MRNA · 8-K · 20260731PR000147
Regulatory Approval Milestones
Moderna, Inc. · 2026-07-31 · Importance 44 · Surprise 60 · In source text
Moderna received European Commission marketing authorization for the mCOMBRIAX seasonal flu and COVID combination vaccine. Regulatory filings for mRNA-1083 are under review in Japan, Canada and Australia, while mRNA-1010 filings are under review in Europe, Canada and Australia. Moderna’s mFLUSIVA seasonal influenza vaccine received a unanimous VRBPAC recommendation ahead of its August 5 U.S. PDUFA date, and mRNA-1010 also has an August 5 U.S. PDUFA date. The company additionally received mRESVIA approvals in Australia and Mexico and mNEXSPIKE approvals in Japan and Taiwan.
Key facts
- The Company anticipates potential approval of mFLUSIVA with the August 5th PDUFA date. source
- The U.S. FDA has assigned a PDUFA date for mRNA-1010 of August 5, 2026. source
- Moderna received a unanimous recommendation from the VRBPAC for mFLUSIVA ahead of an August 5 PDUFA goal date in the U.S. source
- Moderna has received European Commission marketing authorization for mCOMBRIAX in the EU. source
- Moderna received regulatory approvals in Australia and Mexico for mRESVIA. source
- Moderna received regulatory approvals in Japan and Taiwan for mNEXSPIKE. source
- Moderna's mRNA-1010 regulatory filings are under review in Europe, Canada and Australia and potential approvals are expected to begin in 2026. source
- Moderna's mRNA-1083 regulatory filings are under review in Japan, Canada and Australia. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | contingent | — | The Company anticipates potential approval of mFLUSIVA with the August 5th PDUFA date. |
| revenue | positive | contingent | — | The U.S. FDA has assigned a PDUFA date for mRNA-1010 of August 5, 2026. |
| revenue | positive | probable | — | Moderna received a unanimous recommendation from the VRBPAC for mFLUSIVA ahead of an August 5 PDUFA goal date in the U.S. |
| revenue | positive | committed | — | Moderna has received European Commission marketing authorization for mCOMBRIAX in the EU. |
| revenue | positive | committed | — | Moderna received regulatory approvals in Australia and Mexico for mRESVIA. |
| revenue | positive | committed | — | Moderna received regulatory approvals in Japan and Taiwan for mNEXSPIKE. |
| revenue | positive | probable | — | Moderna's mRNA-1010 regulatory filings are under review in Europe, Canada and Australia and potential approvals are expected to begin in… |
| revenue | positive | probable | — | Moderna's mRNA-1083 regulatory filings are under review in Japan, Canada and Australia. |