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Enables Potential Shorter Time to Accelerated Approval of PDS0101 in HPV16-positive Head and Neck Cancer Enables Potential Shorter Time to Accelerated Approval of PDS0101 in HPV16-positive Head and Neck Cancer
NCI-Led Study Shows Median PFS of 9.6 Months Results Presented at AACR Special Conference on Innovations in Prostate Cancer
Patent Enhances IP Estate for Lead Asset; Combined with Anticipated Biologics Exclusivity, Market Protections Extend Over 20 Years Patent Enhances IP Estate for Lead Asset; Combined with Anticipated Biologics Exclusivity, Market Protections Extend Over 20 Years
PDS Biotech Submits Amended Protocol for Phase 3 VERSATILE-003 Trial Constructive Type C Meeting Provides Potential Pathway to Accelerated Approval of PDS0101 PRINCETON, N.J., Jan. 09, 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 that the Company has submitted a protocol amendment to the U.S. Food & Drug Administration (“FDA”) for its Phase 3 VERSATILE-003 clinical trial.
PDS Biotechnology Corporation (NASDAQ: PDSB - Get Free Report) traded down 1.9% during trading on Tuesday. The stock traded as low as $0.8746 and last traded at $0.9010. 355,481 shares changed hands during trading, a decline of 40% from the average session volume of 595,547 shares. The stock had previously closed at $0.9186. Analyst Upgrades
New Patent Grants Broad Composition Claims for PDS0101 Previously Granted Patent Protections and Anticipated Market Exclusivity Provide Protection for PDS0101 in the United States into the 2040s PRINCETON, N.J., Dec. 09, 2025 (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 that the Japan Patent Office has issued Patent No.
PDS Biotechnology (PDSB) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
Company to Discuss Proposed Amendment to Phase 3 VERSATILE-003 Trial Enabling Potential Accelerated Approval Pathway Company to Discuss Proposed Amendment to Phase 3 VERSATILE-003 Trial Enabling Potential Accelerated Approval Pathway
PDS Biotechnology Corporation ( PDSB ) Q3 2025 Earnings Call November 13, 2025 8:00 AM EST Company Participants Frank Bedu-Addo - President, CEO & Director Lars Boesgaard - Principal Financial & Accounting Officer and CFO Kirk Shepard - Chief Medical Officer Conference Call Participants Thomas Johnson - Lifesci Advisors, LLC Mayank Mamtani - B. Riley Securities, Inc., Research Division Joseph Pantginis - H.C.
Company Announced Completion of VERSATILE-002 Phase 2 trial of PDS0101 + Pembrolizumab in HPV16-Positive Recurrent/Metastatic Head and Neck Cancer
PRINCETON, N.J., Nov. 11, 2025 (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 that it has entered into a securities purchase agreement for the purchase and sale of 5,800,000 shares of common stock (or pre-funded warrants in lieu thereof) at a purchase price of $0.91 per share and accompanying warrants to purchase up to an aggregate of 5,800,000 shares of its common stock in a registered direct offering (the “Offering”).
Translational study shows that multiple immunological biomarkers predict the clinical activity of PDS0101 combination therapy PDS01ADC reprograms natural killer (NK) cells to possess characteristics that make them more active in killing cancer cells PDS01ADC promotes stem cell-like killer T cells and memory T cells that self-replicate and are therefore capable of potent and long-lasting anti-tumor activity PRINCETON, N.J., Nov. 10, 2025 (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 positive clinical and translational data presented at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting.
PRINCETON, N.J., Nov. 06, 2025 (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 that the Company will host a conference call to report financial results for the quarter ended September 30, 2025 and provide a clinical programs update on Thursday, November 13, 2025 at 8:00 am Eastern Time.
Three abstracts accepted for presentation, including one rapid oral abstract session Presentations to highlight ongoing clinical and translational research across PDS Biotechnology's immunotherapy platforms PRINCETON, N.J., Oct. 30, 2025 (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 that the National Cancer Institute (NCI) will present new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place in National Harbor, Maryland.
Company aims to shorten time frame to make PDS0101 available to patients with HPV16-positive head and neck cancer, projected to be the most dominant type of head and neck cancer in the US by mid 2030s Proposed Amendment to Ongoing VERSATILE-003 Trial to include PFS Endpoint Based Upon Final VERSATILE-002 Trial Data Showing Robust Median Progression Free Survival of 6.3 months and Increased Median Overall Survival of 39.3 months PRINCETON, N.J., Oct. 29, 2025 (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 that after recent review of the final VERSATILE-002 data, the Company has requested a meeting with the Food and Drug Administration (“FDA”) to explore an expedited approval pathway for PDS0101 in HPV16-positive Head and Neck Cancer.
First combination therapy to report 29.5 months of Median Overall Survival (mOS); Standard of care Keytruda ® (pembrolizumab) alone (10.8 months) and Keytruda ® + chemotherapy (12.3 months) in patients with CPS 1-19*
PRINCETON, N.J., Sept. 02, 2025 (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 that the Company will participate in the 27th Annual H.C.
Median Overall Survival (mOS) of 39.3 months in patients with CPS ≥ 1 – best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months*
PDS Biotechnology Corporation (NASDAQ:PDSB ) Q2 2025 Earnings Conference Call August 13, 2025 8:00 AM ET Company Participants Frank K. Bedu-Addo - President, CEO & Director Kirk V.
Multiple Abstracts Presented at the 2025 American Society of Clinical Oncology Annual Meeting Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J.