Quoin Pharmaceuticals Receives FDA Fast Track for QRX003 (Peeling Skin Syndrome)

What Happened
Quoin Pharmaceuticals Ltd. announced on September 22, 2026 (Form 8-K) that the U.S. Food and Drug Administration granted Fast Track designation to its lead investigational product QRX003 for the treatment of Peeling Skin Syndrome. The company said the designation will allow it to work closely with the FDA to advance the first company‑sponsored clinical study in this disease. This is the second Fast Track for QRX003, following an earlier Fast Track for Netherton Syndrome.

Key Details

• Event filed on Form 8-K dated September 22, 2026 (Items 7.01 and 8.01).
• Product: QRX003 — company’s lead asset.
• Indication: Peeling Skin Syndrome; this is the second FDA Fast Track for QRX003 (previously granted for Netherton Syndrome).
• Company statement: designation is expected to facilitate closer interaction with the FDA to advance the first company‑sponsored clinical study.
• Press release attached as Exhibit 99.1 to the 8-K.

Why It Matters
Fast Track designation is a formal FDA program intended to expedite the development and review of treatments for serious or life‑threatening conditions with unmet medical needs. For investors, the designation can mean earlier and more frequent communication with the FDA and potential access to accelerated regulatory pathways, which may speed development timelines and de‑risk regulatory engagement (though it does not guarantee approval). The news highlights QRX003 as Quoin’s lead clinical asset and signals regulatory momentum for the company’s pipeline.