Press release

Update on the Type II application process

December 15, 2023

Stockholm – December 15, 2023 – Oncopeptides today announces that the European Commission has decided to formally approve the company’s application to the European Medicines Agency (EMA) for an extended indication for Pepaxti into earlier lines. The previously communicated decision by Oncopeptides to opt out of the process to extend the indication remains.

Oncopeptides has submitted an application to adjust the indication of Pepaxti to the originally approved indication, a process that is expected to be finalized in early 2024. During this time, Oncopeptides will work together with the European Commission, EMA as well as local stakeholders to ensure an efficient removal process for the extended indication.

For more information, including a Q&A for investors, please visit Oncopeptides’ website.