Articles from Omeros Corporation

Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2024, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter and year ended December 31, 2024, on Monday, March 31, 2025, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today reported that clinical trial site activation for enrollment is underway for the company’s Phase 3 program evaluating zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH). Zaltenibart (OMS906) is Omeros’ investigational inhibitor of MASP-3, the key and most proximal activator of the alternative pathway of complement. Zaltenibart inhibits the intravascular hemolysis treated by C5 inhibitors as well as the extravascular hemolysis caused by C5 inhibitors in patients suffering from PNH while leaving intact the infection-fighting lytic arm of the classical pathway of complement.

Omeros Corporation (Nasdaq: OMER) today announced that it has received a funding commitment from the National Institute on Drug Abuse (NIDA) for the upcoming year (April 1, 2025 through March 31, 2026) in the amount of $4.02 million for clinical development of its lead orally administered phosphodiesterase 7 (PDE7) inhibitor OMS527 to treat cocaine use disorder (CUD), reducing or eliminating craving and relapse in patients with CUD. This grant will fund the Phase 1b clinical trial in patients with CUD to assess OMS527 safety and efficacy, with initial data readout expected in the fourth quarter of this year. NIDA’s $4.02 million award was triggered by the successful outcome of drug-drug-interaction safety studies, also funded by NIDA and routinely required by the U.S. Food and Drug Administration (FDA), in which OMS527 was administered in conjunction with cocaine in two animal species to rule out enhancement of the detrimental effects of cocaine. OMS527 showed no enhancement of these detrimental effects; instead, OMS527 was beneficial to cocaine-administered animals. There is no approved treatment for patients with CUD.

Omeros Corporation (Nasdaq: OMER) today announced statistical analysis results related to the expanded access program (EAP) for narsoplimab, Omeros’ first-in-class monoclonal antibody inhibiting the lectin pathway of complement, in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication in both adult and pediatric hematopoietic stem cell transplantation (HSCT). These latest analyses, conducted by an independent statistical group, comprise multiple survival comparisons between narsoplimab-treated EAP patients and similarly at-risk TA-TMA patients in the external control registry. The results from these analyses further support the robustness of the previously reported results from the statistical analysis plan agreed with FDA, with representative analyses of the combined EAP and pivotal trial patients yielding hazard ratios ranging from 0.34 (95 percent confidence interval: 0.21, 0.53) to 0.46 (95 percent confidence interval: 0.35, 0.60) and p-values ranging from less than 0.00001 to 0.00002. Consistent with all previous clinical experience with narsoplimab, no safety signals of concern were observed.

Omeros Corporation (Nasdaq: OMER) today announced the availability on its website of materials accompanying two presentations given at the 2025 Tandem Meetings – the Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplant Research.

Omeros Corporation (Nasdaq: OMER) today announced two presentations that will be featured at the 2025 Tandem Meetings – the Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplant Research, to be held February 12-15, 2025 in Honolulu, Hawaii.

Omeros Corporation (Nasdaq: OMER) today announced statistical sensitivity analysis results related to the primary endpoint analysis for narsoplimab, Omeros’ first-in-class monoclonal antibody inhibiting the lectin pathway of complement, in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication in both adult and pediatric hematopoietic stem cell transplantation. The sensitivity analyses, conducted by an independent statistical group, demonstrate the robustness of the results of the previously reported primary endpoint analysis, with representative hazard ratios ranging from 0.24 (95 percent confidence interval: 0.13, 0.47) to 0.42 (95 percent confidence interval: 0.21, 0.83) and p-values ranging from less than 0.00001 to 0.0124.

