Pds biotech to seek expedited approval pathway for pds0101 in hpv16-positive head and neck cancer

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.
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