### Omeros Corporation Achieves Milestone with FDA Approval of YARTEMLEA for TA-TMA Omeros Corporation has made significant strides in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) with the recent FDA approval of YARTEMLEA (narsoplimab-wuug). This approval, announced on December 24, 2025, marks a pivotal moment as YARTEMLEA becomes the first and only therapy specifically indicated for this serious condition, which can arise following stem cell transplants. The drug is set to launch in the U.S. market on January 2, 2026, and Omeros plans to discuss the implications of this approval in a conference call scheduled for January 7, 2026 [https://www.tradingview.com/news/tradingview:983dee1fd9089:0-omeros-corp-announces-fda-approval-of-yartemlea-for-ta-tma, https://pharmashots.com/30469/omeros-receives-the-fda-approval-for-yartemlea-narsoplimab-wuug-to-treat-ta-tma]. ### Breakdown of the FDA Approval and Its Implications 1. **FDA Approval Announcement**: - Omeros Corporation announced the FDA approval of YARTEMLEA on December 24, 2025, highlighting its significance as the first approved treatment for TA-TMA [https://seekingalpha.com/news/4535069-omeros-wins-fda-nod-for-transplant-therapy]. 2. **Market Launch**: - The drug is expected to be available in the U.S. starting January 2, 2026, which positions Omeros to capitalize on the urgent need for effective treatments in this area [https://www.stocktitan.net/news/omer/omeros-announces-new-date-for-yartemlea-approval-conference-260fm3vy45r1.html]. 3. **Conference Call**: - A conference call is scheduled for January 7, 2026, to discuss the approval and its implications for patients and the company [https://www.wallstreet-online.de/nachricht/20315924-omeros-announces-new-date-for-yartemlea-approval-conference-call]. 4. **Stock Market Reaction**: - Following the announcement, Omeros' stock experienced a notable increase, reflecting investor confidence in the drug's potential market impact and revenue generation [https://seekingalpha.com/article/4855669-omeros-stock-pops-on-yartemlea-approval-longer-term-upside-likely]. ### Supporting Evidence and Market Context - **Efficacy of YARTEMLEA**: - YARTEMLEA has demonstrated a **61% success rate** in treating TA-TMA, a condition that can lead to severe complications post-transplant [https://www.benzinga.com/news/fda/25/12/49584558/fda-approves-omeros-first-in-class-drug-for-rare-transplant-complication]. - **Unique Positioning**: - As the only approved therapy for TA-TMA, YARTEMLEA fills a critical gap in treatment options, potentially benefiting a significant patient population [https://pharmaceuticaldaily.com/fda-approves-omeros-yartemlea-first-and-only-therapy-indicated-for-ta-tma]. ### Conclusion: A New Era for TA-TMA Treatment In summary, the FDA approval of YARTEMLEA represents a groundbreaking advancement in the treatment of TA-TMA, providing a much-needed therapeutic option for patients suffering from this serious condition. The upcoming market launch and the scheduled conference call will further elucidate the drug's potential impact on patient care and Omeros' business trajectory. 1. **FDA Approval**: YARTEMLEA is the first approved treatment for TA-TMA [https://seekingalpha.com/news/4535069-omeros-wins-fda-nod-for-transplant-therapy]. 2. **Market Launch**: Set for January 2, 2026, enhancing treatment accessibility [https://www.stocktitan.net/news/omer/omeros-announces-new-date-for-yartemlea-approval-conference-260fm3vy45r1.html]. 3. **Investor Confidence**: Stock prices surged post-announcement, indicating strong market interest [https://seekingalpha.com/article/4855669-omeros-stock-pops-on-yartemlea-approval-longer-term-upside-likely]. 4. **Efficacy Data**: YARTEMLEA shows a 61% success rate, underscoring its therapeutic value [https://www.benzinga.com/news/fda/25/12/49584558/fda-approves-omeros-first-in-class-drug-for-rare-transplant-complication].