Shares of Theriva Biologics, Inc., trading under ticker symbol TOVX on the New York Stock Exchange, rose noticeably on Monday, accompanied by a trading volume of approximately 114.18 million shares, a substantial increase compared to the average daily volume of 15.61 million shares, based on data provided by Benzinga Pro. This upward movement coincided with the release of news that the company had obtained Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA). This advice pertains to the design framework of the planned Phase 3 clinical trial for Theriva's leading investigational candidate, VCN-01.
The future Phase 3 trial, as guided by the CHMP, intends to assess the efficacy and safety of VCN-01 in conjunction with the established gemcitabine and nab-paclitaxel chemotherapy regimen, which currently constitutes the standard of care (SoC) for patients receiving first-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC). The EMA's Scientific Advice appears to endorse the company’s proposed clinical approach and development strategy for VCN-01 in this patient population.
Theriva has previously disclosed results from its Phase 2 VIRAGE trial, which evaluated VCN-01 combined with gemcitabine and nab-paclitaxel SoC versus the SoC chemotherapy alone. Data from this study demonstrated that patients treated with the VCN-01 combination exhibited improvements in overall survival (OS), progression-free survival (PFS), and duration of response compared to those receiving chemotherapy alone. Notably, patients who underwent two doses of VCN-01 spaced three months apart experienced even greater enhancements across these clinical endpoints.
The CHMP's scientific review acknowledged the clinical benefits observed in the VIRAGE study, especially highlighting the enhanced overall survival among patients administered two VCN-01 doses. They concurred with the dosing strategy proposed by Theriva involving repeated "macrocycles," enabling the administration of more than two doses of VCN-01 during the Phase 3 study. Additionally, the committee suggested that more frequent dosing of VCN-01 could also be explored as part of the trial design.
Regarding regulatory pathways, the CHMP indicated that a prospective marketing authorization application (MAA) for VCN-01 in metastatic PDAC could be substantiated by the clinical development plan, provided that the Phase 3 trial substantiates a compelling benefit-risk profile for the VCN-01 and gemcitabine/nab-paclitaxel combination over SoC chemotherapy alone.
Financially, Theriva reported holding $15.5 million in cash and cash equivalents as of November 10, 2025. This cash reserve is projected to support operations and key activities well into the first quarter of 2027. This timeline aligns with the company’s plans to continue interactions with regulatory authorities concerning both the pancreatic cancer and retinoblastoma initiatives. Theriva also intends to advance partnerships aimed at scaling up manufacturing capacity for VCN-01 and executing the proposed pivotal clinical trials.
Market data at the time of publication indicated that TOVX shares were trading at $0.19, reflecting a 4.03% increase. The rise in price coupled with significantly elevated volume demonstrates increased investor attention in response to the regulatory developments surrounding VCN-01.
As Theriva progresses, the critical milestones will center on executing the Phase 3 trial according to the EMA's guidance and validating the clinical benefit observed in earlier studies. Successful demonstration of efficacy and safety in metastatic PDAC could pave the way toward potential regulatory approval, while the company's cash position and upcoming partnerships will be vital to sustaining this development trajectory.