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PDS Biotechnology Corporation reports developments in targeted cancer immunotherapies based on its Versamune platform. Company news centers on PDS0101, also called Versamune HPV, in HPV16-positive head and neck cancer, and on PDS01ADC, an IL-12 fused antibody drug conjugate and tumor-targeted immunocytokine evaluated across multiple solid tumor indications.
Recurring updates include clinical-trial data, National Cancer Institute-led study presentations, FDA and IND protocol communications, scientific publications, patent coverage for core technology, quarterly financial results, and broader corporate-program updates.
PDS Biotech (Nasdaq:PDSB) reported Q1 2026 results and clinical updates. The VERSATILE-003 Phase 3 protocol now uses progression-free survival as an interim primary endpoint, potentially supporting accelerated approval of PDS0101, while overall survival remains the primary endpoint for full approval.
Stage 1 data for PDS01ADC in metastatic colorectal cancer showed 77.8% ORR (7/9) and ~85% 24‑month survival. Early metastatic castration-resistant prostate cancer data reported median PFS of 9.6 months. New U.S. and Japan patents extend PDS0101 protection into the 2040s. Q1 2026 net loss was $7.3M ($0.13/share) versus $8.5M ($0.21/share) a year earlier; operating expenses were $6.5M, and cash was $21.7M.
PDS Biotech (Nasdaq: PDSB) will host a conference call and webcast on May 13, 2026 at 8:00 a.m. ET to report first quarter results for the period ended March 31, 2026, and provide a clinical programs and corporate update.
Dial-in details and a webcast will be available 15 minutes prior; the webcast archive will remain on the company website for six months.
PDS Biotech (Nasdaq: PDSB) announced publication of interim Stage 1 Phase 2 data for PDS01ADC in JCO Oncology Advances on April 15, 2026. Stage 1 (N=9) reported a 77.8% ORR, ~85% 24-month survival and median extrahepatic PFS not reached (min follow-up 13.1 months).
Comparators from a parallel trial without PDS01ADC showed a 35% ORR, ~40% 2-year survival and 8.1-month PFS; no head-to-head randomized comparison was performed.
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.