Stockholm, May 19, 2026 – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company specializing in difficult-to-treat cancers, today announces that its clinical trial application for the "Window-of-Opportunity" (WoO) study in glioblastoma has been formally approved in Norway. The approval was issued jointly by Direktoratet for medisinske produkter (the Norwegian Medical Products Agency, DMP and the ethics committee (REK KULMU).
The authorization, received sooner than the company had expected, means the planned study is formally approved to commence. The decision follows the previously announced regulatory agreement on the trial design and the fast-track designation granted in Norway.
The WoO study represents the first 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 enroll approximately 10 patients and aims to quickly verify that the company's technology successfully penetrates the human blood-brain barrier, paving the way for the subsequent clinical development of its 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 for initiating patient recruitment in Norway,” said Sofia Heigis, CEO of Oncopeptides. “This swift turnaround confirms the strong alignment and efficient collaboration we have experienced with the Scandinavian authorities, and we look forward to generating human clinical data in this highly underserved indication.”
For more information, including a Q&A for investors, please visit www.oncopeptides.com