UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On June 23, 2026, Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has conditionally approved QYLEKI™ as the proposed brand name for QRX003, the Company’s investigational product candidate for the treatment of Netherton 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 are 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 Conditional Approval of QYLEKI™ as the Proposed Brand Name for QRX003 for Netherton Syndrome
On June 23, 2026, the Company announced that the FDA has conditionally approved QYLEKI™ as the proposed brand name for QRX003, the Company’s investigational product candidate for the treatment of Netherton Syndrome. The proposed name QYLEKI (pronounced “Key-Lek-ee”) was developed in accordance with the FDA’s guidance on proprietary names. The Company further stated that FDA acceptance of the Company’s proposed brand name represents a milestone for the Company as it executes on its mission to deliver the first approved treatment for Netherton Syndrome. The Company expects to include a request for proprietary name review and final approval for QYLEKI in a New Drug Application (NDA) for QRX003.
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 June 23, 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: June 23, 2026 | QUOIN PHARMACEUTICALS LTD. | |
| By: | /s/ Michael Myers | |
| Name: | Dr. Michael Myers | |
| Title: | Chief Executive Officer | |