PDS Biotechnology Corp 8-K

What Happened
PDS Biotechnology Corporation (PDSB) filed an 8-K on February 20, 2026 and issued a press release announcing a protocol amendment to its Phase 3 VERSATILE‑003 trial. The amendment adds progression‑free survival (PFS) as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16‑positive recurrent and/or metastatic head and neck cancer. Median overall survival (mOS) remains the trial’s primary endpoint for full approval, consistent with prior regulatory discussions and post‑meeting communication following a Type C meeting with the U.S. Food and Drug Administration (FDA).

Key Details

• Filing date: February 20, 2026; press release filed as Exhibit 99.1 to the 8‑K.
• Trial: Phase 3 VERSATILE‑003, indication HPV16‑positive recurrent/metastatic head and neck cancer.
• Amendment: Adds progression‑free survival (PFS) as an interim primary endpoint to support accelerated approval; median overall survival (mOS) remains the primary endpoint for full approval.
• Regulatory: Following submission of the amended protocol to the IND, the FDA’s standard 30‑day wait period passed without objection and the Company is proceeding with the amendment.

Why It Matters
Adding PFS as an interim primary endpoint creates a clearer pathway to a potential accelerated approval, which could allow earlier regulatory clearance if the trial shows strong PFS benefit. Keeping mOS as the primary endpoint for full approval means the Company still must demonstrate overall survival benefit for traditional approval. For investors, this is an operational and regulatory update that could affect trial timelines and potential near‑term value inflection points for PDS0101; the filing does not report clinical results or financial changes.