Welcome to our dedicated page for Omeros news (Ticker: OMER), a resource for investors and traders seeking the latest updates and insights on Omeros stock.
The Omeros Corporation (NASDAQ: OMER) news page on Stock Titan aggregates company announcements, clinical updates, regulatory milestones, and financial disclosures in one place. Omeros is a biopharmaceutical company focused on first-in-class small-molecule and protein therapeutics for complement-mediated diseases, cancers, and addictive or compulsive disorders, and its news flow reflects this broad development agenda.
A major theme in recent Omeros news is YARTEMLEA (narsoplimab-wuug), the company’s fully human monoclonal antibody that inhibits MASP-2 in the lectin pathway of complement. The U.S. FDA has approved YARTEMLEA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and children two years of age and older. News items detail the approval decision, clinical data on complete response and survival, safety information, and plans for the U.S. market launch, as well as conference calls discussing this milestone.
Investors and clinicians following OMER news will also find updates on regulatory reviews in Europe, peer-reviewed publications on TA-TMA outcomes with narsoplimab, and developments in Omeros’ broader pipeline. These include progress with OMS1029, the long-acting MASP-2 inhibitor; OMS527 for cocaine use disorder, supported by a grant from the National Institute on Drug Abuse; and oncology and Targeted Complement Activating Therapy (T-CAT) programs.
Another recurring news topic is Omeros’ strategic transactions and financing. Releases describe the asset purchase and license agreement with Novo Nordisk for the MASP-3 inhibitor zaltenibart (OMS906), including upfront and milestone payment structures and retained rights, as well as registered direct offerings, at-the-market equity sales, and quarterly financial results. Bookmark this page to review OMER headlines, official press releases, and related commentary as they are issued.
Omeros (NASDAQ:OMER) has announced a registered direct offering of common stock to raise approximately $22 million through an agreement with Polar Asset Management Partners. The company will sell 5,365,853 shares at $4.10 per share, representing a 14% premium to the closing price on July 24, 2025.
The offering is expected to close around July 28, 2025, with D. Boral Capital LLC serving as the exclusive placement agent. The offering is made pursuant to an effective S-3 shelf registration statement previously filed with the SEC.
Omeros (NASDAQ:OMER) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The submission showcases impressive clinical results, including a 61% response rate and a three-fold improvement in overall survival compared to a matched external control group.
The application includes data from over 130 TA-TMA patients treated under Omeros' expanded access program. With orphan drug designation, the review will follow a centralized procedure, potentially leading to marketing authorization across EU member states and EEA countries. A final decision is expected by mid-2026. Additionally, the FDA is reviewing the resubmitted BLA with a PDUFA date of September 25, 2025.
Omeros Corporation (Nasdaq: OMER) has announced details for its virtual Annual Meeting of Shareholders scheduled for June 27, 2025, at 10:00 a.m. Pacific Time. The meeting will be accessible through the virtual shareholder meeting website.
Shareholders of record as of May 23, 2025 will be able to attend, vote, and submit questions using their 16-digit control number. The meeting will include a business portion followed by a general corporate overview and Q&A session. A recording will be available on Omeros' corporate website after the event.
Omeros Corporation (OMER) announced that the FDA has accepted the resubmission of its Biologics License Application (BLA) for narsoplimab, targeting the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). The FDA has assigned a PDUFA date in late September 2025.
The Class 2 resubmission includes crucial data showing statistically significant and clinically meaningful improvements in survival for narsoplimab-treated patients compared to an external control group. Additional data from the company's expanded access program, treating both adult and pediatric TA-TMA patients, was also included. Omeros is currently responding to FDA information requests and plans to submit a marketing authorization application to the European Medicines Agency later this quarter.
Omeros (OMER) has established an Oncology Clinical Steering Committee to advance its OncotoX biologics program targeting acute myeloid leukemia (AML). The committee comprises distinguished clinical experts from leading National Comprehensive Cancer Network Centers, chaired by Dr. Naval Daver from MD Anderson Cancer Center.
The OncotoX-AML program features engineered molecules that deliver toxic payloads to cancer cells. In animal studies, the therapeutic has demonstrated superior efficacy to current standard treatments, showing effectiveness against tumors with mutations found in nearly 90% of AML patients. The treatment targets both AML blasts and leukemia stem cells, while preliminary studies indicate good tolerability at doses well above efficacious levels.
AML, affecting over 20,000 U.S. patients annually with 11,000+ deaths, represents a significant market opportunity. The global AML therapeutic market is projected to reach over $6 billion by 2030, within a broader leukemia therapeutic market forecast of $29 billion.
Omeros (OMER) announced the upcoming first public presentation of its proprietary Targeted Complement Activating Therapy™ (T-CAT™) platform at the European Congress on Infectious Diseases 2025. The technology represents a novel class of pathogen-targeting recombinant antibodies designed to combat multidrug-resistant organisms (MDROs).
T-CAT's unique mechanism involves engineered antibodies containing complement-cleaving enzymes that directly activate complement on microbial cell surfaces, leading to their destruction. In animal studies, T-CAT antibodies demonstrated effectiveness against life-threatening infections caused by several WHO-designated priority bacterial pathogens, showing >99% reduction in organisms and increased survival rates.
The platform aims to address the global MDRO crisis, which causes over 2.8 million resistant infections and 35,000 deaths annually in the U.S. alone. Unlike current antimicrobials, T-CAT antibodies are designed to be effective against various pathogens without promoting drug resistance. The anti-infectives market reached $46 billion in U.S. sales and $135 billion globally in 2024.
Omeros (OMER) reported Q4 2024 financial results with a net loss of $31.4 million ($0.54 per share), compared to Q3 2024's loss of $32.2 million. The full-year 2024 net loss was $156.8 million ($2.70 per share), up from $117.8 million in 2023.
Cash position stood at $90.1 million as of December 31, 2024, marking an $81.7 million decrease from 2023. Significant outlays included $21.7 million for convertible notes repurchase, $19.1 million for narsoplimab drug substance, and $1.9 million for senior debt transactions.
Key developments include the resubmission of narsoplimab BLA for TA-TMA treatment, with FDA action expected in September 2025. The company plans to submit European MAA in H1 2025. Phase 3 trials for zaltenibart in PNH treatment have begun, with data expected late next year.
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