regulatory
confidence high
sentiment positive
materiality 0.60
Theriva Biologics receives FDA Fast Track Designation for VCN-01 in metastatic pancreatic cancer
Theriva Biologics, Inc.
- FDA granted Fast Track Designation for VCN-01 combined with gemcitabine/nab-paclitaxel for metastatic pancreatic adenocarcinoma.
- VCN-01 is being evaluated in the ongoing Phase 2b VIRAGE trial as first-line therapy for pancreatic ductal adenocarcinoma.
- Enrollment in VIRAGE expected to complete in Q3 2024.
- Previously, FDA granted orphan drug designation to VCN-01 for PDAC.