regulatory
confidence high
sentiment positive
materiality 0.75
Theriva Biologics obtains FDA agreement on Phase 3 trial design for VCN-01 in metastatic PDAC
Theriva Biologics, Inc.
- FDA provided general agreement on proposed Phase 3 trial design for VCN-01 plus gemcitabine/nab-paclitaxel.
- Phase 3 trial will track successful VIRAGE Phase 2 design with repeat dosing and adaptive elements.
- FDA agreed on primary endpoint (OS), key secondary endpoints, inclusion/exclusion criteria, and dosing schedule.
- Consistent with prior EMA advice; company to finalize protocol and pursue funding or partnerships.
- VIRAGE Phase 2 met primary endpoints; improved OS, PFS, DoR for VCN-01 plus SoC vs SoC alone in metastatic PDAC.