Feb. 4 at 10:56 AM
$TOVX Theriva Biologics (NYSE:TOVX) received scientific advice from the EMA CHMP on a proposed, double-blind, randomised, placebo-controlled phase 3 study of VCN-01 plus gemcitabine/nab-paclitaxel as the first-line for metastatic pancreatic oductal cancer (PDAC).
CHMP agreed on the overall survival outcome as the primary endpoint, important secondary endpoints, inclusion/exclusion criteria, sample size and adaptive design. CHMP supported repeated “macrocycle” doses (> two doses) following positive signs of VIRAGE Phase 2b. Theriva plans an FDA End-of-Phase 2 meeting in the first half of 2026. The liquidity of
$15.5 million offers a prospect until Q1 2027 to complete regulatory and partnership activities.
