**The August 2026 Phase 3 INTerpath-001 readout for Moderna and Merck’s individualized mRNA neoantigen vaccine intismeran autogene (V940/mRNA-4157) plus Keytruda is the dominant driver of trader sentiment.** The trial met its primary recurrence-free survival endpoint and key secondary distant metastasis-free survival endpoint in resected high-risk stage IIB–IV cutaneous melanoma—the first positive late-stage result for any mRNA cancer vaccine or personalized neoantigen therapy. Companies are preparing full data for an upcoming medical meeting (likely ESMO) and have begun regulatory engagement, though no BLA filing has occurred and detailed numbers remain undisclosed. Other skin-cancer candidates, such as Scancell’s DNA plasmid vaccine, remain earlier in development with only IND clearance for Phase 3. Recent FDA approvals in melanoma and cutaneous squamous cell carcinoma involve oncolytic viruses or PD-1 inhibitors rather than vaccines, underscoring the distinct regulatory bar for this novel personalized modality. Approval timelines hinge on submission speed, data maturity (including overall survival), and FDA review under breakthrough therapy designation, with realistic scenarios for slippage or additional requirements.