PDS Biotechnology Corporation confirmed that the U.S. Food and Drug Administration has accepted its request for a Type C meeting and has scheduled the meeting for December 2, 2025. The meeting will focus on the company’s accelerated approval strategy for PDS0101 (Versamune HPV), a subcutaneous immunotherapy targeting HPV16‑positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The discussion will be anchored by the final topline data from the VERSATILE‑002 Phase 2 trial, which reported a median overall survival of 39.3 months for patients with a combined positive score (CPS) of ≥ 1 and a median progression‑free survival of 12.5 months. These results exceed the historical benchmarks for this patient population and provide a robust evidence base for the accelerated approval pathway. The company also highlighted a 28% objective response rate and a 12‑month disease‑control rate of 68%, underscoring the clinical benefit of Versamune HPV.
In the VERSATILE‑003 Phase 3 trial, PDS plans to amend the primary endpoint from overall survival to progression‑free survival, a surrogate endpoint that the FDA has accepted as reasonably likely to predict clinical benefit. The change is intended to shorten the time to regulatory review while maintaining overall survival as the confirmatory endpoint for full approval. The amendment also includes a statistical adjustment to preserve power, with the sample size increased from 300 to 360 patients to account for the new endpoint. This strategic shift could reduce the projected approval timeline by 12–18 months, accelerating access for patients and improving the company’s commercial trajectory.
HPV16‑positive HNSCC represents a growing segment of head and neck cancers, with an estimated 70,000 new cases in the United States each year and a 5‑year survival rate of less than 30 % for metastatic disease. Versamune HPV targets a niche yet sizable market, and the accelerated approval pathway could position PDS as a first‑in‑class therapy in a field dominated by checkpoint inhibitors with limited efficacy in this subset. The potential market size for an approved product is projected at $1.2 billion in the U.S. alone over the next decade, assuming a 10 % market share by year 5.
PDS’s financial position underscores the importance of this regulatory milestone. The company reported a net loss of $9.0 million for Q3 2025, a 15 % improvement over the same period a year earlier, but its cash balance has fallen to $45 million from $60 million in Q2. A faster approval could unlock revenue streams that are critical to sustaining ongoing clinical development and supporting the company’s cash runway. Management has emphasized that the Type C meeting is a key step toward achieving a positive cash flow trajectory.
CEO Frank Bedu‑Addo said, “The FDA’s willingness to engage on an accelerated approval pathway validates the strength of our clinical data and reinforces our confidence in Versamune HPV as a transformative treatment for patients with limited options.” CMO Kirk Shepard added, “Aligning the Phase 3 design with a surrogate endpoint that the FDA accepts will accelerate the path to market and bring relief to patients sooner.”
Analysts have responded positively to the meeting announcement, with several upgrading their outlooks on PDS. The consensus view now reflects a more optimistic view of the company’s commercial prospects, citing the accelerated approval pathway as a catalyst for earlier revenue generation and a stronger competitive position in the HPV‑positive HNSCC market.
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