FDA grants fast track designation for QRX003 in peeling skin syndrome

Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) announced on September 22, 2026 that the U.S. Food and Drug Administration had granted Fast Track Designation to QRX003 for the treatment of Peeling Skin Syndrome. The company said it is the first Fast Track Designation granted for a Peeling Skin Syndrome therapy. Peeling Skin Syndrome is a rare genetic skin disease with no approved treatment.

The designation is the second Fast Track Designation for QRX003. The FDA granted Fast Track Designation to QRX003 lotion (4%) for Netherton Syndrome on March 11, 2026.

The IND history

Quoin submitted its Investigational New Drug application for QRX003 in Peeling Skin Syndrome on June 2, 2026. The release says it was the first IND ever submitted to the FDA for the disease. The FDA cleared the application in July 2026.

The submission was supported by clinical observations from an ongoing investigator-led pediatric study in a single subject. The release says the subject has shown significant improvements in skin appearance, along with changes in pruritus and several quality-of-life measures. Treatment has continued for more than 15 months, and no adverse events have been reported.

The planned study

Quoin expects to start a Phase 2/3 study of QRX003 in Peeling Skin Syndrome in the second half of 2026. The study is expected to enroll up to 12 pediatric and adult patients in the United States and Europe. QRX003 would be applied twice daily to more than 80% of the patients' body surface area over a 48-week period, with an interim data review at 24 weeks.

Chief Executive Dr. Michael Myers said: "We expect to initiate our Phase 2/3 study in the second half of 2026, and we believe Fast Track status will allow us to work closely with the agency as we advance the first company-sponsored clinical study in this disease." The release says Quoin is targeting approval of QRX003 as a potential treatment for Peeling Skin Syndrome in 2028.

The release explains what the designation provides. The FDA's Fast Track program is designed to facilitate development and expedite review of drugs for serious conditions with an unmet medical need. A designated therapy may receive more frequent interactions with the FDA and eligibility for rolling review of submissions. It may also qualify for Accelerated Approval and Priority Review, if the relevant criteria are met.

Company background and finances

Quoin's annual report for 2025, filed March 26, 2026, says QRX003 is also being developed as a potential treatment for Peeling Skin Syndrome, with the first subject treated in New Zealand. The company is expanding that study to include up to an additional five pediatric subjects.

The annual report shows research and development expense of $9.8 million for 2025, up from $3.6 million for 2024. It reports a net loss of $15.8 million for 2025 and $9.0 million for 2024. Cash from operations was negative $13.5 million in 2025 and negative $7.9 million in 2024.

What the designation does not mean

Fast Track status speeds communication with the FDA. It is not evidence that QRX003 works in Peeling Skin Syndrome. The only clinical support the release offers is one pediatric subject in an investigator-led study, described by the company as showing significant improvements in that one subject, and no adverse events reported. The planned Phase 2/3 study of up to 12 patients has not started, and the release gives no date beyond the second half of 2026. The 2028 approval target is the company's own, and the release gives no date for a marketing application.

The annual report says no products have been commercialized and no revenue has been generated. Cash used in operations was $13.5 million in 2025, and the quarterly report shows cash and cash equivalents of $3.8 million and short-term investments of $7.0 million at June 30, 2026.

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