Quoin Pharma gets FDA clearance to start second pivotal Netherton Syndrome study for QRX003

Quoin Pharmaceuticals, Ltd.

FDA cleared Study CL-QRX003-002, testing whole-body QRX003 (~80% BSA) with off-label systemic therapy in ~12-15 subjects.
Complements monotherapy pivotal study CL-QRX003-003 led by Dr. Amy Paller at Northwestern with up to 6 international sites.
Five U.S. sites open; sixth expected in June; all sites have subject cohorts ready for rapid enrollment.
Targets full recruitment into both pivotal studies by Q1 2026 and NDA filing later in 2026.
Quoin claims only company running two late-stage whole-body pivotal NS studies.

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