Core Viewpoint - Omeros Corporation is discussing its newly approved drug, YARTEMLEA, and its expectations regarding demand, manufacturing capacity, and commercial sales [2][3]. Group 1: Company Operations - The conference call includes forward-looking statements about Omeros' operations and assets, particularly focusing on YARTEMLEA [2]. - Management's current expectations and beliefs are subject to risks and uncertainties that could lead to actual results differing from projections [3]. Group 2: Drug Approval and Market Expectations - YARTEMLEA has received approval, and the company anticipates significant demand and commercial sales [2]. - The discussion will cover aspects such as reimbursement and development in additional indications for YARTEMLEA [2].

Omeros will price its recently approved drug for a life-threatening transplant complication in adults and children aged two and older at $36,000 per single-dose vial, CEO Gregory Demopulos said on a call with analysts on Wednesday. ...

Summary of Omeros Corporation Conference Call Company Overview - **Company**: Omeros Corporation - **Product**: Yarcomlia (narsoplimab) - **Industry**: Biotechnology, specifically focused on treatments for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TATMA) Key Points FDA Approval and Product Launch - Yarcomlia received FDA approval on December 23, 2025, marking it as the first and only therapy approved for TATMA, a life-threatening complication of stem cell transplantation [3][4] - The approval is a significant milestone for Omeros, being their second FDA-approved product after Omidria [4] - The commercial launch of Yarcomlia began on January 2, 2026, with a fully trained commercial team reaching out to U.S. transplant centers [9][10] Clinical Data and Efficacy - Approval was based on a pivotal trial involving 28 patients and an expanded access program with 221 patients [5] - Yarcomlia demonstrated a 61% complete response rate in the pivotal study and a 68% rate in the expanded access program [6] - The 100-day survival rate post-TMA diagnosis was 73% in the pivotal study and 74% in the expanded access program [6] - In high-risk patients who had failed other treatments, Yarcomlia achieved a 50% one-year survival rate compared to historical rates of less than 20% [8] Safety Profile - Yarcomlia has a differentiated safety profile with no box warning, no risk evaluation and mitigation strategy (REMS), and no vaccination requirement, unlike other off-label therapies [5][8] - Historical use of C5 inhibitors, such as eculizumab, has been associated with significantly higher risks of infection and mortality [9][36] Market Opportunity and Commercial Strategy - Approximately 11,000 allogeneic transplants are performed annually in the U.S., with TATMA developing in up to 56% of these cases [10][48] - Omeros plans to prioritize the top 80 transplant centers that account for about 80% of procedures [10] - The initial price for Yarcomlia is set at approximately $36,000 per vial, with median utilization expected to be 8 to 10 vials per treatment course [12] - A national ICD-10 diagnostic code for TATMA and specific CPT codes for Yarcomlia have been established to facilitate reimbursement [12][38] Reimbursement and Financial Support - Omeros has applied for a new technology add-on payment (NTAP) to assist with costs for Medicare patients, expected to be effective in October 2026 [13][25] - The company has a robust reimbursement strategy in place, including personalized assistance programs for providers [14] Future Plans and Pipeline - Omeros is evaluating partnerships for the commercialization of Yarcomlia outside the U.S. and plans to expand its indications [15] - The company aims to advance its long-acting MASP2 inhibitor, OMS 1029, and its MASP2 small molecule program [15] - The focus is on making Yarcomlia the standard of care for TATMA and ensuring reliable supply and access [43][54] Expert Insights - Experts on the call emphasized the importance of early intervention with Yarcomlia, which could lead to better patient outcomes compared to historical treatment approaches [17][19] - The shift in treatment paradigms is expected to improve overall management of TATMA patients, allowing for continued use of immunosuppressive therapies [19][22] Conclusion - The approval and launch of Yarcomlia represent a significant advancement in the treatment of TATMA, with a clear objective to establish it as the standard of care [43][54] - Omeros is committed to executing its strategy effectively to ensure patient access and improve clinical outcomes for those affected by TATMA [54]

Key Takeaways OMER secured FDA approval for YARTEMLEA to treat TA-TMA in adults and pediatric patients aged two and older.OMER showed strong results, with complete responses up to 68% and improved 100-day survival in studies.OMER's first commercial product is set to generate revenues, with U.S. delivery planned for January 2026.Omeros Corporation (OMER) recently announced that the FDA approved its YARTEMLEA (narsoplimab-wuug) to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy ...

Core Insights - The article emphasizes the importance of conducting independent research before making investment decisions, highlighting the inherent volatility and risks associated with stock investments [2][3]. Group 1 - The content is intended to provide informational insights rather than exhaustive analysis of any featured company [2]. - The predictions and opinions presented are based on a probabilistic approach, indicating that they do not guarantee absolute certainty [2]. - Readers are encouraged to verify the information independently and assess their financial circumstances before investing [2]. Group 2 - The article clarifies that past performance is not indicative of future results, and no specific investment recommendations are provided [3]. - It notes that the views expressed may not reflect those of the platform as a whole, emphasizing the diversity of opinions among analysts [3]. - The authors of the analysis may not be licensed or certified, which could impact the reliability of the insights provided [3].

