OncoZenge AB (publ) (“OncoZenge” or “the Company”) today announces that it has received written notification from European authorities regarding the ongoing assessment of its Clinical Trial Application (CTA) for the BupiZenge™ Phase III trial, ‘BEAM-Pain’. The authorities have confirmed that a final conclusion will be provided no later than May 29, 2026.
On April 28, 2026, the Company received conditional acceptance for the initiation of the trial. The single outstanding condition was promptly addressed in collaboration with its suppliers, and the necessary updates to the CTA were submitted. The Company was subsequently expecting a formal decision around mid-May. European authorities have today confirmed that a final conclusion will be provided no later than May 29, 2026.
OncoZenge has received no further questions from the authorities and remains confident of a positive outcome. Preparations for the Phase III study continue according to plan, with the objective of enrolling the first patient during Q2 2026.