Welcome to our dedicated page for Pds Biotechnology Corporation news (Ticker: PDSB), a resource for investors and traders seeking the latest updates and insights on Pds Biotechnology Corporation stock.
PDS Biotechnology Corporation (Nasdaq: PDSB) is a late-stage immunotherapy company developing investigational cancer therapies based on its Versamune® platform and IL-12 immunocytokine technology. News about PDS Biotech centers on the clinical and regulatory progress of its lead HPV16-targeted immunotherapy PDS0101 and its tumor-targeting IL-12 fused antibody drug conjugate PDS01ADC.
On this page, readers can follow company announcements on pivotal and mid-stage trials, including the VERSATILE-002 Phase 2 study and the VERSATILE-003 Phase 3 trial in HPV16-positive recurrent and/or metastatic head and neck squamous cell cancers. Updates often cover final survival and progression-free survival data, sub-analyses in specific patient subgroups such as low PD-L1 (CPS 1–19) cohorts, and efforts to align with the U.S. Food and Drug Administration on potential accelerated approval pathways.
PDS Biotech news also highlights translational research presented at scientific meetings like the Society for Immunotherapy of Cancer, where investigators have reported immune biomarker signatures, natural killer cell reprogramming, and expansion of stem-like memory T cells associated with PDS0101 and PDS01ADC. Additional coverage includes National Cancer Institute-led Phase 2 trials in metastatic colorectal and other advanced solid tumors, intellectual property developments such as new composition of matter patents for PDS0101, and capital markets events including registered direct offerings disclosed in Form 8-K filings.
Investors and observers who want to track PDSB can use this news feed to monitor clinical milestones, regulatory interactions, scientific data presentations, and financing activities that may influence the company’s development programs and overall outlook.
PDS Biotech (NASDAQ: PDSB) reported full-year 2025 results and clinical updates on March 30, 2026. The company amended its VERSATILE-003 Phase 3 protocol to add PFS as an interim primary endpoint to enable a potential accelerated approval pathway while preserving overall survival for full approval.
Early PDS01ADC Phase 2 data showed median PFS of 9.6 months and a 40% median PSA decline in mCRPC; new U.S. and Japan patents extend Versamune platform protection into the 2040s. Full-year net loss was $34.5M; cash was $26.7M as of Dec 31, 2025.
PDS Biotech (Nasdaq: PDSB) will host a conference call and webcast on March 30, 2026 at 8:00 a.m. ET to report fourth‑quarter and year‑end financial results for the period ended December 31, 2025, and to provide a clinical programs and corporate update.
Access details: domestic dial‑in 1‑877‑704‑4453, international 1‑201‑389‑0920, conference ID 13759288. A webcast will be archived on the company website for six months.
PDS Biotech (Nasdaq: PDSB) adopted an amended protocol for its Phase 3 VERSATILE-003 trial to add progression-free survival (PFS) as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent/metastatic head and neck cancer.
Median overall survival (mOS) remains the primary endpoint for full approval; the company proceeded after the FDA 30-day IND review without objection, and management said the amendment could shorten trial duration and reduce costs.
PDS Biotech (Nasdaq: PDSB) reported NCI-led Phase 2 results for its IL-12 tumor-targeted immunocytokine PDS01ADC combined with docetaxel in 3rd-line metastatic castration-resistant prostate cancer (mCRPC).
Results presented Jan 20–22, 2026 at AACR showed median PFS 9.6 months (range 4.3–32.2) and a median PSA decline of 40%, with 6 of 16 patients achieving >50% PSA decline.
PDS Biotech (Nasdaq: PDSB) announced a U.S. Notice of Allowance for a patent covering PDS0101 (U.S. Application No. 16/210,750) titled “Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes.” The patent will grant composition and method-of-use claims and adds to an existing global IP estate. Combined with anticipated U.S. biologics exclusivity, the company expects approximately 20 years of market protection for PDS0101. PDS0101 is in the Phase 3 VERSATILE-003 trial for HPV16-positive head and neck cancer. The company submitted a protocol amendment to FDA proposing PFS as an earlier primary endpoint to support potential accelerated approval while median overall survival remains the primary endpoint for full approval.
PDS Biotech (NASDAQ: PDSB) submitted a protocol amendment to the FDA on Jan 9, 2026 to change the Phase 3 VERSATILE-003 trial's primary endpoint to progression-free survival (PFS), enabling earlier evaluation with significant statistical power and potentially supporting an accelerated approval pathway for PDS0101 in HPV16-positive recurrent/metastatic head and neck cancer. Median overall survival (mOS) and safety remain required for full FDA approval. The amendment follows a constructive Type C meeting with the FDA in December 2025 and is supported by positive final VERSATILE-002 results reporting promising mOS and durable PFS.
PDS Biotechnology (Nasdaq: PDSB) announced that the Japan Patent Office issued Patent No. 7783866 for PDS0101 on Dec 9, 2025, granting broad composition-of-matter and methods-of-use claims.
The patent expands previously granted Japanese protections and adds to a global IP estate that includes granted patents in the United States, China, Australia, and Hong Kong, with additional applications pending in other countries. The company said this, together with anticipated biologics exclusivity in the United States, provides patent and market protections for PDS0101 into the 2040s. PDS0101 is in a Phase 3 trial studying PDS0101 plus pembrolizumab for HPV16-positive recurrent/metastatic head and neck cancer.
PDS Biotech (Nasdaq: PDSB) announced the FDA accepted its request for a Type C meeting, scheduled for December 2025, to discuss a proposed amendment to the Phase 3 VERSATILE-003 trial.
The amendment would make progression-free survival (PFS) a surrogate primary endpoint evaluable earlier with statistical power, potentially enabling an accelerated approval pathway for PDS0101 in HPV16-positive recurrent/metastatic head and neck cancer. Median overall survival (mOS) will remain the primary endpoint for full approval. The company cites positive final VERSATILE-002 results showing promising mOS and durable PFS in patients with CPS ≥ 1. FDA meeting minutes are expected in January 2026.
PDS Biotech (Nasdaq: PDSB) reported Q3 2025 results and clinical updates on Nov 13, 2025. The company completed the VERSATILE-002 Phase 2 trial of PDS0101 + pembrolizumab in HPV16+ recurrent/metastatic head and neck cancer, reporting a median overall survival (mOS) of 39.3 months (CPS ≥1) and progression-free survival (PFS) of 6.3 months (CPS ≥1).
The company said it will request an FDA meeting to propose an amendment to the ongoing VERSATILE-003 Phase 3 trial to evaluate PFS as a surrogate primary endpoint for potential accelerated approval while retaining mOS for full approval. NCI presented translational data for PDS0101 and PDS01ADC; a colorectal cancer cohort of PDS01ADC met expansion criteria. Financials: net loss $9.0M for Q3; cash of $26.2M as of Sept 30, 2025; recent gross equity/warrant proceeds ~$5.3M.
PDS Biotechnology (Nasdaq: PDSB) announced a registered direct offering to sell 5,800,000 common shares (or pre-funded warrants) at $0.91 per share with accompanying warrants to purchase up to 5,800,000 shares at a $1.00 exercise price.
Initial gross proceeds are expected to be approximately $5.3 million at closing on or about Nov 12, 2025, with up to an additional $5.8 million if all warrants are exercised for cash. The company reported approximately $26.2 million cash as of Sept 30, 2025 (preliminary unaudited).
Proceeds are intended to support the VERSATILE-003 Phase 3 trial, planned FDA protocol discussions, R&D, and general corporate purposes. The company also agreed to amend existing warrants to reduce the exercise price from $1.50 to $1.00, exercisable six months after closing.