Quoin Pharmaceuticals' (QNRX) investigational candidate for the treatment of Netherton Syndrome has received US Food and Drug Administration conditional approval to use the brand name Qyleki for QRX003, the company said Tuesday.
The FDA has also granted the drug fast track and rare pediatric disease designations, and a phase 3 study is expected to begin in H2 2026, the company said.
Quoin expects to file a potential new drug application in 2027, the company said.
Netherton Syndrome is a rare, inherited skin ailment caused by a gene mutation and can lead to severe skin dysfunctions.
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