Quoin Pharmaceuticals Says US FDA Clears Second Netherton Syndrome Pivotal Study

MT Newswires Live
2025/05/22

Quoin Pharmaceuticals (QNRX) said Thursday that it has received US Food and Drug Administration clearance to initiate a second whole-body clinical study evaluating QRX003 topical lotion as a potential therapy for Netherton Syndrome, a condition that causes excessive skin shedding.

The company said that clinical data has shown "clear evidence of rapid, prolonged and almost complete skin healing" as well as "almost complete" elimination of symptoms following twice daily application of the topical ointment.

In the coming study, QRX003 will be applied to 12 to 15 subjects twice daily to at least 80% of their skin, the company said.

Along with another ongoing study, the company said it estimates that between 24 and 30 patients will be recruited in the US and at up to 6 international sites.

The company said it hopes to complete recruitment by the end of Q1 2026 and file a new drug application later in 2026.

Shares of the company were up more than 7% in recent premarket activity.

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