secwatch.observer — SEC 8-K summary
======================================

Issuer:     Theriva Biologics, Inc. (TOVX)
CIK:        0000894158
Form:       8-K
Filed at:   2024-05-23T23:59:59+00:00
Accession:  0001104659-24-064544
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Theriva Biologics receives FDA Fast Track Designation for VCN-01 in metastatic pancreatic cancer
--------------------------------------------------------------------------------

- FDA granted Fast Track Designation for VCN-01 combined with gemcitabine/nab-paclitaxel for metastatic pancreatic adenocarcinoma.
- VCN-01 is being evaluated in the ongoing Phase 2b VIRAGE trial as first-line therapy for pancreatic ductal adenocarcinoma.
- Enrollment in VIRAGE expected to complete in Q3 2024.
- Previously, FDA granted orphan drug designation to VCN-01 for PDAC.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/894158/000110465924064544/0001104659-24-064544-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/894158/000110465924064544/tm2415354d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-064544

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