Will the FDA approve the personalized mRNA vaccine from Moderna/Merck for melanoma by December 31, 2027?
Current probability of “Yes”: 90%
- Status
- Open
- Category
- Science
- Closing date
- 5 January 2028
- Participants
- 2
VangAI analysis
VangAI edge: -5 pp
- Positive Phase 2b trial results demonstrated a significant reduction in the risk of recurrence or death with mRNA-4157/V940 combined with KEYTRUDA compared to KEYTRUDA alone.
- The FDA granted Breakthrough Therapy Designation for mRNA-4157/V940 combined with KEYTRUDA for adjuvant treatment of stage III/IV high-risk melanoma patients following complete resection.
- Moderna and Merck initiated Phase 3 studies in 2023, indicating progress in clinical development.
- The EMA granted PRIME designation for mRNA-4157/V940 combined with KEYTRUDA, highlighting the therapy's potential to address unmet medical needs.
Like a train that has passed most stations and is approaching the final one, but hasn't arrived yet.
Market rules
The market is resolved as YES if the U.S. Food and Drug Administration (FDA) officially approves (Approval, including accelerated approval) the personalized mRNA vaccine from Moderna (mRNA-4157/V940) in combination with Keytruda (pembrolizumab, Merck) for adjuvant therapy of high-risk melanoma recurrence by 11:59 PM UTC on December 31, 2027. The market is resolved as NO if approval has not been obtained by that date, including a Complete Response Letter, withdrawal of the application, or ongoing review. The submission of a BLA, Priority Review, positive advisory committee opinion, publication of trial results (including the announcement by Moderna and Merck on August 19, 2026, of the success of phase 3) and the stock performance of Moderna are not in themselves grounds for YES.