$Theriva Biologics (TOVX.US)$ NEWS Theriva™ Biologics Announ...
NEWS
Theriva™ Biologics Announces Fast Track Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Metastatic Pancreatic Cancer
Theriva Biologics (NYSE American: TOVX) announced that the U.S. FDA granted Fast Track Designation (FTD) to its clinical candidate VCN-01 for treating metastatic pancreatic cancer. This designation aims to expedite the drug's development and review process. VCN-01, combined with gemcitabine and nab-paclitaxel, is undergoing a Phase 2b clinical study (VIRAGE) to evaluate its effectiveness as a first-line therapy for pancreatic ductal adenocarcinoma (PDAC). The FDA had previously given orphan drug status to VCN-01 for PDAC. The ongoing VIRAGE trial is expected to complete enrollment by Q3 2024. FTD allows for early and frequent FDA interactions and could speed up the approval process if certain criteria are met.
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