Theriva: FDA Grants Fast Track Designation To Lead Clinical Candidate VCN-01

(RTTNews) - Theriva Biologics (TOVX) announced the FDA has granted Fast Track Designation to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. Previously, the FDA granted orphan drug designation to VCN-01.

Steven Shallcross, CEO of Theriva Biologics, said: "VIRAGE, our Phase 2b trial evaluating VCN-01 in metastatic PDAC continues to progress, with enrollment expected to complete in the third quarter of 2024."

Shares of Theriva Biologics are up 30% in pre-market trade on Thursday.

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