**Positive Phase 3 results from Moderna and Merck’s INTerpath-001 trial for intismeran autogene (mRNA-4157/V940), announced in August 2026, form the main driver of trader sentiment on the BLA submission timeline.** The individualized neoantigen mRNA vaccine plus pembrolizumab met primary endpoints for recurrence-free survival and distant metastasis-free survival in resected high-risk cutaneous melanoma, marking the first such readout for this approach and building on earlier Phase 2 risk reductions of roughly 49%. The companies stated plans to present detailed data at an upcoming medical meeting and engage regulators on potential filings. With breakthrough therapy designation and precedent for accelerated reviews in melanoma, this positions a 2027 submission as the consensus path, though full data review, manufacturing scale-up, and any additional FDA feedback remain key variables that could shift timelines.