cognitive tests will be assessed, although the relatively small size of this trial will limit the ability to detect treatment effects, if present. The safety and any efficacy findings in this trial are planned for use in determining appropriate dosing regimens and selecting endpoints for subsequent Phase 2 and Phase 3 clinical trials in schizophrenia.  Full Article

Omeros Corp Submits New Drug Application to U.S. FDA for OMS302
Thursday, 1 Aug 2013 07:00am EDT 

Omeros Corp announced that the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for approval of OMS302 for use in patients undergoing intraocular lens replacement (ILR) surgery. In addition, Omeros plans to submit a Marketing Authorization Application to the European Medicines Agency (EMA) via the EMA's centralized procedure this quarter. The Company has recently been granted designation by the EMA as a Small or Medium-Sized Enterprise (SME). Through the SME program, Omeros can benefit from elimination or reduction of certain fees related to the clinical development and approval processes in Europe for OMS302 and other Omeros products.  Full Article

Omeros Corp Obtains Regulatory Approval to Initiate Phase 1 Clinical Trial For Lead Antibody In MASP-2 Program
Thursday, 13 Jun 2013 07:00am EDT 

Omeros Corporation announced that it has obtained regulatory clearance to start the Phase 1 clinical trial evaluating OMS721, the Company's lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2 (MASP-2) program. The first clinical trial with OMS721 will be conducted in Europe and will evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 administered subcutaneously in healthy subjects. Omeros plans to follow this study with a clinical trial evaluating OMS721 in patients with atypical hemolytic uremic syndrome (aHUS), a rare but life-threatening form of thrombotic microangiopathy (TMA). Enrollment in the initial clinical trial is scheduled to begin next month.  Full Article

Omeros Corp Announces Clearence Of New Drug Application By FDA For OMS824 In Huntington's Disease
Thursday, 23 May 2013 07:00am EDT 

Omeros Corp announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S. Food and Drug Administration (FDA). OMS824 selectively inhibits phosphodiesterase 10 (PDE10), an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including Huntington's disease and schizophrenia. OMS824 has shown promising results in animal models directly relevant to Huntington's disease and, as previously announced, OMS824 was well tolerated and exhibited favorable pharmacokinetic properties in a Phase 1 clinical program. Omeros plans to advance OMS824 into Phase 2 clinical trials for Huntington's disease next quarter and for schizophrenia later this year, the OMS824 IND for use in patients with schizophrenia having already been cleared by the FDA. Omeros also announced that it has requested Orphan Drug Designation from the FDA for OMS824 in the treatment of Huntington's disease. Orphan-designated drugs are eligible for incentives such as a faster approval process and additional market exclusivity. This designation is granted to drugs that are expected to provide therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients annually.  Full Article

Eye drug wins first FDA approval for Omeros, shares rise

- Omeros Corp said the U.S. Food and Drug Administration had approved its drug for use in cataract and lens replacement surgeries, the first drug developed by the company to get marketing clearance from the regulator.

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