Omeros Receives FDA Approval for YARTEMLEA to Treat TA-TMA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 24 2025
0mins
Should l Buy OMER?
Source: NASDAQ.COM
- First Effective Therapy: Omeros' YARTEMLEA becomes the first FDA-approved treatment for transplant-associated thrombotic microangiopathy (TA-TMA), addressing a critical gap in care for this high-risk condition, which has significant clinical implications.
- Clinical Trial Results: In a pivotal single-arm Phase 2 trial, YARTEMLEA achieved a complete response rate of 61%, while the expanded access program reported a 68% response rate, demonstrating its potential to improve patient outcomes significantly.
- Safety and Risk Assessment: Although 36% of patients experienced serious infections, the overall benefit-risk profile was deemed favorable, paving the way for its clinical application without the need for additional vaccinations or Risk Evaluation and Mitigation Strategies (REMS).
- Market Outlook and Strategic Plans: Omeros plans to launch YARTEMLEA in the U.S. in January 2026 and has submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in mid-2026, indicating the company's intent to expand in global markets.
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Analyst Views on OMER
Wall Street analysts forecast OMER stock price to rise
4 Analyst Rating
3 Buy
1 Hold
0 Sell
Strong Buy
Current: 11.440
Low
36.00
Averages
43.67
High
55.00
Current: 11.440
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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- 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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- Stock Potential: Among IHE's top holdings, Omeros Corp (OMER) trades at $16.38 with an analyst target of $33.67, suggesting a 105.53% upside, highlighting strong growth expectations for the stock over the next year.
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Omeros Corp Offers 26.6% Annualized Return on $10 Strike Put Options
- Options Yield Analysis: Omeros Corp's $10 strike put options offer a 26.6% annualized return, although they will only be exercised if the stock price declines by 35.1%, resulting in a cost basis of $9 per share, highlighting the delicate balance between risk and reward in options trading.
- Market Volatility Consideration: With a trailing twelve-month volatility of 146%, Omeros's stock price history provides a foundation for investors to assess the viability of selling put options, aiding in the evaluation of whether the potential returns justify the associated risks under current market conditions.
- Investment Strategy Recommendation: Given Omeros's current stock price of $15.34, the potential returns from selling options must be weighed against fundamental analysis to ensure investors make informed decisions and avoid unnecessary losses.
- Options Market Dynamics: While the only benefit for put sellers comes from collecting the premium, investors must carefully evaluate whether the potential downside risks are worth the trade-off in a highly volatile market environment.
See More
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.
See More
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.
See More
ALX Oncology Gains 10.17% on Positive Phase 2 Trial Data for Evorpacept
- Clinical Trial Progress: ALX Oncology Holdings Inc. announced positive data from its Phase 2 trial of evorpacept for indolent B-cell non-Hodgkin lymphoma, leading to a 10.17% stock increase to $1.30, with detailed results set to be presented at the ASH Annual Meeting on December 7, 2025, potentially boosting investor confidence.
- Sales Performance Surge: Globus Medical, Inc. reported preliminary unaudited Q4 2025 sales of approximately $823.2 million, a 25.2% year-over-year increase, with full-year sales expected to reach $2.936 billion, reflecting strong performance and growth potential in the medical device market.
- Future Outlook: Globus Medical set its 2026 revenue guidance between $3.18 billion and $3.22 billion, with projected non-GAAP earnings per share ranging from $4.30 to $4.40, indicating confidence in future performance that may attract more investor interest.
- Industry Developments: Acrivon Therapeutics, Inc. plans to release clinical data updates for ACR-368 and ACR-2316 on January 8, 2026, resulting in a 6.44% stock increase to $3.14, reflecting market optimism regarding its R&D progress, which could influence future financing and partnership opportunities.
See More
IHE ETF Shows 9.94% Upside Potential Based on Analyst Targets
- Analyst Target Price: The iShares U.S. Pharmaceuticals ETF (IHE) has an implied analyst target price of $93.31 per unit, while trading at $84.87, indicating a 9.94% upside potential, reflecting a generally optimistic market outlook for the ETF's future performance.
- Stock Potential: Among IHE's top holdings, Omeros Corp (OMER) trades at $16.38 with an analyst target of $33.67, suggesting a 105.53% upside, highlighting strong growth expectations for the stock over the next year.
- WVE Performance Outlook: Wave Life Sciences Ltd (WVE) is currently priced at $15.95, with an analyst target of $32.56, indicating a potential upside of 104.15%, which reflects analysts' confidence in its future performance.
- OCUL Prospects: Ocular Therapeutix Inc (OCUL) trades at $11.82, with an analyst target of $23.38, showing a 97.83% upside potential, suggesting a positive market sentiment regarding the company's future developments.
See More
Biotech Stocks Surge at Year-End 2025, ETFs Gain 35.84%
- Sector Recovery: The iShares Biotechnology ETF surged 29.51% year-to-date by December 2025, while the State Street SPDR S&P Biotech ETF achieved an even higher gain of 35.84%, indicating a significant recovery in investor confidence in the biotech sector.
- Surge in M&A Activity: Six of the year's ten largest biopharma deals occurred in Q4, with Johnson & Johnson spending $14.6 billion on Intra Cellular Therapies, signaling a strong commitment from big pharma to expand their pipelines through acquisitions.
- FDA Approvals Boost Innovation: The FDA approved 44 new therapies in 2025, with 26 approvals in the second half, including Cytokinetics' Myqorzo after 27 years, highlighting a supportive regulatory environment for innovation.
- Clinical Trial Successes: Structure Therapeutics saw its stock more than double after its obesity drug trials showed over 15% weight loss in patients, demonstrating the direct impact of clinical success on company valuations.
See More
Omeros Corp Offers 26.6% Annualized Return on $10 Strike Put Options
- Options Yield Analysis: Omeros Corp's $10 strike put options offer a 26.6% annualized return, although they will only be exercised if the stock price declines by 35.1%, resulting in a cost basis of $9 per share, highlighting the delicate balance between risk and reward in options trading.
- Market Volatility Consideration: With a trailing twelve-month volatility of 146%, Omeros's stock price history provides a foundation for investors to assess the viability of selling put options, aiding in the evaluation of whether the potential returns justify the associated risks under current market conditions.
- Investment Strategy Recommendation: Given Omeros's current stock price of $15.34, the potential returns from selling options must be weighed against fundamental analysis to ensure investors make informed decisions and avoid unnecessary losses.
- Options Market Dynamics: While the only benefit for put sellers comes from collecting the premium, investors must carefully evaluate whether the potential downside risks are worth the trade-off in a highly volatile market environment.
See More
