Theriva Biologics shares surge 16.58% after-hours after receiving CHMP scientific advice on VCN-01 Phase 3 design.

Theriva Biologics (TOVX) surged 16.58% in after-hours trading following the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) providing scientific advice on its VCN-01 Phase 3 trial design for metastatic pancreatic ductal adenocarcinoma (PDAC). The CHMP endorsed the proposed trial structure, including inclusion/exclusion criteria, endpoints, and a dosing regimen allowing multiple VCN-01 administrations, aligning with the company’s strategy to demonstrate a compelling benefit-risk ratio. VCN-01, which has Orphan Drug and Fast Track designations, showed improved survival metrics in its Phase 2b trial, and the CHMP’s recognition of these data, alongside approval of an adaptive trial design, signals regulatory support for a potential future marketing application. The company also noted sufficient cash reserves ($15.5M as of November 2025) to fund operations through Q1 2027, further reinforcing investor confidence in its development timeline and partnership prospects.