Catatan sumber primer
PenentuOpini EMA
Moderna menerima persetujuan UE untuk mNEXSPIKE dan mCOMBRIAX
Dokumen tersebut menyatakan bahwa Komisi Eropa memberikan otorisasi pemasaran untuk mNEXSPIKE dan vaksin kombinasi flu-plus-COVID mCOMBRIAX, menandai persetujuan kombinasi pertama di dunia. Hal ini mengubah jalur regulasi dari tinjauan tertunda menjadi status disetujui di UE, menambahkan dua produk komersial ke portofolio Moderna dan memungkinkan akses pasar langsung di Eropa.
Fakta utama
- Diajukan
- 1 Mei 2026, 10.32
- Peristiwa
- Opini EMA
- Arah
- Positif
- Perusahaan
MRNAModerna- Aset
- mNEXSPIKE
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
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