PDS Biotechnology Corp 8-K

What Happened
PDS Biotechnology Corporation (PDSB) announced on January 9, 2026 that it has submitted a protocol amendment to the U.S. Food and Drug Administration (FDA) for its Phase 3 VERSATILE‑003 clinical trial. The proposed change would make progression‑free survival (PFS) a primary endpoint that can be evaluated earlier with significant statistical power, potentially supporting an accelerated approval pathway for its cancer vaccine candidate PDS0101. Median overall survival remains the primary endpoint for full approval, as originally recommended by the FDA.

Key Details

• Amendment submitted to FDA on January 9, 2026 for the VERSATILE‑003 Phase 3 trial.
• Proposal: change progression‑free survival (PFS) to a primary endpoint that can be evaluated earlier.
• Purpose: potentially provide the basis for accelerated approval of PDS0101.
• Median overall survival remains the designated primary endpoint for full approval per FDA guidance.
• Company filed a press release announcing the submission (Exhibit 99.1 to the 8‑K).

Why It Matters
If the FDA accepts the amendment, PDS0101 could be evaluated for accelerated approval sooner than waiting for median overall survival results, which may create an earlier regulatory milestone and value inflection for investors. However, the filing is a submission only — FDA review and acceptance are required, and full approval would still rely on overall survival data. This is a regulatory-development update rather than a financial disclosure; investors should watch for FDA feedback and any subsequent trial or company announcements.