Theriva Biologics, Inc. (TOVX) shares jumped Monday on news that should make investors in the biotech space perk up. The company received Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency, essentially getting a regulatory roadmap for its Phase 3 trial of VCN-01, a treatment targeting metastatic pancreatic ductal adenocarcinoma.
The trading action told the story before anything else. Volume hit 114.18 million shares, absolutely dwarfing the average daily volume of 15.61 million. When a small biotech sees volume spike like that, something meaningful is happening.
What VCN-01 Actually Does
The planned Phase 3 trial will test VCN-01 combined with gemcitabine/nab-paclitaxel, the standard-of-care chemotherapy regimen, for first-line treatment of metastatic pancreatic ductal adenocarcinoma. Pancreatic cancer is notoriously difficult to treat, so any potential improvement in outcomes draws attention from both the medical community and investors.
The Phase 2 Results That Got Everyone Excited
Here's why European regulators are taking this seriously. Theriva previously reported results from its VIRAGE Phase 2 trial, and the data looked promising. Patients who received VCN-01 plus the standard gemcitabine/nab-paclitaxel chemotherapy showed increased overall survival, progression-free survival, and duration of response compared to patients who received the standard chemotherapy alone.
The really interesting finding: patients who received two doses of VCN-01 administered three months apart showed even greater improvements across these survival metrics.
What the Regulators Actually Said
The CHMP's advice is essentially regulatory encouragement. They indicated that a future marketing authorization application for VCN-01 in metastatic pancreatic cancer could be supported by Theriva's proposed clinical development strategy, assuming the Phase 3 trial demonstrates a compelling benefit-risk ratio compared to standard chemotherapy alone.
The regulators specifically recognized that increased improvement in overall survival seen in patients receiving two doses of VCN-01 in the VIRAGE study. They agreed with the proposed dosing approach using repeated "macrocycles," which would allow more than two doses of VCN-01 to be administered during the Phase 3 trial. They even suggested that more frequent dosing could be considered, which is regulatory speak for "we're open to this being even more aggressive if the data supports it."
The Money Question
As of November 10, 2025, Theriva reported having $15.5 million in cash and equivalents. The company projects this provides runway into the first quarter of 2027 as it completes interactions with regulatory agencies regarding both its pancreatic cancer and retinoblastoma programs and pursues partnerships to support VCN-01 manufacturing scale-up and conduct of the proposed pivotal clinical trials.
That's not exactly a war chest, which means partnerships will be critical. Running a Phase 3 oncology trial isn't cheap, and the company will need either partnership dollars or additional capital raises to get this across the finish line.
Price Action: Theriva Biologics shares were up 4.03% at $0.19 at the time of publication on Monday.