Record mula sa primary source
Decision-gradeOpinyon ng EMA
Nakatanggap ang Moderna ng pag-apruba mula sa EU para sa mNEXSPIKE at mCOMBRIAX
Nakasaad sa dokumento na binigyan ng European Commission ng marketing authorization ang mNEXSPIKE at ang flu-plus-COVID combination vaccine na mCOMBRIAX, na siyang unang pag-apruba ng ganitong uri sa buong mundo. Binabago nito ang regulatory path mula sa pending review patungo sa approved status sa EU, nagdaragdag ng dalawang commercial products sa portfolio ng Moderna at nagbibigay-daan sa agarang market access sa Europe.
Mahahalagang fact
- Na-file
- May 1, 2026, 10:32 AM
- Kaganapan
- Opinyon ng EMA
- Direksyon
- Positibo
- Kumpanya
MRNAModerna- Asset
- mNEXSPIKE
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
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