Omeros 的 narsoplimab(YARTEMLEA) 在欧洲复审后再遭 CHMP 否定，欧洲上市路径基本关闭，盘前跌约5%

Omeros Corporation (OMER) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on the company's marketing authorization application for narsoplimab following a re-examination of its original negative decision from June 2026.
Narsoplimab is marketed in the United States under the brand name YARTEMLEA and is approved by the U.S. FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in patients aged two years and older. According to Omeros, it is currently the only approved therapy for TA-TMA.
TA-TMA is a serious and potentially life-threatening complicaiton that can develop following hematopoietic stem cell transplantation. The condition can cause damage to small blood vessels and is associated with high mortality rates in severe cases.
As part of the European re-examination process, the CHMP convened an ad hoc expert group consisting of hematologists, statisticians, transplant physicians and patient representatives. According to Omeros, the expert group recommended a review of individual patient-level data to better understand factors associated with treatment response and survival.
The company said it had submitted substantial patient-level data during the re-examination process but noted that CHMP ultimately maintained its negative opinion on the application.
Omeros stated that it remains committed to expanding access to YARTEMLEA outside the United States and is working to support reimbursed named-patient access where permitted in Europe and other regions.
The company also announced that due to increasing commercial demand for YARTEMLEA in the United States, it intends to discontinue its compassionate-use program, although currently treated patients will continue to receive sufficient drug to complete their treatment courses.
Beyond TA-TMA, Omeros is advancing additional programs within its MASP-2 franchise, including the long-acting antibody OMS1029 and oral small-molecule inhibitors. Clinical studies in acute respiratory distress syndrome (ARDS) and prevention of high-risk TA-TMA in pediatric patients are expected to begin later this year.
OMER has traded between $6.24 and $21.24 over the past year. The stock closed Thursday's trading at $18.79, up 1.95%. In pre-market trading the stock is at $17.84, down 5.04%.
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