Theriva Biologics shares surge 16.36% premarket after EMA backs Phase 3 trial design for VCN-01 in pancreatic cancer.

Theriva Biologics surged 16.36% in premarket trading following positive scientific advice from the European Medicines Agency (EMA) on its Phase 3 trial design for VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic pancreatic ductal adenocarcinoma (PDAC). The EMA endorsed key elements, including repeated dosing of VCN-01 in "macrocycles," an adaptive trial design, and alignment with primary/secondary endpoints. The regulator also acknowledged improved survival outcomes observed in prior trials, supporting a potential future marketing authorization application. Theriva plans an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the multinational Phase 3 trial protocol. The company’s $15.5 million cash runway through Q1 2027 further bolstered investor confidence, as it supports regulatory, protocol, and partnership activities for pivotal trials in PDAC and retinoblastoma.