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OncoZenge Provides Regulatory Update on BupiZenge™ Phase III Trial

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.

BupiZenge™ - Potential to be the leading treatment for oral pain.

Contact
Stian Kildal CEO Mobile: +46 76 115 3797 E-mail: stian.kildal@oncozenge.se

About
OncoZenge AB (publ) is a clinical-stage pharmaceutical company developing an innovative, effective, and well-tolerated treatment for oral pain in conditions where current options are insufficient, such as oral mucositis from cancer therapy. Its lead candidate, BupiZenge™, represents a novel formulation of bupivacaine in a lozenge form, aimed at providing rapid and sustained local pain relief without the risks associated with systemic opioids. OncoZenge is headquartered in Stockholm, Sweden, and is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ. For more information, please visit www.oncozenge.se.

OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden

Certified Adviser
Redeye Nordic Growth AB is the company’s Certified Adviser.

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OncoZenge Provides Regulatory Update on BupiZenge™ Phase III Trial

Datum 2026-05-19, kl 13:40
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OncoZenge Provides Regulatory Update on BupiZenge™ Phase III Trial