Sell-Side Analysts Published Tuesday August 25, 2026 Projections That Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) Intismeran Autogene (V940 / mRNA-4157, the Individualized Neoantigen Therapy That Encodes Up to 34 Tumor-Specific Neoantigen Peptides From Each Individual Patient's Tumor Mutation Signature Delivered as a Lipid Nanoparticle mRNA Injection) Will Exceed $1 Billion in Annual Sales by 2031 Following the August 19 Positive Phase 3 INTerpath-001 Melanoma Readout That Met the Primary Endpoint of Recurrence-Free Survival and Key Secondary Endpoint of Distant Metastasis-Free Survival in Adults With Completely Resected Stage IIB-IV Melanoma; The Sales Trajectory Assumes Approvals Across Additional Adjuvant Indications Currently in Phase 3 Development Including Non-Small-Cell Lung Cancer, Renal Cell Carcinoma, and Cutaneous Squamous Cell Carcinoma
Sell-side analysts published Tuesday August 25, 2026 projections that Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) intismeran autogene (V940 / mRNA-4157) will exceed $1 billion in annual sales by 2031 following the August 19 positive Phase 3 INTerpath-001 melanoma readout. Product context: intismeran autogene is an individualized neoantigen therapy that uses each individual patient's tumor mutation signature to design a personalized mRNA vaccine encoding up to 34 tumor-specific neoantigen peptides. The mRNA is delivered as a lipid nanoparticle injection; cells at the injection site translate the mRNA into the neoantigen peptides, which are then presented to the immune system to generate a targeted T-cell response against the patient's tumor. The INTerpath-001 Phase 3 trial met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival in adults with completely resected Stage IIB-IV cutaneous melanoma. The $1+ billion 2031 sales trajectory assumes approvals across additional adjuvant indications currently in Phase 3 development including non-small-cell lung cancer (INTerpath-002), renal cell carcinoma (INTerpath-003), and cutaneous squamous cell carcinoma (INTerpath-005). Manufacturing scale-up remains a substantial commercial constraint because each patient dose requires an individualized manufacturing run driven by that patient's tumor sequence, unlike traditional off-the-shelf drugs; Moderna is investing in automated manufacturing infrastructure to support the projected launch volumes. The sales trajectory reset materially resets investor expectations about the personalized neoantigen therapy modality that had traded largely on Phase 2 data until the August 19 confirmatory Phase 3 result.