US FDA grants conditional approval to the brand name of Dimerix's DMX-200

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Dimerix (ASX:DXB) has announced that the US FDA has given conditional approval for the brand name QYTOVRA for its Phase 3 clinical drug candidate.

The candidate, formerly known as DMX-200, is being developed for focal segmental glomerulosclerosis (FSGS).

The company said the trademark for QYTOVRA has also been accepted and registered in Europe, the UK, Australia, China, Japan, and the Republic of Korea, with applications pending in the US and Canada.

“As our potential new treatment for this rare kidney disease moves closer to market, the name DMX-200 for FSGS had been replaced by the intended commercial brand name QYTOVRA," said Dimerix CEO and managing director Dr Nina Webster.

"The potential commercial value of QYTOVRA continues to increase as we successfully execute on each element of the development program. We have surpassed our first 72 patients randomised into this Phase 3 trial, as we move towards the outcome of Part 1 analysis in March 2024.

"In parallel, we continue to engage with the FDA, EMA and NMPA as well as prospective marketing partners. We are excited about the prospect of making this unique product available to patients in all major markets and, in doing so, deliver strong financial returns back to Dimerix and its investors,” added Dr Webster.