Omeros Corporation (Nasdaq: OMER) today announced that an independent statistical group has completed the primary statistical analysis agreed with the FDA for narsoplimab, Omeros’ first-in-class monoclonal antibody inhibiting the lectin pathway of complement, in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication in both adult and pediatric hematopoietic stem cell transplantation (HSCT). The analysis compared overall survival in the 28 TA-TMA patients in OMS721-TMA-001, Omeros’ previously conducted pivotal trial for narsoplimab in TA-TMA, to that of more than 100 similarly high-risk TA-TMA patients in an external control registry of HSCT patients who did not receive narsoplimab treatment. Narsoplimab met its primary endpoint, with OMS721-TMA-001 patients demonstrating clinically meaningful and statistically significant superiority in overall survival – a hazard ratio of 0.32 (95% confidence interval: 0.23 to 0.44) with p-value less than 0.00001 – compared to the TA-TMA registry patients. Given these results, Omeros will resubmit to FDA as soon as possible its narsoplimab Biologics License Application (BLA) for TA-TMA. Omeros aims to make narsoplimab, which targets the lectin pathway’s effector enzyme MASP-2, the first approved treatment for TA-TMA.

Omeros Corporation (Nasdaq: OMER) today announced that two posters directed to zaltenibart (OMS906), Omeros’ investigational inhibitor of MASP-3, the key and most proximal activator of the alternative pathway of complement, were presented at the 66th Annual Meeting of the American Society of Hematology (ASH) yesterday in San Diego. The posters, both addressing zaltenibart in paroxysmal nocturnal hemoglobinuria (PNH) – a rare, life-threatening hematological disorder – detail positive Phase 2 clinical data and clinical pharmacology analyses supporting zaltenibart dose selection for the PNH Phase 3 program. Enrollment for the zaltenibart Phase 3 clinical trials in PNH is expected to open in early 2025.

Omeros Corporation (Nasdaq: OMER) today announced that two abstracts directed to zaltenibart (OMS906), Omeros’ investigational inhibitor of MASP-3, the key activator of the alternative pathway of complement, will be presented at the 66th Annual Meeting of the American Society of Hematology (ASH), to be held December 7-10, 2024 in San Diego. The zaltenibart abstracts are directed to the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening hematological disorder. Enrollment for the zaltenibart Phase 3 clinical trials in PNH is expected to open in early 2025.

Omeros Corporation (Nasdaq: OMER) today announced an update on its progress toward planned resubmission of its biologics license application (“BLA”) for narsoplimab, the company’s first-in-class antibody targeting MASP-2, the effector enzyme of the lectin pathway of complement, in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”). In last week’s quarterly earnings release and associated call, Omeros stated that it was awaiting feedback from the U.S. Food and Drug Administration (“FDA”) on the company’s revised statistical analysis plan (“SAP”) for the BLA. Omeros has now received FDA’s response on the revised SAP, has no other presubmission information requests pending and is not aware of any other impediment to resubmitting the narsoplimab BLA. Following data preparation, primary endpoint and other analyses will be conducted by an independent expert statistical group. If the analytical results support resubmission of the BLA, the company plans to finalize and resubmit the BLA as soon as possible.

Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the third quarter ended September 30, 2024, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter ended September 30, 2024, on Wednesday, November 13, 2024, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation today announced that zaltenibart (OMS906) has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the treatment of complement 3 glomerulopathy (C3G), an ultra-rare, progressive renal disorder primarily afflicting children and young adults. Caused by dysregulation of the alternative pathway of complement, there is no approved treatment for C3G, which often leads to end-stage renal disease within 10 years of diagnosis. Zaltenibart is the most proximal inhibitor of the alternative pathway. It blocks mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the alternative pathway, stopping the conversion of pro-complement factor D (pro-CFD) to mature CFD. Phase 3 clinical trials for zaltenibart in C3G are slated to begin next year.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, as well as cancers and addictive and compulsive disorders, today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2024, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter ended June 30, 2024, on Wednesday, August 7, 2024, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today announced that the company will host a live webcast of its Annual Meeting of Shareholders, which will be held virtually on Thursday, June 6, 2024, starting at 10:00 a.m. Pacific Time.

