原始来源记录
决策级EMA 意见
Moderna 获得欧盟对 mNEXSPIKE 和 mCOMBRIAX 的批准
文件显示，欧盟委员会已授予 mNEXSPIKE 及流感加新冠组合疫苗 mCOMBRIAX 的上市许可，这是全球首个此类组合疫苗批准。此举将监管路径从待审状态转为欧盟已批准状态，为 Moderna 产品组合新增两款商业化产品，并使其能够立即进入欧洲市场。
关键事实
来源摘录
EX-99.1 2 exhibit9912026q1pressrelea.htm EX-99.1 Document Exhibit 99.1 Moderna Reports First Quarter 2026 Financial Results and Provides Business Updates Reports first quarter revenue of $0.4 billion, with approximately 80% of revenue from international markets Reports first quarter GAAP net loss of $(1.3) billion and GAAP EPS of $(3.40), including $0.9 billion non-recurring litigation settlement charge Reiterates plan to deliver up to 10% revenue growth and GAAP operating expense reductions in 2026, excluding the non-recurring litigation settlement charge Advanced infectious disease portfolio with key regulatory milestones in the EU, including approval of mNEXSPIKE and mCOMBRIAX, Moderna’s flu plus COVID combination vaccine Initiated Phase 3 clinical study evaluating intismeran au