Form 8-K Quoin Pharmaceuticals For: Sep 08
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On September 8, 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 Rare Pediatric Disease (RPD) Designation for QRX003, the Company’s investigational product candidate, for the treatment of Peeling Skin Syndrome (PSS). 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 (the “SEC”) 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 8.01. Other Events.
Announcement of FDA Granting Rare Pediatric Disease Designation for QRX003 in Peeling Skin Syndrome
On September 8, 2026, the Company announced that the FDA has granted Rare Pediatric Disease (RPD) Designation for the Company’s lead asset, QRX003, for the treatment of Peeling Skin Syndrome (PSS). The Company believes that the designation reinforces the potential of QRX003 as a therapeutic candidate for a profoundly underserved pediatric population. This is the second RPD designation granted for QRX003, following the previously granted RPD designation for Netherton Syndrome.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
The following exhibits are filed or furnished, as applicable, with this Report:
| Exhibit Number |
Description | |
| 99.1 | Press Release of the Company, dated September 8, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| Date: September 10, 2026 | QUOIN PHARMACEUTICALS LTD. | |
| By: | /s/ Michael Myers | |
| Name: | Dr. Michael Myers | |
| Title: | Chief Executive Officer | |
ATTACHMENTS / EXHIBITS
XBRL TAXONOMY EXTENSION SCHEMA
XBRL TAXONOMY EXTENSION LABEL LINKBASE