Investing.com -- Theriva Biologics Inc (NYSE American:TOVX) stock surged 25.4% in Monday premarket trading after the company announced receiving positive scientific advice from the European Medicines Agency (EMA) regarding its proposed Phase 3 clinical trial design for VCN-01 in pancreatic cancer treatment.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) provided overall agreement with Theriva’s proposed pivotal trial of VCN-01 in combination with standard chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC). The regulatory body endorsed key elements including sample size, repeated dosing of VCN-01, and an adaptive design approach.
Importantly, the EMA recognized the improved survival outcomes observed in patients who received multiple doses of VCN-01 in earlier trials and agreed with Theriva’s proposed "macrocycle" dosing regimen that would allow for more than two doses in the Phase 3 trial.
"We are very encouraged by the scientific advice we received from the EMA regarding our proposed pivotal Phase 3 trial of VCN-01 plus gemcitabine/nab-paclitaxel SoC in metastatic PDAC patients," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.
The company plans to schedule an End-of-Phase 2 meeting with the FDA in the first half of 2026 to finalize the protocol for a multinational Phase 3 trial. Theriva is also seeking regulatory advice on a potential Phase 2/3 trial for VCN-01 in retinoblastoma, a rare childhood cancer.
Theriva reported having $15.5 million in cash and equivalents as of November 10, 2025, providing runway into the first quarter of 2027 as it completes regulatory interactions and pursues partnerships to support manufacturing scale-up and conduct of proposed pivotal trials.
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