secwatch.observer — SEC 8-K summary
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Issuer:     PDS Biotechnology Corp (PDSB)
CIK:        0001472091
Form:       8-K
Filed at:   2026-02-20T23:59:59+00:00
Accession:  0001140361-26-006229
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PDS Biotech amends Phase 3 VERSATILE-003 trial to add PFS endpoint for potential accelerated approval of PDS0101
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- Adopted protocol amendment for Phase 3 VERSATILE-003 trial adding progression-free survival as interim primary endpoint.
- PFS endpoint supports potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent/metastatic head and neck cancer.
- Median overall survival remains primary endpoint for full approval, per prior FDA Type C meeting.
- FDA 30-day review period ended without objection; company proceeding with amended protocol.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472091/000114036126006229/0001140361-26-006229-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472091/000114036126006229/ef20066174_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-006229

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