Omeros Corporation (Nasdaq: OMER) today announced that it has completed a series of strategic financial transactions, further strengthening its balance sheet and extending the maturity profile on a substantial portion of its debt from February 2026 to June 2028, while providing a secure source of capital to support potential commercialization of its lectin pathway inhibitor narsoplimab and flexibility to manage the remaining balance of 2026 convertible notes.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced recent highlights and developments as well as financial results for the first quarter ended March 31, 2024, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter and year ended March 31, 2024, on Wednesday, May 15, 2024, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today announced that interim analysis data from its ongoing Phase 2 study of OMS906 in patients with paroxysmal nocturnal hemoglobinuria submitted to the 2024 European Hematology Association (EHA) Hybrid Congress has been selected for podium presentation. The EHA Congress will be held June 13-16, 2024, in Madrid, Spain. OMS906 is Omeros’ investigational inhibitor of MASP-3 targeting the alternative pathway of complement. Two additional poster presentations directed to OMS906 will also be featured at the congress.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2023, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter and year ended December 31, 2023, on Monday, April 1, 2024, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today announced the upcoming presentation of a report detailing narsoplimab treatment in nine adult patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Narsoplimab is Omeros’ investigational antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system.

Omeros Corporation (Nasdaq: OMER) today announced the sale to DRI Healthcare Acquisitions LP (“DRI”), a wholly owned subsidiary of DRI Healthcare Trust, of an expanded interest in certain royalty payments based on net sales of OMIDRIA in the United States.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced recent highlights and developments as well as financial results for the third quarter ended September 30, 2023, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter ended September 30, 2023, on Thursday, November 9, 2023, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today announced online publication of a report detailing treatment with narsoplimab of 15 adult and pediatric patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), 14 of whom had “high-risk” TA-TMA. Narsoplimab is Omeros’ investigational antibody targeting MASP-2, the effector enzyme of the lectin pathway of the complement system. The report was authored by an external group of investigators involved in the treatment of these patients with narsoplimab provided under Omeros’ compassionate use program.

Omeros Corporation (Nasdaq: OMER) today announced that two abstracts directed to OMS906, Omeros’ investigational inhibitor of MASP-3, the key activator of the alternative pathway of complement, will be presented at the 65th Annual Meeting of the American Society of Hematology (ASH), to be held December 9-12, 2023 in San Diego.

Omeros Corporation (Nasdaq: OMER) today announced that Andreas Grauer, M.D., has been named Omeros’ chief medical officer. In his new role, Dr. Grauer will be responsible for guiding all clinical activities globally for the company, including clinical development and operations, medical affairs, safety, and biometrics. A highly tenured physician, scientist and pharmaceutical leader, Dr. Grauer brings to Omeros over 20 years of industry experience across a broad range of therapeutic areas including inflammation, nephrology, oncology, neurology, endocrinology, and metabolism.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today provided an update regarding the interim analysis outcome in ARTEMIS-IGAN, the Company’s Phase 3 trial evaluating narsoplimab for the treatment of immunoglobulin A (IgA) nephropathy.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2023, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its financial results for the quarter ended June 30, 2023, on Wednesday, August 9, 2023, before the market opens. Omeros management will host a conference call and webcast that same day at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER), today announced that the company will host a live webcast of its Annual Meeting of Shareholders, which will be held virtually on Friday, June 23, 2023, starting at 10:00 a.m. Pacific Time.

Omeros Corporation (Nasdaq: OMER) today announced that the slides presented yesterday in the “late-breaker” session at the 2023 European Hematology Association (EHA) Congress in Frankfurt, Germany are now available on Omeros’ website. The presentation, which details data from a pre-specified interim analysis from the ongoing Phase 1b clinical trial of Omeros’ lead MASP-3 inhibitor OMS906 in complement-inhibitor-naïve adults with paroxysmal nocturnal hemoglobinuria (PNH), was identified by EHA’s Scientific Program Committee as one of the top five late-breaking submissions and selected for oral presentation. The presentation, entitled OMS906, A mannan-binding lectin-associated serine protease-3 (MASP-3) Inhibitor, Normalizes Hemoglobin Levels in Treatment-naïve PNH Patients: Interim Data from a Proof-of-Concept Clinical Trial, was delivered to a large audience by Jens Panse, MD, Senior Physician and Deputy Director of the Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, and Managing Medical Director of the Center for Integrated Oncology, Aachen, Germany.

