secwatch.observer — SEC 8-K summary
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Issuer:     Theriva Biologics, Inc. (TOVX)
CIK:        0000894158
Form:       8-K
Filed at:   2026-03-23T23:59:59+00:00
Accession:  0001104659-26-033051
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Theriva Biologics obtains FDA agreement on Phase 3 trial design for VCN-01 in metastatic PDAC
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- FDA provided general agreement on proposed Phase 3 trial design for VCN-01 plus gemcitabine/nab-paclitaxel.
- Phase 3 trial will track successful VIRAGE Phase 2 design with repeat dosing and adaptive elements.
- FDA agreed on primary endpoint (OS), key secondary endpoints, inclusion/exclusion criteria, and dosing schedule.
- Consistent with prior EMA advice; company to finalize protocol and pursue funding or partnerships.
- VIRAGE Phase 2 met primary endpoints; improved OS, PFS, DoR for VCN-01 plus SoC vs SoC alone in metastatic PDAC.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/894158/000110465926033051/0001104659-26-033051-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/894158/000110465926033051/tm269559d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-033051

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