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Theriva Biologics, Inc. develops therapeutics for cancer and related diseases as a diversified clinical-stage biotechnology company. Its subsidiary, Theriva Biologics, S.L., is developing an oncolytic adenovirus platform for intravenous, intravitreal and antitumoral delivery. The company’s lead candidate, VCN-01, is designed to replicate selectively within tumor cells and degrade the tumor stroma barrier associated with cancer treatment resistance.
Recurring Theriva Biologics news includes VCN-01 clinical data in metastatic pancreatic ductal adenocarcinoma and retinoblastoma, regulatory interactions with U.S. and European agencies, medical-conference presentations, and operational financial results. Coverage also includes SYN-004, or ribaxamase, for gastrointestinal degradation of certain IV beta-lactam antibiotics, and the licensed SYN-020 recombinant intestinal alkaline phosphatase program.
Theriva Biologics (NYSE American:TOVX) reported Phase 1 results of IV VCN-01 plus durvalumab in metastatic, immunotherapy-refractory head and neck squamous cell carcinoma.
The 20-patient trial showed prolonged overall survival (up to 17.3 months) and pharmacokinetic and biomarker changes consistent with VCN-01’s stroma-degrading and immune-enhancing mechanisms.
Theriva Biologics (NYSE: TOVX) reported Q1 2026 operational highlights and results, focusing on regulatory progress for lead candidate VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC) and retinoblastoma. The company aligned with the FDA on a Phase 3 PDAC design and presented VIRAGE Phase 2b data suggesting a possible immune-mediated mechanism.
Theriva made VCN-01 available for compassionate use in retinoblastoma, treated two patients, and expects a Spain dosing-feasibility study in H2 2026. Cash was $14.4 million at March 31, 2026, with runway into Q1 2027.
Theriva Biologics (NYSE American: TOVX) will present additional tumor response, biomarker, and subgroup analyses from the VIRAGE Phase 2b trial of VCN-01 plus gemcitabine/nab-paclitaxel at AACR 2026 in San Diego on April 20, 2026.
The poster (CT162) by Dr. Manuel Hidalgo reports data supporting an immune-mediated mode of action and improved outcomes across multiple subgroups, including patients with liver metastases. The company says it has alignment with the FDA and EMA on a proposed pivotal Phase 3 and plans a small dosing study to test more frequent/extended VCN-01 dosing.
Theriva Biologics (NYSE: TOVX) secured positive End-of-Phase 2 feedback from the U.S. FDA on March 23, 2026, enabling advancement to a proposed pivotal Phase 3 trial of VCN-01 plus gemcitabine/nab-paclitaxel for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).
FDA agreed with the proposed randomized, double-blind design, repeat "macrocycle" dosing, primary endpoint of overall survival, key secondaries including PFS, and adaptive interim-analysis/statistical plans; combined FDA and EMA advice lets the company finalize protocol and pursue development funding or partnerships.
Theriva Biologics (NYSE: TOVX) reported full-year 2025 results and a corporate update on March 12, 2026. Key items: VCN-01 advancing toward pivotal PDAC Phase 3 after positive EMA scientific advice; SYN-020 licensed to Rasayana with up to $38 million in milestones plus royalties; cash of $13.1M at year-end and ~$15.2M as of Feb 26, 2026, funding operations into Q1 2027.
Theriva Biologics (NYSE American: TOVX) licensed SYN-020 to Rasayana Therapeutics in an exclusive, worldwide deal announced Feb 18, 2026. Theriva received a $300,000 upfront payment and may earn up to $38M in development, regulatory and sales milestones plus tiered single-digit royalties.
Rasayana will assume all development and commercialization costs; SYN-020 completed Phase 1 safety testing and is expected to enter Phase 2 under Rasayana's stewardship.
Theriva Biologics (NYSE: TOVX) will present Phase 1 clinical outcomes and safety data for VCN-01 in refractory retinoblastoma at APAO 2026 in Hong Kong on 07 February 2026.
The invited session includes intravitreal two-injection trial results (NCT03284268), preclinical data showing synergy with topotecan, presentation logistics, and note of Orphan Drug and Rare Pediatric Disease designations and ongoing pivotal trial planning.
Theriva Biologics (NYSE:TOVX) received Scientific Advice from the EMA CHMP on a proposed double-blind, randomized, placebo-controlled Phase 3 trial of VCN-01 plus gemcitabine/nab-paclitaxel for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).
CHMP agreed on overall survival as primary endpoint, key secondary endpoints, inclusion/exclusion criteria, sample size, and an adaptive design. CHMP supported repeated “macrocycle” dosing (more than two doses) after positive VIRAGE Phase 2b signals. Theriva plans an FDA End-of-Phase 2 meeting in H1 2026. Cash of $15.5M provides runway into Q1 2027 to complete regulatory and partnering activities.
Theriva Biologics (NYSE: TOVX) reported Q3 2025 operational and financial results with key clinical updates and cash guidance. Expanded VIRAGE Phase 2b data for VCN-01 in metastatic PDAC showed the study met primary endpoints with improved OS, PFS and DoR, measurable viral genomes for ≥3 months, and greater benefit with two doses.
Preclinical data for next‑gen VCN-12 showed higher tumor killing and hyaluronidase activity versus VCN-01. Cash was $7.5M at Sept 30, 2025 and increased to $15.5M by Nov 10, 2025, funding operations into Q1 2027.
Theriva Biologics (NYSE American: TOVX) announced awareness of unusual trading activity in its common stock on the NYSE American on October 24, 2025. The company said it has made inquiries, does not believe corrective actions are appropriate, and is not aware of any material development in its business or affairs that would explain the trading.
The company noted a prior announcement on October 13, 2025 about presenting expanded data from the VIRAGE trial of VCN-01 at a mini oral session during ESMO 2025.