Omeros Corporation (Nasdaq: OMER) today announced that data from a pre-specified interim analysis of its ongoing Phase 1b clinical trial of OMS906, the company’s lead MASP-3 inhibitor, in complement-inhibitor-naïve adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening hemolytic blood disorder, will be shared at the 2023 European Hematology Association (EHA) Congress in Frankfurt, Germany. Identified as one of the top five late-breaking submissions by the Scientific Program Committee, the abstract was selected for oral presentation.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced recent highlights and developments as well as financial results for the first quarter ended March 31, 2023, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its first quarter financial results for the period ended March 31, 2023, on Tuesday, May 9, 2023, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today announced positive results from a pre-specified interim analysis of its ongoing Phase 1b clinical trial of OMS906, the company’s lead MASP-3 inhibitor, in complement-inhibitor-naïve adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening hemolytic blood disorder. Statistically significant and clinically meaningful improvements were observed in all measured markers of hemolysis, including hemoglobin (Hgb) and lactate dehydrogenase (LDH). To date, all patients have received only the lowest subcutaneous dose of OMS906 in this multidose trial.

Omeros Corporation (Nasdaq: OMER) today announced that it has been awarded a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, to develop Omeros’ lead orally administered compound from its proprietary phosphodiesterase 7 (PDE7) program OMS527 for the treatment of cocaine use disorder (CUD). The grant is expected to provide $6.69 million over three years and is intended to support both preclinical cocaine interaction studies and a clinical study evaluating the safety and efficacy of OMS527 in patients with CUD.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2022, which include:

Omeros Corporation (Nasdaq: OMER), in response to investor inquiries, is confirming that it has no banking or other financial relationship with Silicon Valley Bank.

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its fourth quarter and year-end financial results for the period ended December 31, 2022, on Monday, March 13, 2023, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today announced that Rayner Surgical, Inc. (“Rayner”) has paid the $200 million milestone payment due to Omeros under the Asset Purchase Agreement, dated December 1, 2021 (the “Agreement”), pursuant to which Omeros sold its ophthalmology product OMIDRIA® to Rayner in December of 2021.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation and immunologic diseases, including complement-mediated diseases and cancers, today announced recent highlights and developments as well as financial results for the third quarter ended September 30, 2022, which include:

Omeros Corporation (Nasdaq: OMER) today announced that the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) has reached a decision on the company’s formal dispute resolution request appealing the issuance by FDA’s Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) and the Division of Nonmalignant Hematology (the review division) of a complete response letter (CRL) concerning the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its third quarter financial results for the period ended September 30, 2022, on Wednesday, November 9, 2022, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today announced that two presentations pertaining to Omeros’ investigational complement inhibitors will be featured at the upcoming 64th American Society of Hematology (ASH) Annual Meeting, which will be held from December 10-13, 2022 in New Orleans. The following abstracts were published today and are now available on the ASH website at www.hematology.org:

Omeros Corporation (Nasdaq: OMER) today announced that Omeros has sold to DRI Healthcare Acquisitions LP (“DRI”), a wholly owned subsidiary of DRI Healthcare Trust, an interest in certain royalty payments based on net sales of OMIDRIA (the “Purchased Receivables”). The royalties payable to DRI comprise a portion of the royalties projected to be paid under the terms of the Asset Purchase Agreement (the “Asset Purchase Agreement”), among Omeros, Rayner Surgical Inc. (“Rayner Surgical”) and Rayner Surgical Group Limited, pursuant to which Omeros sold OMIDRIA and related business assets to Rayner Surgical in December 2021.

Omeros Corporation (Nasdaq: OMER) today reported results from the narsoplimab arm of the I-SPY COVID Trial, sponsored by Quantum Leap Healthcare Collaborative (QLHC). Analysis in the randomized patient population shows that the addition of narsoplimab to treatment of critically ill patients with COVID-19 reduces the mortality risk (hazard ratio [HR]=0.81, with probability [HR <1] equal to 0.77). Narsoplimab showed the largest reduction in mortality risk to date across all drugs reported from the I-SPY COVID Trial.

Omeros Corporation (Nasdaq: OMER) today announced that the United States Food and Drug Administration (FDA) provided an interim response to the company’s formal dispute resolution request submitted to the Agency in June, appealing the earlier decision by the FDA review division to issue a complete response letter for the biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). Formal dispute resolution is an official pathway that enables a sponsor to appeal a decision by an FDA division to a higher authority within the Agency, in this case the Office of New Drugs (OND). As part of FDA’s standard procedures for dispute resolution, Omeros and OND met last month to discuss the appeal. Per FDA guidelines for formal dispute resolution, a final decision from OND was to be rendered within 30 calendar days of the meeting unless the deciding official in OND required additional information. According to FDA’s interim response, the deciding official is collecting additional information, and a response to Omeros’ appeal will be provided within 30 days from the date that the additional information is collected and any required follow-up is conducted by the deciding official.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation and immunologic diseases, including complement-mediated diseases and cancers, today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2022, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its second quarter financial results for the period ended June 30, 2022, on Tuesday, August 9, 2022, after the market closes. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation today announced that OMS906 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). OMS906 targets mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the alternative pathway of the complement system. MASP-3 converts pro-complement factor D (pro-CFD) to mature CFD.

Omeros Corporation (Nasdaq: OMER), today announced that the company will host a live webcast of its Annual Meeting of Shareholders, which will be held virtually, on Friday, June 17, 2022, starting at 10:00 a.m. Pacific Time.

Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation and immunologic diseases, including complement-mediated diseases and cancers, today announced recent highlights and developments as well as financial results for the first quarter ended March 31, 2022, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its first quarter financial results for the period ended March 31, 2022, on Tuesday, May 10, 2022, after the market closes. Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today announced the online publication of a manuscript detailing the results of its pivotal study assessing efficacy and safety of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), an often-lethal complication of stem-cell transplantation for which there is no approved treatment. The manuscript – Narsoplimab, a Mannan-Binding Lectin-Associated Serine Protease-2 Inhibitor, for the Treatment of Adult Hematopoietic Stem-Cell Transplantation–Associated Thrombotic Microangiopathy – will be published in an upcoming volume of the Journal of Clinical Oncology (JCO) and yesterday was made available online by JCO, the flagship publication of the American Society of Clinical Oncology.

Omeros Corporation (NASDAQ: OMER) today announced that the company will issue its fourth quarter and year-end financial results for the period ended December 31, 2021, on Tuesday, March 1, 2022, after the market closes. Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today confirmed that earlier this month the company submitted to the U.S. Food and Drug Administration (FDA) its response to the Agency’s Complete Response Letter (CRL) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The response comprises a comprehensive briefing package drafted in close collaboration with external clinical, regulatory and legal experts that addresses in detail the points raised by FDA in its CRL for narsoplimab. Omeros concurrently requested a Type A meeting with FDA to resolve any outstanding items.

Omeros Corporation (Nasdaq: OMER) today announced that it has completed the sale of OMIDRIA (phenylephrine and ketorolac intraocular solution) 1.0%/0.3% to Rayner Surgical Group Inc., an affiliate of Rayner Surgical Group Limited. The transaction was completed pursuant to an Asset Purchase Agreement that was announced on December 2, 2021.

Omeros Corporation (Nasdaq: OMER) today announced that it has entered into a definitive agreement for the sale of OMIDRIA to Rayner Surgical Group Limited. Expected to close on or before December 31, 2021, the transaction includes an upfront payment of $125 million with an additional $200 million in a commercial milestone payment. Omeros will also retain its accounts receivable balance at the closing, which was $34 million at the end of last quarter. Together with substantial royalties to be paid by Rayner to Omeros on net sales of OMIDRIA, the transaction is valued in excess of $1 billion.

Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced recent highlights and developments as well as financial results for the third quarter ended September 30, 2021, which include:

Omeros Corporation (Nasdaq: OMER) today announced results of long-term follow-up from the Phase 2 clinical trial evaluating its MASP-2 inhibitor narsoplimab in patients with IgA nephropathy. Treatment with narsoplimab in this trial was associated with an unprecedented median reduction in proteinuria of 64.4 percent. Now, long-term follow-up (out to 35 months) of these patients shows a markedly slowed rate of decline of estimated glomerular filtration rate (eGFR). Using the same analytical approach adopted by other companies* to determine the impact of proteinuria reduction on long-term risk of need for dialysis, a 64.4 percent reduction in proteinuria is predicted to delay progression to renal dialysis by 41.6 years compared to standard of care. While other companies have reported up to 1-year follow-up data on eGFR, this is the first time that sustained stabilization, let alone improvement, of eGFR through long-term follow-up has been reported for any novel therapeutic in development for IgA nephropathy. ARTEMIS-IGAN, the Phase 3 clinical trial of narsoplimab in IgA nephropathy, is ongoing.

Omeros Corporation (Nasdaq: OMER) today announced that the first report describing the effects of lectin-pathway inhibition by narsoplimab on urinary complement levels in kidney disease was presented yesterday at the Annual Meeting of the American Society of Nephrology (ASN). The work, conducted by a consortium from Denmark and the United Kingdom and led by Peter Garred, MD, DMSc, Chair and Professor of Clinical Molecular Medicine at the University of Copenhagen, was detailed at the ASN Annual Meeting in a poster entitled “Reduction of Urinary Levels of Lectin Pathway Complement Components in an IgA Vasculitis Patient after MASP-2 Inhibition with Narsoplimab”.

Omeros Corporation (NASDAQ: OMER) today announced that the company will issue its third quarter financial results for the period ended September 30, 2021, on Tuesday, November 9, 2021, after the market closes. Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today announced that the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Omeros Corporation (Nasdaq: OMER) today announced that the U.S. Food and Drug Administration (FDA) notified the company that, as part of FDA’s ongoing review of the company’s Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. FDA stated that the notification does not reflect a final decision on the information under review.

Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2021, which include:

Omeros Corporation (NASDAQ: OMER), today announced that the company will issue its second quarter financial results for the period ended June 30, 2021, on Monday, August 9, 2021, after the market closes. Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results as well as recent developments and highlights.

Omeros Corporation (Nasdaq: OMER) today announced that data on organ function improvement from its pivotal trial of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) were shared during an oral presentation at the virtual edition of the 26th Congress of the European Hematology Association (EHA). The presentation, entitled Narsoplimab (OMS721) Treatment Contributes to Improvements in Organ Function in Adult Patients with High-Risk Transplant-Associated Thrombotic Microangiopathy, was delivered last Friday by Miguel-Angel Perales, M.D., Chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center. The organ function improvement data presented underscore the potential of narsoplimab as a significant advance in the treatment of often fatal HSCT-TMA.

Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced publication of the article “Selective inhibition of phosphodiesterase 7 enzymes reduces motivation for nicotine use through modulation of mesolimbic dopaminergic transmission” in the peer-reviewed Journal of Neuroscience.

Omeros Corporation (Nasdaq: OMER), today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the BofA 2021 Napa BioPharma Virtual Conference next week. The fireside chat with Bank of America analyst, Geoff Meacham, PhD, is scheduled for Tuesday, June 15, 2021 at 4:30 p.m. EDT.

Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, today announced preliminary results from the Phase 1 clinical trial of its MASP-3 inhibitor OMS906. The ongoing trial is designed as a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) and subcutaneous (SC) administration of OMS906 to healthy adult volunteers. OMS906 has been well tolerated at all doses tested. Preliminary human PK and PD data are consistent with once-monthly SC dosing.