Quoin seeks SFDA breakthrough designation; QRX003 could be first approved Netherton treatment in 2H2026

Quoin Pharmaceuticals, Ltd.

Filed application with Saudi FDA for Breakthrough Medicine Designation for QRX003 for Netherton Syndrome.
If granted, QRX003 could be approved for sale/reimbursement in Saudi Arabia by 2H 2026, first-ever approved treatment for Netherton Syndrome.
Two pivotal trials for QRX003 lotion (4%) enrollment expected to complete 1H 2026; top-line data in 2H 2026.
NDA submission planned in US and other territories in late 2026/early 2027, subject to clinical outcomes.
As of Jan 20, 2026, Quoin has 1,616,179 ADSs outstanding.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.