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 Corporation (Nasdaq: OMER) reported first-quarter 2022 financial results, showing a net loss of $33.0 million or $0.53 per share, improved from a loss of $35.1 million a year earlier. The company earned $13.8 million in royalties from OMIDRIA sales by Rayner Surgical, reflecting a $6.6 million increase year-over-year. Cash reserves decreased to $142.2 million. Following an FDA meeting regarding its biologics license application for narsoplimab, Omeros plans to submit a formal dispute resolution request, confident in its data. Key upcoming events include trial data for OMS906 and OMS1029.
Omeros Corporation (NASDAQ: OMER) is set to release its first quarter financial results for the period ending March 31, 2022, on May 10, 2022, post-market. A conference call will follow at 4:30 p.m. ET to discuss the financial results and recent developments. Omeros focuses on developing therapeutics for immunologic diseases, with a lead product, narsoplimab, under FDA review for a specific disorder. The company has multiple late-stage clinical programs addressing various complement-mediated conditions.
Omeros Corporation (NASDAQ: OMER) announced the online publication of a manuscript detailing the results from its pivotal study on narsoplimab for treating HSCT-TMA, a severe complication following stem cell transplants. No approved treatment exists for this condition. The manuscript will appear in the Journal of Clinical Oncology and is currently available online. Narsoplimab is the subject of a biologics license application pending with the FDA. The company is also engaged in late-stage clinical programs for other complement-mediated disorders.
Omeros Corporation (Nasdaq: OMER) reported a net income of $280.6 million, or $4.48 per share, for Q4 2021, boosted by the $126 million cash from the sale of OMIDRIA. Adjusted for the divestiture, net loss was $23 million, or $0.37 per share. The company reclassified OMIDRIA operations to discontinued for prior fiscal years. Notably, the FDA issued a Complete Response Letter for narsoplimab, requesting additional data for approval. Omeros anticipates further developments in its clinical programs and retains significant cash reserves of $157.3 million as of year-end 2021.
Omeros Corporation (NASDAQ: OMER) will announce its fourth quarter and year-end financial results for the period ended December 31, 2021, on March 1, 2022, after market close. Management will host a conference call at 4:30 p.m. ET to discuss these results and recent developments. This press release highlights the company's ongoing commitment to developing therapeutics for inflammatory and immunologic diseases, such as its lead product narsoplimab, currently pending FDA approval for treating specific conditions.
Omeros Corporation (NASDAQ: OMER) has submitted its response to the FDA regarding the Complete Response Letter (CRL) for narsoplimab, aimed at treating HSCT-TMA. The comprehensive package was developed with external experts to address the FDA's concerns. Omeros has also requested a Type A meeting to clarify remaining issues. Narsoplimab is the first candidate for HSCT-TMA treatment, holding Breakthrough Therapy and Orphan designations. The company focuses on developing therapeutics for immunologic diseases and has ongoing late-stage clinical programs.
Omeros Corporation (NASDAQ: OMER) has finalized the sale of OMIDRIA to Rayner Surgical Group, receiving approximately $126 million in cash at closing. The agreement, valued over $1 billion, includes potential additional payments of $200 million for commercial milestones and ongoing royalties: 50% of U.S. net sales until 2025, dropping to 30% thereafter, and 15% for international sales. OMIDRIA is the first FDA-approved intraocular solution for cataract surgery, enhancing surgical outcomes.
Omeros Corporation (Nasdaq: OMER) has entered an agreement to sell OMIDRIA to Rayner Surgical Group Limited for a total value exceeding $1 billion. The deal includes an upfront payment of $125 million, an additional $200 million contingent on commercial milestones, and ongoing royalties of 50% on U.S. net sales until January 2025. The transaction, expected to close by December 31, 2021, allows Omeros to focus on its complement franchise of inhibitors. Omeros will retain a $34 million accounts receivable balance at closing.
Omeros Corporation (Nasdaq: OMER) reported a strong performance for Q3 2021, with OMIDRIA revenues reaching $30.0 million, a 4.1% increase from the previous quarter. The company's net loss narrowed to $22.7 million or $0.36 per share, down from $28.6 million or $0.46 per share in Q2. Notably, CMS reconfirmed OMIDRIA's separate payment qualification, enhancing accessibility and reimbursement for the drug. Omeros is also preparing for FDA discussions regarding narsoplimab for HSCT-TMA, alongside advancing its complement programs.
Omeros Corporation (Nasdaq: OMER) announced promising long-term results from its Phase 2 trial of narsoplimab, a MASP-2 inhibitor for IgA nephropathy. The trial demonstrated a median proteinuria reduction of 64.4 percent, potentially delaying the need for dialysis by 41.6 years compared to standard care. Long-term follow-up shows sustained improvement in estimated glomerular filtration rate (eGFR). Notably, 58 percent of patients required only one treatment course, and the therapy was well tolerated without serious adverse events. Ongoing Phase 3 trials are expected to further validate these findings.