The first patient with FSGS was recruited into the pivotal study in May 2022. In February 2024, proteinurea data from the first 72 patients treated for 35 weeks had been collected. The next month, the company announced that blinded analysis indicated that a clinically meaningful and statistically significant result was possible from that data set.
In December last year, the company announced that the 144th patient had been recruited into the study. The 35-week data from these patients is now available for blinded analysis, pending FDA discussions on what should be assessed. The final patient of a total 286 patients is expected to be recruited by the end of this year. Patients in the study are treated for two years. After that, all subjects are invited into the open-label extension study. In September last year, the first patient entered the open-label extension study, with 56 patients electing to continue treatment with DMX-200.
Summary
Dimerix has secured four licensing deals for DMX-200, generating upfront payments totalling $66 million with a total potential deal value of up to $1.4 billion. Assuming a selling price of US$9,000 per month for DMX-200, the potential market in the regions where Dimerix has secured licensing deals is valued at $1.2 billion a year. In the main regions, Dimerix also stands to receive royalties of between 13%-20% from drug sales.
Dimerix is capitalized at $307 million.
Bioshares recommendation: Speculative Buy Class A.
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