Quoin Pharmaceuticals Announces FDA Rare Pediatric Designation for QRX003

What Happened

• On September 8, 2026, Quoin Pharmaceuticals, Ltd. (QNRX) announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) designation for its investigational product candidate QRX003 for the treatment of Peeling Skin Syndrome (PSS). The company filed a Current Report on Form 8-K on September 10, 2026 that includes the press release announcing the designation.

Key Details

• Announcement date: September 8, 2026; 8-K filed September 10, 2026 (press release attached as Exhibit 99.1).
• FDA granted RPD designation specifically for QRX003 in Peeling Skin Syndrome (PSS).
• This is QRX003’s second RPD designation; the first was previously granted for Netherton Syndrome.
• Company stated the designation “reinforces the potential of QRX003 as a therapeutic candidate for a profoundly underserved pediatric population.”

Why It Matters

• The RPD designation is a formal regulatory recognition that QRX003 targets a rare pediatric condition, underscoring Quoin’s focus on pediatric dermatologic disorders. For investors, this is a sign of regulatory progress for the company’s lead asset, which could influence the program’s development priorities and visibility. The filing is informational; it does not provide clinical data, timelines, or financial impacts.