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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 (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.
Omeros announced that its MASP-3 inhibitor zaltenibart (OMS906) received rare pediatric disease designation from the FDA for treating C3 glomerulopathy (C3G), an ultra-rare renal disorder affecting children and young adults. The company plans to initiate Phase 3 trials for C3G in 2024. Zaltenibart is also being developed for paroxysmal nocturnal hemoglobinuria (PNH), with Phase 3 studies starting this quarter. The PNH market was valued at $3.9 billion in 2023 and is projected to reach $10.1 billion by 2032. If approved, Omeros will receive a priority review voucher that can accelerate FDA review of future applications.
Omeros (OMER) reported Q2 2024 financial results:
- Net loss of $56.0 million ($0.97/share) vs $37.3 million ($0.59/share) in Q2 2023
- Cash and short-term investments of $158.9 million as of June 30, 2024
- OMIDRIA royalties of $10.9 million on $36.4 million U.S. net sales
- Entered $67.1 million initial term loan agreement
- Repurchased $118.1 million of 2026 convertible notes at 25% discount
Key clinical developments:
- Ongoing FDA discussions for narsoplimab BLA resubmission in TA-TMA
- Zaltenibart (OMS906) advancing in Phase 2 PNH trials
- OMS1029 completed Phase 1 studies, supporting quarterly dosing
Omeros (NASDAQ: OMER) has announced that it will release its financial results for the second quarter ended June 30, 2024, on Wednesday, August 7, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on the same day to discuss the financial results, recent developments, and highlights.
Investors can access the live webcast through Omeros' website at https://investor.omeros.com/upcoming-events. To join the conference call via phone, participants must register online to receive a unique PIN. A replay of the call will be available at https://investor.omeros.com/archived-events.
Omeros (Nasdaq: OMER) will host a live webcast of its Annual Meeting of Shareholders on June 6, 2024, at 10:00 a.m. Pacific Time. Shareholders of record as of April 18, 2024, can attend, vote, and submit questions online using a 16-digit control number. The meeting will include a general corporate overview and Q&A session. Guests can attend but won't have voting or questioning privileges. The event will be recorded and available later on the company's website.
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