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Clinical trials
catalyst calendar across sponsors →Studies where PDSB is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
3 interventional
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaNCT06790966Overall Survival (OS)Randomized · Open-label · Treatment | Phase 3 | Active, not recruiting | Combination product: Combination Treatment of PDS0101 and Pembrolizumab · Drug: Pembrolizumab Monotherapy | Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Neoplasms, Head and Neck, Unresectable Head and Neck Squamous Cell Carcinoma | 252 | Feb 2029 | ≤ 924 d | 2026-04-06 |
| Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCCNCT04260126Best Overall Response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) of the combination of pembrolizumab and PDS0101.Open-label · Treatment | Phase 2 | Completed | Combination product: Pembrolizumab (KEYTRUDA®) and PDS0101 | Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Neoplasms, Head and Neck | 95 | 2025-05-14actual | — | 2025-10-01 |
| An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101NCT02065973Evaluation or determination of adverse events following vaccinationNon-randomized · Open-label · Treatment | Phase 1 | Completed | Biological: R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7 | High-risk HPV Infection and Biopsy-proven CIN1 | 12 | 2015-12-30actual | — | 2018-12-13 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19