PDS Biotech Announces Adoption of Amended Protocol for Phase 3 VERSATILE-003 Trial Incorporating Progression Free Survival (PFS) as Primary Endpoint for Interim Analysis and Potential Acce...
PDS Biotechnology Corporation (PDSB)
Last pds biotechnology corporation earnings: 11/7 06:00 am
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Source: GlobeNewswire
PRINCETON, N.J., Feb. 20, 2026 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes 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 the Company’s prior regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration (“FDA”). Following the FDA's standard 30-day wait period since filing of the amended protocol to the Investigational New Drug (IND) Application, without objection, the Company is proceeding with the amended protocol. “Includi
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News
- PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCIGlobeNewswire
- PDS Biotech Announces New U.S. Patent Covering Technology Underlying PDS0101 [Yahoo! Finance]Yahoo! Finance
- PDS Biotech Announces New U.S. Patent Covering Technology Underlying PDS0101GlobeNewswire
- PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary EndpointGlobeNewswire
- PDS Biotech Announces New Composition of Matter Patent for PDS0101 in JapanGlobeNewswire
PDSB
Earnings
- 11/13/25 - Beat
PDSB
Sec Filings
- 2/20/26 - Form 8-K
- 1/28/26 - Form 8-K
- 1/22/26 - Form 8-K
- PDSB's page on the SEC website