Data updated: Nov 8, 2026
mnexspike (covid-19 vaccine, mrna) · Moderna
Approved 2025-05-30
1
Indication
--
Phase 3 Trials
1
Years on Market
Details
- Status
- Prescription
- First Approved
- 2025-05-30
- Revenue
- $91M (Q2-2026) combined: Spikevax + mNEXSPIKE
- Routes
- Intramuscular
- Dosage Forms
- Injection
mnexspike Approval History
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
May 2025 ORIGINAL
Update · CBER biologic (Purple Book)
What mnexspike Treats
1 FDA approvalsOriginally approved for its first indication in 2025 .
- Other (1)
Other
(1 approval)- • Approved indication (May 2025)
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
mnexspike FDA Label Details
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Revenue Insights
- • Q2-2026: $91M (combined: Spikevax + mNEXSPIKE)
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.