The FDA approved what is described as the first DNA plasmid immunotherapy, moving the New Molecular Entity (NME) tally to 47 for the year-to-date period. The approval is positioned as another step in expanding immunotherapy formats beyond conventional viral vectors and mRNA platforms. The timing is part of a broader wave of October approvals that the industry is using to forecast 2026’s total NME count through the remaining months. The DNA plasmid category has been under development for years, with the key differentiator being the delivery of genetic material that can be expressed in vivo. For biotech leaders, the decision adds a regulatory benchmark for manufacturing, characterization, and clinical evidence expectations for DNA-based immunotherapeutics.