Theriva Biologics Addresses Uncommon Market Activity
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 24 2025
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Should l Buy TOVX?
Source: Newsfilter
Unusual Trading Activity: Theriva Biologics reported unusual trading activity in its common stock on October 24, 2025, but found no material developments or reasons for the market action.
VIRAGE Trial Presentation: The company recently presented expanded data from its VIRAGE trial investigating VCN-01 at the ESMO 2025 Annual Congress on October 13, 2025.
Company Overview: Theriva Biologics is a clinical-stage company focused on developing cancer therapeutics, including oncolytic adenoviruses and other treatments aimed at improving patient outcomes.
Lead Candidates: The company's lead candidates include VCN-01, SYN-004, and SYN-020, each targeting different aspects of cancer treatment and microbiome protection.
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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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- 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.
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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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