- Skin cancer vaccine FDA approved by December 31, 2027?73¢
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants approval of intismeran autogene for any indication by December 31, 2027, 11:59 PM ET. Otherwise, this market will resolve to "No". Intismeran autogene refers to the individualized neoantigen therapy developed by Moderna and Merck and evaluated in the Phase 3 INTerpath-001 trial (NCT05933577), also known as mRNA-4157 and V940, together with any brand, trade, or nonproprietary name later assigned to that product, as well as any renamed or modified version that the relevant company or the FDA identify as the same product or a direct continuation of the V940/mRNA-4157 program. Differences in neoantigen composition between patients will not affect resolution. Changes to the product's formulation will not affect resolution, provided the FDA approves the product described above. Approval as part of a combination regimen will qualify. Approval for a narrower population than the one studied in INTerpath-001 will qualify. Approval for an indication other than melanoma will also qualify. Both standard and accelerated approval will qualify. An approval is defined as: For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA) For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA) For biosimilars: FDA approval of a 351(k) application The following constitute qualifying approvals: Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs The following do not constitute qualifying approvals: Approvable letters that require additional actions before approval Tentative approvals pending patent or exclusivity expiration FDA requests for additional information or studies Extension of Prescription Drug User Fee Act (PDUFA) dates Approval for compassionate use or expanded access programs only Approval only for export or for use outside the United States Emergency Use Authorization (EUA) without full approval Complete Response Letters (CRLs) indicating the application cannot be approved in its current form If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval. Conditional approvals may include post-marketing requirements or commitments and still qualify. The primary resolution source for this market will be official information from the FDA; however, a consensus of credible reporting may also be used.
Positive long-term data from Moderna and Merck’s personalized mRNA melanoma vaccine (intismeran autogene/mRNA-4157/V940) combined with Keytruda, plus an ongoing Phase 3 trial, underpin the 72.5% market-implied odds for FDA approval by December 31, 2027. In January 2026, the companies reported five-year Phase 2b follow-up results showing the combination sustained a 49% reduction in recurrence or death risk versus Keytruda alone in high-risk resected melanoma, with consistent benefits on distant metastasis-free survival. These findings, presented at ASCO 2026 in June, reinforced the individualized neoantigen therapy approach using mRNA technology similar to COVID-19 vaccines. The global Phase 3 trial (V940-001/INTerpath-001) is fully enrolled with nearly 1,000 patients; analysts note potential interim readouts or data analyses in late 2026 that could support a regulatory filing. Breakthrough Therapy Designation and the oncology regulatory pathway create scope for accelerated review once pivotal data are available, aligning with credible estimates of possible approval by late 2027 or early 2028 if Phase 3 confirms benefit. Supporting momentum comes from Scancell’s DNA vaccine (iSCIB1+) receiving FDA fast-track and IND clearance for a registrational Phase 3 in advanced melanoma starting in the second half of 2026. Traders weigh the strong clinical signals and compressed timelines against typical Phase 3 readout and review durations, creating a clear but not overwhelming consensus around approval within the window. Key near-term catalysts include additional Phase 3 updates and any FDA interactions on endpoints or expedited pathways.