Medexus provides update on Treosulfan NDA review process and extended PDUFA target date Page 1

Toronto, Ontario and Chicago, Illinois–(Newsfile Corp. – September 16, 2024) – Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) has been informed by medac, the licensor of Medexus’ commercialization rights to treosulfan, that the U.S. Food and Drug Administration has extended the review period for the New Drug Application for treosulfan by three months. The FDA has set a new PDUFA target action date of January 30, 2025.

The FDA has informed medac that the Agency requires additional time to review additional analyses of previously submitted data provided by medac in response to the FDA’s routine requests for information after determining that the additional information constitutes a material change, providing the FDA with up to three additional months to complete their review. The FDA has not requested the submission of new clinical data.