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Omeros Corporation (symbol: OMER) is a biopharmaceutical company headquartered in Seattle, United States. The company is deeply committed to the discovery, development, and commercialization of small-molecule and protein therapeutics. Omeros targets a range of large-market and orphan indications, particularly focusing on conditions related to inflammation, coagulopathies, and central nervous system disorders.
Omeros is engaged in discovering and developing treatments for immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders. A key player in their pipeline is narsoplimab (OMS721). This proprietary, patented human monoclonal antibody targets mannan-binding lectin-associated serine protease 2 (MASP-2), which is a crucial activator of the lectin pathway of complement.
Currently, the clinical development of narsoplimab focuses on treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and immunoglobulin nephropathy (IgAN). The promising results of these studies indicate significant potential in tackling these severe conditions.
In recent achievements, Omeros has forged strategic partnerships and collaborations to propel the development of its therapeutic candidates. Financially, the corporation maintains stability through well-planned funding strategies and has shown resilience in adapting to market demands and research challenges.
Omeros Corporation is dedicated to improving patient outcomes and advancing medical science through its innovative research and development initiatives. The company's unwavering dedication to addressing unmet medical needs ensures its significant role in the biopharmaceutical landscape.
Omeros (NASDAQ: OMER) announced robust statistical analysis results for narsoplimab's Expanded Access Program (EAP) in treating transplant-associated thrombotic microangiopathy (TA-TMA). The analysis showed that narsoplimab significantly reduced mortality risk in high-risk TA-TMA patients by 2-3 fold (hazard ratio = 0.34-0.46) with highly significant p-values (<0.00001).
The EAP included 136 TA-TMA patients, with impressive survival rates: 62% one-year survival for previously untreated patients (58% adults, 79% children) and 44% for treatment-refractory patients - more than double the historical survival rate of <20%. The results will be included in narsoplimab's BLA resubmission to FDA this quarter and MAA submission to European regulators by mid-year.
No safety concerns were identified, and the data consistently demonstrated narsoplimab's effectiveness in treating TA-TMA, a life-threatening complication with no currently approved treatment.
Omeros (OMER) has made available on its website materials from two presentations delivered at the 2025 Tandem Meetings, focusing on narsoplimab treatment outcomes. The presentations include survival data from Dr. Michelle Schoettler's study of 128 allogeneic transplant patients with TA-TMA treated under the expanded access program, and Dr. Piyatida Chumnumsiriwath's poster on outcomes from adult TA-TMA patients who received narsoplimab after unsuccessful eculizumab treatment.
Omeros (NASDAQ: OMER) has announced two upcoming presentations at the 2025 Tandem Meetings in Honolulu, Hawaii, focusing on narsoplimab treatment outcomes for TA-TMA patients under an expanded access program. The first presentation, by Dr. Michelle Schoettler from Emory University School of Medicine, will discuss overall survival rates among 128 allogeneic transplant patients treated with narsoplimab.
The second presentation, by Dr. Piyatida Chumnumsiriwath from UC Irvine, will showcase findings from a single-center study of adult TA-TMA patients who received narsoplimab after unsuccessful eculizumab treatment. Both presentations are scheduled for February 13, 2025, with Dr. Schoettler's podium presentation at 3:15 PM HST and Dr. Chumnumsiriwath's poster session at 6:45 PM HST.
Omeros (NASDAQ: OMER) announced positive statistical sensitivity analysis results for narsoplimab in treating transplant-associated thrombotic microangiopathy (TA-TMA). The analyses validate previously reported primary endpoint results showing 2-fold to 4-fold reduction in mortality risk (hazard ratios 0.24-0.42) with p-values ranging from 0.0124 to <0.00001.
The primary endpoint analysis demonstrated an over 3-fold reduction in mortality risk (hazard ratio = 0.32) in narsoplimab-treated patients compared to external control. The company plans to resubmit its Biologics License Application (BLA) to FDA this quarter and targets Marketing Authorization Application (MAA) submission to European regulators by mid-year. Narsoplimab aims to become the first approved treatment for TA-TMA, a life-threatening complication in stem cell transplantation.
Omeros (OMER) announced successful results from its narsoplimab pivotal trial for treating transplant-associated thrombotic microangiopathy (TA-TMA). The primary statistical analysis showed that patients treated with narsoplimab had an over 3-fold reduction in mortality risk (hazard ratio = 0.32) compared to untreated patients in an external control group.
The study compared 28 narsoplimab-treated TA-TMA patients against more than 100 similar high-risk patients from a stem cell transplant registry. The results were highly statistically significant (p < 0.00001). Based on these positive outcomes, Omeros will resubmit its Biologics License Application (BLA) to FDA, aiming to make narsoplimab the first approved treatment for TA-TMA.
Omeros (OMER) presented two posters about zaltenibart (OMS906), their investigational MASP-3 inhibitor, at the ASH Annual Meeting. The presentations focused on Phase 2 clinical data and clinical pharmacology analyses for treating paroxysmal nocturnal hemoglobinuria (PNH).
The Phase 2 'switch-over' study showed that zaltenibart monotherapy achieved sustained improvements in hemoglobin and absolute reticulocyte count in PNH patients who had inadequate response to ravulizumab. The treatment was well-tolerated with no concerning safety signals.
Pharmacokinetic/pharmacodynamic modeling identified 8mg/kg as the optimal intravenous dose administered every 8 weeks, achieving >98% suppression of alternative pathway activation. Phase 3 clinical trials are expected to begin enrollment in early 2025.
Omeros (NASDAQ: OMER) has announced two upcoming presentations about zaltenibart (OMS906), their investigational MASP-3 inhibitor, at the 66th Annual Meeting of the American Society of Hematology (ASH) in San Diego, December 7-10, 2024. The presentations focus on treating paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder.
The presentations include interim results from a Phase 2 proof-of-concept study showing improved hematologic parameters in PNH patients, and a pharmacokinetics/pharmacodynamics study. Phase 3 clinical trials for zaltenibart in PNH are scheduled to begin in early 2025.
Omeros (Nasdaq: OMER) has provided an update on its progress toward resubmitting its biologics license application (BLA) for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The company has received FDA's response on the revised statistical analysis plan (SAP) and has no other presubmission requests pending. An independent expert statistical group will conduct data analyses, and if results support resubmission, the company plans to finalize and resubmit the BLA promptly. The FDA's recent feedback included recommendations for additional sensitivity analyses, which Omeros has accepted.
Omeros (OMER) reported Q3 2024 financial results with a net loss of $32.2 million ($0.56 per share), compared to $37.8 million ($0.60 per share) in Q3 2023. The company held $123.2 million in cash and short-term investments, down $48.7 million from December 2023. OMIDRIA royalties were $9.3 million on $31.0 million U.S. net sales. Key developments include FDA discussions for narsoplimab BLA resubmission in TA-TMA, planned European MAA submission in H1 2025, and advancement of zaltenibart's Phase 2 program in PNH with Phase 3 enrollment expected in early 2025.
Omeros (NASDAQ: OMER) has scheduled its third quarter 2024 financial results announcement for Wednesday, November 13, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss financial results, recent developments, and highlights. Participants can access the webcast through Omeros' website or join via phone by registering for a unique PIN. A replay will be available on the company's website.
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