Omeros Corporation - Common Stock (OMER)

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.