Omeros Announces FDA Approval of YARTEMLEA and Conference Call on January 7, 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 27 2025
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Source: Newsfilter
- FDA Approval Milestone: Omeros' YARTEMLEA (narsoplimab-wuug) becomes the first therapy approved for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), marking a significant breakthrough in the complement-mediated disease space and is expected to greatly improve patient outcomes.
- Market Launch Plan: YARTEMLEA is set to launch in the U.S. on January 2, 2026, and Omeros aims to bolster investor confidence and market acceptance by discussing this important milestone during the upcoming conference call.
- European Regulatory Progress: The marketing authorization application for YARTEMLEA is under review by the European Medicines Agency, with a decision expected in mid-2026, and successful approval will further enhance Omeros' international market presence.
- Addressing Patient Demand: With approximately 30,000 hematopoietic stem cell transplants performed annually in the U.S. and Europe and a TA-TMA incidence rate of up to 56%, the launch of YARTEMLEA will meet this high-demand market, boosting Omeros' market share and competitiveness.
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Analyst Views on OMER
Wall Street analysts forecast OMER stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for OMER is 43.67 USD with a low forecast of 36.00 USD and a high forecast of 55.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
4 Analyst Rating
3 Buy
1 Hold
0 Sell
Strong Buy
Current: 11.810
Low
36.00
Averages
43.67
High
55.00
Current: 11.810
Low
36.00
Averages
43.67
High
55.00
About OMER
Omeros Corporation is a clinical-stage biopharmaceutical company. The Company is focused on discovering, developing, and commercializing first-in-class small-molecule and protein therapeutics for both large-market and orphan diseases, with a particular emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders. The Company's lead MASP-2 inhibitor, narsoplimab, targets the lectin pathway of complement and is the subject of a biologics license application pending before the FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Its long-acting MASP-2 inhibitor, OMS1029, is in phase I single- and multiple-ascending-dose clinical studies. Its lead phosphodiesterase 7 (PDE7) inhibitor, OMS527, is in clinical development for the treatment of cocaine use disorders. The Company also has preclinical programs, including an oncology platform for the development of novel therapeutics.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Omeros Corporation Begins First Shipments of Yartemlea Therapy
- FDA Approval: Omeros Corporation received FDA approval in December to market Yartemlea for patients aged two and older, showcasing the company's innovative capabilities in the biotech sector.
- First Shipments: The company began its first commercial shipments of Yartemlea last week, fulfilling initial orders from multiple transplant centers, marking a critical step in product market entry and expected to significantly boost revenue.
- Therapeutic Impact: Yartemlea targets TA-TMA, which has a mortality rate exceeding 90% in severe cases, thus its launch provides a new treatment option for high-risk patients, potentially improving survival rates and quality of life.
- Market Demand: Patients currently undergoing Yartemlea therapy include adults and children who have failed prior off-label C5-inhibitor regimens in both inpatient and outpatient settings, indicating the drug's broad applicability and market potential.
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iShares U.S. Pharmaceuticals ETF Declines 1.8% on Thursday
- ETF Underperformance: The iShares U.S. Pharmaceuticals ETF fell approximately 1.8% during Thursday afternoon trading, indicating a weak performance that may undermine investor confidence.
- Weak Component Stocks: Among the ETF's weakest performers were Omeros, down about 7%, and Edgewise Therapeutics, down approximately 6.4%, highlighting the overall pressure within the pharmaceutical sector.
- Market Volatility Impact: The overall market volatility on Thursday may have exacerbated investor concerns regarding the pharmaceutical industry, leading to capital outflows that further impacted the ETF's performance.
- Investor Sentiment Shift: As pharmaceutical stocks decline, investors may reassess their investment strategies in the sector, potentially influencing future capital flows and market dynamics.
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