secwatch.observer — SEC 8-K summary
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Issuer:     PDS Biotechnology Corp (PDSB)
CIK:        0001472091
Form:       8-K
Filed at:   2026-01-09T23:59:59+00:00
Accession:  0001140361-26-000786
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud

PDS Biotech Submits FDA Protocol Amendment for Phase 3 VERSATILE-003, PFS Endpoint for Accelerated Approval
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- On January 9, 2026, PDS Biotech submitted a protocol amendment to the FDA for its Phase 3 VERSATILE-003 trial.
- The amendment changes progression free survival (PFS) to a primary endpoint for earlier evaluation, potentially enabling accelerated approval of PDS0101.
- Median overall survival remains the primary endpoint for full approval as originally recommended by FDA.
- The amendment follows a constructive Type C meeting with the FDA in December 2025.
- The amendment is supported by positive final results from VERSATILE-002 trial showing promising mOS and durable PFS.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472091/000114036126000786/0001140361-26-000786-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472091/000114036126000786/ef20062601_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-000786

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