- Skin cancer vaccine BLA submitted by June 30, 2027?79¢
This market will resolve to "Yes" if it is officially announced that a Biologics License Application (BLA) for intismeran autogene has been submitted to the U.S. Food and Drug Administration (FDA), or that the FDA has accepted such an application for review, by June 30, 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. A qualifying application must seek FDA licensure of intismeran autogene through a Biologics License Application (BLA). An original BLA or a resubmission of such a BLA following FDA action will qualify. The application may cover any indication. A qualifying announcement must come from the relevant company submitting the BLA, the FDA, or authorized representatives thereof. The submission must already have occurred at the time of the statement. A statement of intent, plan, guidance, or expected timing will not qualify. If the FDA grants approval of intismeran autogene on or before June 30, 2027, 11:59 PM ET, this market will resolve to "Yes", whether or not a submission was separately disclosed. The primary resolution source for this market will be official communications from the company submitting the BLA, the FDA, or authorized representatives thereof; however, a consensus of credible reporting may also be used.
Recent positive Phase 3 results for Moderna and Merck’s personalized mRNA vaccine intismeran (mRNA-4157) in high-risk melanoma, announced August 19, 2026, represent the key catalyst behind the 86.5% implied probability. The trial met its primary endpoint of recurrence-free survival and a key secondary endpoint for distant metastasis-free survival, building on sustained five-year Phase 2 data showing a 49% risk reduction. With breakthrough therapy designation already granted, the fully enrolled Phase 3 program, and ongoing regulatory discussions, the companies have signaled plans to submit a BLA in the coming months. This timeline comfortably precedes the June 2027 deadline, though final submission hinges on data maturity and FDA alignment.