Stockholm, May 19, 2026 – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company specialized in hard-to-treat cancers, today announces that the company’s clinical trial application for the “Window-of-Opportunity” (WoO) study in glioblastoma has been formally approved in Norway. The approval was issued jointly by the Norwegian Medical Products Agency (DMP) and the ethics committee (REK KULMU).
The approval, which was received earlier than the company had expected, means that the planned study is now approved to commence. The decision follows the previously communicated regulatory alignment regarding the study design and the granted “fast-track” status in Norway.
The WoO study represents the first-ever clinical evaluation of a peptide-drug conjugate (PDC) in glioblastoma, marking an important operational step in Oncopeptides’ strategy to expand its proprietary PDC platform beyond multiple myeloma. The trial will include approximately 10 patients and aims to rapidly verify that the company’s technology successfully penetrates the human blood-brain barrier, paving the way for the subsequent clinical development of the next-generation asset, OPD5.
“The formal approval from DMP and REK is a critical milestone that allows us to move directly into the practical preparations to initiate patient recruitment in Norway,” says Sofia Heigis, CEO of Oncopeptides. “This rapid decision confirms the strong alignment and effective cooperation we have experienced with the Scandinavian authorities, and we look forward to generating human clinical data in this indication with very high unmet medical needs.”
For more information, including Q for investors, please visit www.oncopeptides.com