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Current Report · Items 7.01, 8.01, 9.01 · 8-K

Quoin Pharmaceuticals Ltd.

Regulation FD Disclosure · Other Events

Item 7.01. Regulation FD Disclosure. On September 22, 2026, Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has granted Fast Track Designation to QRX003, the Company’s investigational product candidate, for the treatment of Peeling Skin Syndrome.…

Filed Sep 22, 2026Accepted Sep 22, 2026, 4:15 PM EDTCIK 1671502Accession 0001104659-26-109639
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Company context

Quoin Pharmaceuticals Ltd. Is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities, and care teams. Quoin’s innovative pipeline is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibromas and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.

Current securities

Historical securities (2)

Recent company filings

  1. PRE 14A filingSep 22, 2026
  2. S-3 filingSep 18, 2026
  3. D filingSep 10, 2026
  4. Regulation FD Disclosure · Other EventsSep 10, 2026
  5. 4 filingAug 28, 2026

Disclosure sections

Items 7.01, 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure. On September 22, 2026, Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has granted Fast Track Designation to QRX003, the Company’s investigational product candidate, for the treatment of Peeling Skin Syndrome. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (the “Report”) and is incorporated by reference herein. The information in this Item 7.01 and Exhibit 99.1 attached hereto is furnished and shall not be deemed to be “filed” with the Securities and Exchange Commission for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01Item 8.01 - Other Events
Item 8.01. Other Events. Announcement of FDA Granting Fast Track Designation to QRX003 for Treatment of Peeling Skin Syndrome On September 22, 2026, the Company announced that the FDA has granted Fast Track Designation to the Company’s lead asset, QRX003, for the treatment of Peeling Skin Syndrome. The Company believes that 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 Designation granted to QRX003, following the previously grant of Fast Track Designation for the treatment of Netherton Syndrome.
Filed exhibits (1)
EX-99.1 (by filename) tm2625948d1_ex99-1.htm

Exhibit 99.1 Quoin Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling Skin Syndrome First-Ever Fast Track Designation Granted for a Peeling Skin Syndrome Therapy Second Fast Track Designation Granted to QRX003, in Addition to Netherton Syndrome Fast Track Designation Facilitates Development and Expedites Regulatory Review of Therapies Addressing Serious Conditions with Significant Unmet Medical Need Follows July 2026 FDA Clearance of the First-Ever IND Submitted for Peeling Skin Syndrome ───────────────────────────────────────────────────────────────────────────────────── Phase 2/3 Study Expected to Initiate in 2H 2026, Enrolling up to 12 Pediatric and Adult Patients in the U.S. and Europe Peeling Skin Syndrome Currently Has No Approved Treatment ASHBURN, Va., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to QRX003 for the treatment of Peeling Skin Syndrome

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