Pivotal, Week

Pivotal Week Ahead for PDS Biotechnology Shares

03.11.2025 - 13:02:04

Strategic Push for Expedited FDA Approval

PDS Biotechnology Corp (PDSB) is approaching a week of significant developments, with two major catalysts on the horizon. The clinical-stage company is pursuing an accelerated regulatory pathway for its lead cancer immunotherapy candidate, PDS0101, while also anticipating the release of fresh clinical data.

In a strategic move to fast-track its oncology treatment, PDS Biotech has formally requested a meeting with the U.S. Food and Drug Administration. The company aims to discuss a potential accelerated approval pathway for PDS0101, which targets HPV16-positive head and neck cancers. Central to this initiative is a proposed amendment to the protocol of its ongoing VERSATILE-003 Phase 3 clinical trial. PDS Biotech seeks to establish Read more...

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