Theriva Biologics Gains EMA Backing for VCN-01 Phase 3

Theriva Biologics ( (TOVX) ) just unveiled an update.

On December 29, 2025, Theriva Biologics reported that it received positive Scientific Advice from the European Medicines Agency’s Committee for Medicinal Products for Human Use on the design of a pivotal Phase 3 trial of its lead oncolytic adenovirus candidate VCN-01 in combination with gemcitabine/nab-paclitaxel as first-line therapy for metastatic pancreatic ductal adenocarcinoma. The agency broadly endorsed Theriva’s plan for a single, double-blind, randomized, placebo-controlled Phase 3 study using overall survival as the primary endpoint, key secondary endpoints such as progression-free survival and duration of response, an adaptive trial design, and a repeated “macrocycle” dosing regimen that allows more than two doses of VCN-01, reflecting survival benefits seen in the prior VIRAGE Phase 2b trial. Theriva, which held $15.5 million in cash as of November 10, 2025 and projects runway into the first quarter of 2027, plans an End-of-Phase 2 meeting with the U.S. FDA in the first half of 2026 to finalize a multinational Phase 3 protocol, with regulatory clarity expected to support partnering, manufacturing scale-up, and potential expansion of VCN-01 development into retinoblastoma, thereby sharpening the company’s late-stage oncology profile.

The most recent analyst rating on (TOVX) stock is a Buy with a $7.00 price target. To see the full list of analyst forecasts on Theriva Biologics stock, see the TOVX Stock Forecast page.

Spark’s Take on TOVX Stock

According to Spark, TipRanks’ AI Analyst, TOVX is a Neutral.

Theriva Biologics faces substantial financial difficulties with no revenue and growing losses, which is a major concern. While technical indicators show some short-term positive momentum, the long-term trend remains negative. The lack of profitability impacts valuation. However, the recent positive clinical trial results provide a potential future catalyst that could improve the company’s prospects.

To see Spark’s full report on TOVX stock, click here.

More about Theriva Biologics

Theriva Biologics (NYSE American: TOVX) is a diversified clinical-stage biopharmaceutical company developing therapeutics for cancer and related diseases with high unmet need. Its pipeline centers on an oncolytic adenovirus platform for intravenous, intravitreal and antitumoral delivery, led by VCN-01 for solid tumors such as metastatic pancreatic ductal adenocarcinoma and retinoblastoma, alongside SYN-004 to protect the gut microbiome in transplant patients and SYN-020 for gastrointestinal and systemic indications.

Average Trading Volume: 16,089,715

Technical Sentiment Signal: Strong Sell

Current Market Cap: $6.45M

Learn more about TOVX stock on TipRanks’ Stock Analysis page.