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) announced a peer‑reviewed manuscript in Blood Advances reporting survival outcomes in adults with high‑risk transplant‑associated thrombotic microangiopathy (TA‑TMA) treated with narsoplimab across a pivotal trial and the global expanded access program (EAP).
The analysis found significant, multifold reductions in mortality risk for narsoplimab versus a well‑matched external control group, with consistent results across individual cohorts and pooled data. No new safety signals were observed. Narsoplimab, a MASP‑2 inhibitor targeting the lectin complement pathway, is currently under review by the U.S. FDA and the European Medicines Agency. The full manuscript is available online.
Omeros (NASDAQ:OMER) announced the publication of a peer-reviewed manuscript in the American Journal of Hematology highlighting survival outcomes for patients treated with narsoplimab through a global expanded access program. The study focused on both adult and pediatric patients with transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening condition.
The drug, which inhibits MASP-2 (the effector enzyme of the lectin pathway of complement), demonstrated excellent survival outcomes in patients receiving it as first-line therapy and in those who failed prior treatments, including C5 inhibitors. The treatment showed no concerning safety signals, consistent with previous clinical studies. Notably, narsoplimab is currently under review for marketing approval by both the U.S. FDA and European Medicines Agency.
Omeros Corporation (Nasdaq: OMER) reported Q2 2025 financial results with a reduced net loss of $25.4 million ($0.43/share), compared to $56.0 million ($0.97/share) in Q2 2024. The company secured $20.6 million through a registered direct offering with Polar Asset Management Partners at a 14% premium.
Key developments include FDA's review of narsoplimab for TA-TMA with a PDUFA date extended to December 26, 2025, and EMA's acceptance of the marketing authorization application. The company significantly improved its balance sheet by reducing near-term debt by over $100 million through note exchanges and conversions.
Omeros is in advanced discussions for potential asset deals, including one with a multi-billion dollar potential value. The company ended Q2 with $28.7 million in cash and investments, while earning $8.6 million in OMIDRIA royalties on Rayner's $28.6 million U.S. net sales.
Omeros Corporation (NASDAQ: OMER) has scheduled its second quarter 2025 financial results announcement for Thursday, August 14, 2025, after market close. The company will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the quarterly results and recent developments.
Investors can access the live webcast through Omeros' website at investor.omeros.com/upcoming-events. For phone participation, registration is required to receive a PIN. The call replay will be available at investor.omeros.com/archived-events.
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.