Theriva™ Biologics Announces Positive Scientific Advice from the European Medicines Agency (EMA) on the Design of a Phase 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma (...
Theriva Biologics, Inc. (TOVX)
Company Research
Source: GlobeNewswire
- EMA provided overall agreement with the proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC, including sample size, repeated dosing of VCN-01, and an adaptive design to potentially optimize trial timelines and outcomes - - Theriva to schedule an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of a pivotal multinational Phase 3 clinical trial - - Theriva’s cash runway until Q1 2027 supports completion of regulatory activities, protocol development, and partnering activities to support proposed pivotal trials of VCN-01 in metastatic PDAC and retinoblastoma - ROCKVILLE, Md., Dec. 29, 2025 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the receipt of Scientific Advice from the Committee for Medicinal Products fo
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Sec Filings
- 1/12/26 - Form 8-K
- 1/6/26 - Form 4
- 1/6/26 - Form 4
- TOVX's page on the SEC website