This week, DXB, our 2021 Biotech Pick of the Year, signed a third licensing deal for its FSGS clinical trial, targeting a rare kidney disease. This deal, worth up to $107M plus royalty sales, is for the Japan region. DXB is just 8 months away from potentially securing accelerated FDA approval to sell this product. The company has yet to find partners in two key markets: the US and China.
DXB announced during the holiday period that the crucial 144th patient had been recruited, randomised, and dosed, which is the last patient needed to take DXB through to the 'interim analysis results'. A crucial timeframe is set for August 2025, when DXB will complete its clinical trial and publish the results shortly afterwards. These results will determine if DXB is eligible for conditional or accelerated approval to sell its treatment.
What’s Next for DXB?
- Complete recruitment and dosing of 144 patients: As announced on the 30th December last year, this has now been complete.
- Complete recruitment and dosing of 286 patients: Full study recruitment is expected to be complete Q3 2025.
- Second interim results announced: The second interim analysis results will provide much more information about the efficacy of the DMX-200 drug, showing how effective the treatment is against FSGS using key biomarkers.
- Accelerated approvals granted: If the results are successful, DXB is expected to move quickly towards accelerated approvals.
- Drug pricing announced for DMX-200: An important factor for the DXB story is the drug pricing, which is generally set by negotiations between payers and providers.
- China commercialisation deal: China is a big market for FSGS with over 100,000 potential patients.
- USA commercialisation deal: This is the big one. If DXB is able to sign a commercialisation agreement with the US, it will be the most lucrative deal that the company signs.