Core Viewpoint - Omeros Corporation announced a revised date for its conference call to discuss the FDA approval of YARTEMLEA® (narsoplimab-wuug), the first therapy approved for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) [1] Group 1 - The conference call is rescheduled to Wednesday, January 7, to ensure broad participation [1] - The change in schedule accommodates shareholders' and investors' holiday plans following the significant milestone of FDA approval [1]

奥麦罗制药(OMER.US)盘前跌4.95%报14.6美元；该股上一交易日(12月24日)大幅收涨75.54%，盘中股 价创2021年5月以来逾4年半新高。消息面上，该公司宣布，美国食品药品监督管理局(FDA)已批准 YARTEMLEA(纳索普利单抗-wuug)用于治疗造血干细胞移植相关性血栓性微血管病(TA-TMA)，这是一 种由补体凝集素途径激活引起的、通常会致命的干细胞移植并发症。YARTEMLEA是首个也是唯一获批 的凝集素通路抑制剂。(格隆汇) | OMER 奥麦罗制药 | | O | | --- | --- | --- | | 15.360↑+6.610 +75.54% 收盘价 12/24 13:00 美东 | | | | 14.600 ↓ -0.760 -4.95% | | 盘前价 12/26 04:50 美东 | | 一 5 24 ~ 8 目 ♥ 白 一 白 一 | | ● 快捷交易 | | 最高价 17.650 | 开盘价 16.440 | 成交量 2450.92万 | | 最低价 13.920 | 昨收价 8.750 | 成交额 3.78亿 | | 平均价 15.423 | 市盈率ITM ...

Market Overview - Wall Street experienced a modest rally with the S&P 500 closing up 0.2%, marking a year-to-date gain of 17% [1] - The Dow Jones Industrial Average rose 0.6% to 48,731.16, while the S&P 500 closed at 6,932.05 and the Nasdaq increased by 0.22% to 23,613.30 [1] Nike Inc. - Nike's stock surged 4.64% to close at $60, with an intraday high of $60.58 and a low of $58.88; the 52-week range is between $82.44 and $52.28 [1] - CEO Tim Cook purchased 50,000 shares of Nike at an average price of $58.97, totaling nearly $3 million, increasing his stake to approximately $6.0 million [2][3] - Nike reported second-quarter revenue of $12.43 billion and earnings per share (EPS) of 53 cents, exceeding estimates, but warned of potential low single-digit revenue decline in the third quarter due to a $1.5 billion annualized tariff headwind and ongoing weakness in China [3] Omeros Corporation - Omeros shares increased by 75.54% to close at $15.36, with an intraday high of $17.65 and a low of $13.92; the 52-week range is $17.65 to $2.95 [4] - The FDA approved Omeros' Yartemlea for treating transplant-associated thrombotic microangiopathy, with studies showing complete response rates of about 61%-68% and 100-day survival rates of roughly 73%-74% [5] Micron Technology Inc. - Micron's shares rose 3.77% to close at $286.68, reaching an intraday high of $289.30 and a low of $277.25; the 52-week range is $289.30 to $61.54 [6] - The company reported first-quarter revenue of $13.64 billion and adjusted earnings of $4.78 per share, driven by its role in artificial intelligence infrastructure, with projected growth in high-bandwidth memory from $35 billion in 2025 to $100 billion by 2028 [7] Intel Corporation - Intel's stock dipped 0.52% to close at $36.16, with an intraday high of $36.17 and a low of $34.95; the 52-week range is between $44.01 and $17.67 [8] - A report indicated that Nvidia paused testing Intel's 18A manufacturing process for advanced AI chips, impacting Intel's efforts to attract major foundry customers [9][10] Dynavax Technologies Corporation - Dynavax shares jumped 38.19% to close at $15.38, with an intraday high of $15.49 and a low of $15.38; the 52-week range is $15.49 to $9.20 [11] - Sanofi announced its acquisition of Dynavax for about $2.2 billion, adding a marketed adult hepatitis B vaccine to its portfolio, with a planned payment of $15.50 per share, representing a 39% premium [12]

Core Insights - Omeros has received FDA approval for its drug Yartemlea, marking a significant milestone for the company and leading to a nearly 76% increase in its stock price [1][2][6] Company Overview - Omeros is preparing for the launch of Yartemlea, which is the first FDA-approved treatment for thrombotic microangiopathy associated with hematopoietic stem cell transplants [2][5] - The company has established dedicated billing and reimbursement codes and plans to introduce the YARTEMLE Assist patient support program by early 2026 [5] Clinical Performance - In pivotal trials, Yartemlea demonstrated a 100-day survival rate of 73% for patients suffering from TA-TMA [4] Market Position - Omeros holds a first-mover advantage in the TA-TMA treatment market, which positions the company strongly against competitors [7] - The company has a diverse pipeline, indicating potential for future success with additional treatments [7]

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?Omeros ( OMER ) stock surged sharply today, after the company announced the FDA approval of its drug candidate narsoplimab in the indication of hematopoietic stem cell transplant-associated thrombotic microangiopat ...