PDS Biotechnology Corporation
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- PDS Biotechnology Corporation (NasdaqGS: PDSB), a clinical-stage immunotherapy company, develops targeted cancer immunotherapies based on its proprietary Versamune platform technology, which activates and directs T-cell responses against tumors; the company also advances PDS01ADC, a tumor-targeted antibody-drug conjugate that delivers interleukin-12 to suppress tumor defenses while enhancing T-cell infiltration and potency. Its lead candidate, PDS0101 (Versamune HPV), targets HPV16-positive cancers including head and neck squamous cell carcinoma, cervical, anal, and oropharyngeal cancers, either as monotherapy or in combinations with checkpoint inhibitors like pembrolizumab or chemoradiotherapy; additional pipeline programs include PDS0301, an IL-12 conjugate for advanced solid tumors, Versamune MUC1 for prostate, breast, and other MUC1-expressing cancers, and preclinical efforts in colorectal cancer, metastatic breast cancer, and universal influenza vaccines. PDS Biotechnology Corporation operates primarily in the United States with a focus on oncology and infectious diseases, serving patients with advanced and recurrent cancers through clinical trials targeting unmet needs in immunotherapy. Founded in 2005 and headquartered in Princeton, New Jersey, the company maintains a research-driven model with no noted subsidiaries or parent relationships. Recent developments include the initiation of the VERSATILE-003 Phase 3 pivotal trial for PDS0101 in combination with pembrolizumab for recurrent/metastatic HPV16-positive head and neck squamous cell cancer in March 2025 following FDA clearance and Fast Track designation; completion of enrollment and topline survival data from the VERSATILE-002 Phase 2 trial showing median overall survival of 39.3 months in November 2025; FDA clearance of an IND for Versamune MUC1 combined with PDS01ADC in metastatic breast cancer in March 2025; expansion of the PDS01ADC Phase 2 colorectal cancer cohort in July 2025; up to $11.1 million registered direct offering in November 2025 and a prior $22 million offering in February 2025 to fund clinical advancement; and a scheduled Type C meeting with the FDA in December 2025 to discuss expedited approval pathways for PDS0101.
PDS Biotechnology Q1 Earnings Call Highlights
PDS Biotechnology Corporation (PDSB) Q1 2026 Earnings Call Transcript
PDS Biotech Reports First Quarter 2026 Financial Results and Provides Clinical Programs and Corporate Update
PDS Biotech Announces Conference Call and Webcast for 2026 First Quarter Financial Results
PDS Biotech Announces Publication of Positive PDS01ADC Interim Phase 2 Clinical Trial Data from Stage 1 of NCI-led Metastatic Colorectal Cancer (mCRC) Trial
PDS Biotechnology Corporation (PDSB) Q4 2025 Earnings Call Transcript
PDS Biotech Reports Full Year 2025 Financial Results and Provides Update on PDS0101 Phase 3 Program and PDS01ADC Clinical Advancement
PDS Biotech Announces Conference Call and Webcast for 2025 Fourth Quarter and Year End Financial Results
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 Accelerated Approval
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 NCI
PDS Biotech Announces New U.S. Patent Covering Technology Underlying PDS0101
PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint
PDS Biotechnology (NASDAQ:PDSB) Shares Down 1.9% – Here’s What Happened
PDS Biotech Announces New Composition of Matter Patent for PDS0101 in Japan
PDS Biotechnology (PDSB) Upgraded to Buy: Here's Why
PDS Biotech Announces Scheduling of Type C Meeting with U.S. Food and Drug Administration (“FDA”)
PDS Biotechnology Corporation (PDSB) Q3 2025 Earnings Call Transcript
PDS Biotech Reports Third Quarter 2025 Financial Results and Provides Clinical Programs Update
PDS Biotechnology Announces up to $11.1 Million Registered Direct Offering
PDS Biotechnology Announces Translational Data Showing Strong Immunological and Clinical Activity of PDS0101 and PDS01ADC Presented at SITC 2025