Omeros Corporation - OMER STOCK NEWS

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.

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.