Quoin Pharmaceuticals Ltd. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Item 7.01. Regulation FD Disclosure.
On June 4, 2026, Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that Japan’s Ministry of Health, Labour and Welfare (“MHLW”) has granted Orphan Drug Designation to QRX003 lotion (4%) 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 Orphan Drug Designation from Japan’s MHLW for QRX003 lotion (4%) for the Treatment of Netherton Syndrome
On March 11, 2026, the Company announced that Japan’s MHLW has granted Orphan Drug Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome, a rare and severe genetic skin disorder for which there are currently no approved treatments.
The MHLW grants Orphan Drug Designation to medicines intended to treat rare diseases that affect fewer than 50,000 patients in Japan and for which there is high unmet medical need. The designation provides certain development incentives, including prioritized consultation, reduced consultation and application fees, tax incentives, priority review of applications, and up to 10 years of market exclusivity upon approval.
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 4, 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 4, 2026 | QUOIN PHARMACEUTICALS LTD. | |
| By: | /s/ Michael Myers | |
| Name: | Dr. Michael Myers | |
| Title: | Chief Executive Officer | |