Theriva Biologics receives EMA approval for VCN-01 Phase 3 trial

Written by Emily J. Thompson, Senior Investment Analyst

Updated: 02 Jan 26

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.

TOVX

$0.1865+Infinity%1D

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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.

Theriva Biologics receives EMA approval for VCN-01 Phase 3 trial

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