secwatch.observer — SEC 8-K summary
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Issuer:     Theriva Biologics, Inc. (TOVX)
CIK:        0000894158
Form:       8-K
Filed at:   2026-07-07T12:10:51+00:00
Accession:  0001104659-26-080962
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Theriva Biologics gets Spanish regulator approval to start VIRAGE2 Phase 2a trial of VCN-01 in pancreatic cancer
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- AEMPS authorized VIRAGE2, a Phase 2a trial evaluating at least 3 doses of VCN-01 given 2 months apart with gemcitabine/nab-paclitaxel in first-line metastatic PDAC.
- VIRAGE2 builds on VIRAGE Phase 2b (112 patients) where 2 doses of VCN-01 3 months apart significantly improved overall survival, PFS, and duration of response vs. 1 dose or SoC alone.
- EMA and FDA recognized improved survival with 2 doses and suggested more frequent dosing could improve outcomes.
- Results will inform dosing regimen for a potential future pivotal Phase 3 trial.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/894158/000110465926080962/0001104659-26-080962-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/894158/000110465926080962/tm2619846d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-080962

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer