Omeros Corporation - OMER STOCK NEWS

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.

Omeros Corporation (NASDAQ: OMER) presented the first report on narsoplimab's effects on complement activation markers in kidney disease at the American Society of Nephrology Annual Meeting. A 21-year-old patient with rapidly progressive glomerulonephritis showed significant improvement in kidney function after treatment with narsoplimab, allowing her to undergo successful transplantation. Urinary complement levels dropped significantly during treatment. Narsoplimab is also under FDA review for various indications, including IgA nephropathy and HSCT-TMA.

Omeros Corporation (NASDAQ: OMER) announced it will release its third quarter financial results for the period ending September 30, 2021, on November 9, 2021, after market close. A conference call will be held at 4:30 p.m. ET to discuss the results and recent developments. The company continues to focus on developing therapeutics for inflammation and immunologic diseases, with products like OMIDRIA gaining market share.

Omeros Corporation (NASDAQ: OMER) received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for narsoplimab, aimed at treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). The FDA expressed challenges in evaluating the treatment's effect and requested additional information for regulatory approval. Omeros remains confident in narsoplimab's efficacy and plans to engage in discussions with the FDA to outline the path forward. Narsoplimab is the first drug candidate submitted for HSCT-TMA with Breakthrough Therapy and Orphan designations.

Omeros Corporation (Nasdaq: OMER) announced that the FDA identified deficiencies in its Biologics License Application (BLA) for narsoplimab, a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). This notification prevents discussions on labeling and post-marketing commitments at this time. The company does not expect these issues to be resolved by the October 17, 2021 target action date. Narsoplimab is the first drug submitted for HSCT-TMA approval and holds Breakthrough Therapy and Orphan Drug designations.

Omeros Corporation (Nasdaq: OMER) reported strong financial results for Q2 2021, with OMIDRIA revenues reaching $28.8 million, a 37% increase from Q1 2021. The net loss narrowed to $28.6 million ($0.46 per share), improving from a loss of $35.1 million in the prior quarter. The company's cash position stood at $73.7 million. A priority review of Omeros' Biologics License Application for narsoplimab is set for October 17, 2021. Recent positive clinical data supports ongoing development of OMS906, a MASP-3 inhibitor, marking significant progress in Omeros' pipeline.