Theriva Biologics (TOVX), Wednesday reported positive topline results from the VIRAGE Phase 2b study evaluating the company's lead drug candidate VCN-01 plus standard-of-care chemotherapy gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
The study met its primary safety endpoint as VCN-01 was well-tolerated, with transient and reversible adverse events. The company's shares were more than 45% up in pre-market.
In the study, 96 newly-diagnosed metastatic PDAC patients were randomized to receive either VCN-01 plus standard-of-care gemcitabine/nab-paclitaxel or gemcitabine/nab-paclitaxel alone.
Data from the study showed that 48 patients treated with at least one dose of gemcitabine/nab-paclitaxel had a median overall survival (OS) of 8.6 months, while the 48 patients treated with VCN-01 followed by at least one dose of gemcitabine/nab-paclitaxel SoC had a median OS of 10.8 months. Median progression free survival (PFS) was 7 months for the VCN-01+SoC treatment arm versus 7 months for SoC control arm. Further, the increase in OS was greater for patients who received 2 doses of VCN-01.
"These data, combined with recent advice from the U.S. FDA and the European Medical Agency, are expected to facilitate engagement with industry partners and enable the design of a Phase 3 confirmatory trial that, if successful, may deliver an important new therapeutic option for patients suffering this rapidly fatal disease," the company said in a statement.
VCN-01 has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
Theriva Biologics stock had closed at $1.36, down 2.51% on Tuesday. It has traded in the range of $0.96 - $12.25 in the last 1 year.
For comments and feedback contact: editorial@rttnews.com
Business News
April 10, 2026 16:21 ET Inflation data from the U.S. was the main data event this week as the conflict in the Middle East continue. The minutes of the latest Fed policy session and the survey data on the services sector also made headlines. In Europe, manufacturing orders data from Germany was in focus. Price data from China drew attention in Asia.