Why Is Theriva Biologics Stock Gaining Monday?

Theriva Biologics, Inc. (NYSE:TOVX) stock rose on Monday, with a session volume of 114.18 million compared to the average volume of 15.61 million, as per data from Benzinga Pro.

The company received Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on the design of a Phase 3 trial of lead clinical candidate VCN-01.

The trial will evaluate VCN-01 in combination with gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC).

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Phase 2 Data Show Survival Benefits

The company has previously reported the results of the VIRAGE phase 2 trial, demonstrating that PDAC patients in the VCN-01 plus gemcitabine/nab-paclitaxel SoC treatment arm demonstrated increased overall survival, progression-free survival, and duration of response compared to patients in the control arm treated with gemcitabine/nab-paclitaxel SoC alone.

Even greater increases in these parameters were observed in patients who received two doses of VCN-01 administered 3 months apart.

Regulatory Path Toward Approval

CHMP advised that a potential future marketing authorization application (MAA) for VCN-01 in metastatic PDAC could be supported by Theriva’s proposed clinical development strategy if the phase 3 trial demonstrates a compelling benefit-risk ratio with VCN-01 plus gemcitabine/nab-paclitaxel SoC compared to gemcitabine/nab-paclitaxel SoC alone.

The CHMP recognized the increased improvement in overall survival of patients receiving two doses of VCN-01 in the VIRAGE study, and agreed with the proposed dosing of VCN-01 and gemcitabine/nab-paclitaxel in repeated “macrocycles”, enabling more than two doses of VCN-01 to be administered in the Phase 3 trial.

They further suggested that more frequent dosing of VCN-01 could be considered.

Cash Position and Runway

On November 10, 2025, Theriva had $15.5 million in cash and equivalents, providing runway into the first quarter of 2027 as the company completes interactions with regulatory agencies regarding the PDAC and retinoblastoma programs and pursues partnerships to support VCN-01 manufacturing scale-up and conduct of the proposed pivotal clinical trial(s).

TOVX Price Action: Theriva Biologics shares were up 4.03% at $0.19 at the time of publication on Monday, according to Benzinga Pro data.

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