Core Insights - Omeros Corporation received FDA approval for YARTEMLEA (narsoplimab-wuug) to treat thrombotic microangiopathy associated with hematopoietic stem cell transplants, marking it as the first and only therapy for this condition [2][4] Company Developments - YARTEMLEA functions by inhibiting MASP-2, a crucial enzyme in the lectin complement pathway, thus preventing its activation while preserving other immune defense mechanisms [3] - The approval was based on a clinical study involving 28 adult patients and an expanded access program with 221 patients, both of whom were high-risk TA-TMA patients [3] - The FDA approval is seen as a significant milestone for Omeros, transitioning the company from a development stage to a revenue-generating entity, with U.S. market launch planned for January 2026 [4][6] - Omeros has reported strong clinical results, with complete response rates of 61% in the main study and 68% in the expanded access program, alongside improved survival rates [10][11] Market Position and Financials - Following the announcement, Omeros shares increased by 2.3%, and the stock has surged 423.7% over the past six months, significantly outperforming the industry and S&P 500 [5] - The company currently has a market capitalization of $1.11 billion, positioning it favorably within the biotechnology sector [9] Future Prospects - The approval of YARTEMLEA establishes Omeros as a leader in the treatment of TA-TMA, providing a first-mover advantage in the orphan drug market [12] - The stem cell therapy market is projected to reach $6.75 billion by 2025, with a CAGR of 12.6% through 2034, driven by the increasing prevalence of chronic diseases [13]