Quoin Pharmaceuticals (QNRX) said Thursday that Japan's Ministry of Health, Labour and Welfare has granted orphan drug designation to its experimental drug, QRX003, for the treatment of Netherton Syndrome.
The company said the designation provides development incentives such as regulatory support, reduced fees, priority review, tax benefits, and up to 10 years of market exclusivity if approved.
QRX003 is currently being evaluated in mid-stage studies, with a pivotal late-stage trial expected to begin in H2, Quoin said, adding that a US regulatory filing could follow next year.
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