Discover more about Medexus’ exciting opportunity with their Treosulfan pipeline, potentially doubling revenues upon US commercialization approval. Treosulfan, a novel conditioning treatment for allogeneic hematopoietic stem cell transplantation (allo-HSCT), gained approval from Health Canada in June 2021, launching commercially as Trecondyv®.

What’s new here is that Medexus just announced the FDA’s acceptance of the Treosulfan NDA for review, expecting a decision by October 30th, 2024. If approved, Medexus stands to swiftly launch Treosulfan to the US market, where they estimate the current leading product generated ~US$126 million in peak annual revenue before genericization in 2018.

This development is an important revenue indicator for Medexus, highlighted by the Phase 3 clinical trial of Treosulfan, published in the American Journal of Hematology. The study demonstrates Treosulfan’s clinical superiority over the widely used "reduced-intensity conditioning" busulfan regimen. Notably, Treosulfan showcased a 36% reduction in events, establishing its superiority in event-free survival, the primary endpoint of the trial.

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