Theriva Biologics Announces EMA Advice on Phase 3 Trial for VCN-01
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Theriva Biologics announced that it received EMA advice on the Phase 3 trial design for VCN-01 in metastatic PDAC. The EMA agrees with the trial design, which includes an adaptive approach to optimize timelines and outcomes. Theriva plans to meet with the FDA in H1 2026 to finalize the trial design. The company's cash runway supports regulatory and partnering activities until Q1 2027. VCN-01 has been granted Orphan Drug and Fast Track designations in both the US and Europe.
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