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355 articles with Omeros Corporation
Company Expands Leadership to Keep Pace with Advancing Pivotal Clinical Programs
Sandoz Amends ANDA to Not Seek Approval for Generic Version of OMIDRIA Until Patents for Omeros’ Drug Expire
With Voluntary Dismissal of Infringement Suit Against Sandoz, Omeros Wraps Up All Pending ANDA Litigation
Omeros’ OMS721 Receives European Orphan Drug Designation Positive Opinion for Treatment in Hematopoietic Stem Cell Transplantation
Discussions Ongoing with European Regulators for Pathway to Expedited Approval
Sales maintain the drug’s European marketing authorization
Nicotine Addiction Planned as First Indication
First Clinical Target for PDE7 Inhibitor to be Nicotine Addiction
Lupin Confirms Validity of OMIDRIA Patents
FDA Grants Breakthrough Therapy Designation to Omeros’ MASP-2 Inhibitor OMS721 for the Treatment of High-Risk Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy
Omeros Corporation announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Additional Clinical Studies Supporting the Benefits of OMIDRIA® Presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting
Omeros Corporation announced that the results of four real-world clinical studies evaluating the benefits of OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% were presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting held in Washington, D.C., April 13-17, 2018.
Omeros Corporation Announces Upcoming Presentations of New Data on OMIDRIA® at the American Society of Cataract and Refractive Surgery Meeting
Omeros Corporation (NASDAQ: OMER) today announced that the results of four studies directed to the benefits of OMIDRIA across a range of clinical situations in cataract surgery will be presented at the upcoming American Society of Cataract and Refractive Surgery (ASCRS) Congress in Washington, D.C., April 13-17, 2018.
Total year 2017 OMIDRIA revenues were $64.8 million, a 56.4 percent increase over 2016.
Omeros Corporation (NASDAQ: OMER) today announced that the company will issue its fourth quarter and year-end 2017 financial results for the period ended December 31, 2017, on Thursday, March 1, 2018, after the market closes.
Omeros Reports Significant Improvement in Overall Survival Data in OMS721-Treated Patients with Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy
The data demonstrate an increase in median overall survival in HCT-TMA patients treated with OMS721 compared to a matched historical control (347 days vs. 21 days, respectively, by Kaplan-Meier analysis; p < 0.0001 by log-rank test).
European Medicines Agency Issues Orphan Drug Designation Positive Opinion for Omeros’ OMS721 in the Treatment of IgA Nephropathy
Omeros Corporation announced today that the European Medicines Agency’s Committee for Orphan Medicinal Products issued a positive opinion on Omeros’ application for orphan drug designation of OMS721 in the treatment of primary Immunoglobulin A nephropathy (IgAN).
Omeros announced that it has reached agreement with the FDA on Omeros’ protocol for its Phase 3 clinical trial evaluating OMS721 in patients with IgA nephropathy (IgAN). Patient enrollment is expected to begin early next month.
FDA also granted OMIDRIA an additional six months of U.S. market exclusivity.
Omeros is getting a lot of love from investors and analysts these days.
Omeros today announced recent highlights and developments as well as financial results for the third quarter ended September 30, 2017, which include:
For the quarter ended September 30, 2017, total revenues were $21.7 million, all from sales of OMIDRIA.
Omeros' Extended Improvement in OMS721-Treated Patients With IgA Nephropathy Presented at American Society of Nephrology Annual Meeting
During the Phase 2 clinical trial, which consisted of 12 weeks of treatment and 6 weeks of follow-up, all patients with IgA nephropathy demonstrated clinically meaningful improvement in proteinuria.