Mr. Ken d'Entremont reports

MEDEXUS PROVIDES UPDATE ON TREOSULFAN NDA REVIEW PROCESS AND EXTENDED PDUFA GOAL DATE

Medexus Pharmaceuticals Inc. has been informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application for treosulfan by three months. The FDA has set a new PDUFA (the Prescription Drug User Fee Act) target action date of Jan. 30, 2025.

The FDA notified medac that the agency requires additional time to review supplemental analyses of previously submitted data that had been provided by medac in response to the FDA's routine information requests, having determined that the additional information constitutes a major amendment, which allows the FDA up to three additional months to complete their review. The FDA has not requested submission of new clinical data.

"We recognize that this development further extends the regulatory review process timeline," commented Ken d'Entremont, Medexus's chief executive officer. "Nevertheless, we are encouraged to see that the FDA remains actively engaged with medac, and we continue to prepare for an approval of treosulfan in the United States and a commercial launch in the first half of calendar year 2025."

The treosulfan NDA seeks approval of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adult and pediatric patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

About Medexus Pharmaceuticals Inc.

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of oncology, hematology, rheumatology, auto-immune diseases, allergy and dermatology. For more information about Medexus and its product portfolio, please see the company's corporate website and its filings on SEDAR+.

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