Theriva Biologics receives EMA approval for VCN-01 Phase 3 trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 12 2025
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Should l Buy TOVX?
Theriva Biologics Inc's stock is down 5.28% in pre-market trading, crossing below the 20-day SMA, despite the Nasdaq-100 rising 0.98% and the S&P 500 gaining 0.56%.
The decline comes amid the company's recent announcement of receiving EMA approval for the Phase 3 trial design of VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic pancreatic cancer. This approval is expected to significantly enhance patient survival and treatment outcomes, providing a strong foundation for future growth. However, the stock's movement suggests sector rotation as investors reassess their positions in light of the broader market gains.
This EMA approval marks a critical step for Theriva, as it not only validates the potential of VCN-01 but also ensures the company has sufficient funding to support its clinical trials until 2027, thereby strengthening its competitive position in the oncology market.
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About TOVX
Theriva Biologics, Inc. is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform. The Company’s candidates are VCN-01, SYN-004 (ribaxamase) and SYN-020. VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a physical and immunosuppressive barrier to cancer treatment; SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci), and SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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Theriva Biologics Receives EMA Support for Phase 3 Trial of VCN-01
- Strong Stock Performance: Theriva Biologics' stock rose 4.03% on Monday with a trading volume of 114.18 million shares, significantly exceeding the average volume of 15.61 million shares, indicating positive market sentiment regarding its clinical advancements.
- Clinical Trial Design Approved: The company received Scientific Advice from the EMA's Committee for Medicinal Products for Human Use, supporting its Phase 3 trial design for VCN-01, aimed at evaluating its efficacy in combination with standard chemotherapy, potentially offering new treatment options for pancreatic cancer patients.
- Survival Rate Improvement: In the previous VIRAGE Phase 2 trial, patients treated with VCN-01 in combination with standard chemotherapy demonstrated higher overall survival and progression-free survival rates, particularly those receiving two doses of VCN-01, further validating the drug's potential efficacy.
- Healthy Cash Position: As of November 10, 2025, Theriva had $15.5 million in cash and equivalents, providing a runway into the first quarter of 2027, facilitating interactions with regulatory agencies and scaling up VCN-01 manufacturing.
See More
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- Trial Design Approval: Theriva has received EMA approval for the Phase 3 trial design of VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic PDAC, which is expected to significantly enhance patient survival and treatment outcomes.
- Funding Runway Until 2027: Theriva's cash reserves are projected to last until Q1 2027, ensuring the company can complete regulatory activities and trial designs, thereby strengthening its competitive position in cancer treatment.
- FDA Meeting Scheduled: Theriva plans to hold an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of the Phase 3 trial, further advancing VCN-01's path to market.
- Potential of Multi-Dose Regimen: EMA acknowledged the significant survival improvement in patients receiving two doses of VCN-01 in the VIRAGE study, and Theriva plans to explore the application of three or more doses in the Phase 3 trial to achieve even better therapeutic outcomes.
See More
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- Trial Design Approval: Theriva has received scientific advice from the EMA regarding the Phase 3 trial design for VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic PDAC, marking a significant advancement in cancer treatment.
- Survival Rate Improvement: The VIRAGE Phase 2 trial demonstrated that patients receiving two doses of VCN-01 exhibited higher overall survival and progression-free survival, indicating the drug's potential in treating metastatic pancreatic cancer.
- Financial Support: Theriva anticipates having $15.5 million in cash reserves until Q1 2027, which will support regulatory activities and clinical trial execution, ensuring financial stability during critical phases.
- Future Planning: The company plans to hold an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of the Phase 3 trial, aiming to provide innovative treatment options for patients and further enhance its strategic positioning in cancer therapy.
See More
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