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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 14, 2026
| QUOIN
PHARMACEUTICALS LTD. |
| (Translation of registrant’s name into English) |
| State of Israel |
|
001-37846 |
|
92-2593104 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
|
42127 Pleasant Forest Court
Ashburn, VA |
|
20148-7349 |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (703) 980-4182
| Not applicable |
| (Former name or former address, if changed since last report) |
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered
pursuant to Section 12(b) of the Act:
| Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange on which registered |
American Depositary Shares, each
representing Thirty-five (35) Ordinary
Shares, no par value per share |
|
QNRX |
|
The Nasdaq Stock Market LLC |
| Ordinary Shares, no par value per share* |
|
|
|
N/A |
| * | Not for trading, but only in connection with the registration of the American Depositary Shares pursuant
to requirements of the Securities and Exchange Commission. |
Indicate by check
mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01. Regulation
FD Disclosure.
On October 14, 2026,
Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that its lead product
candidate QRX003 has been granted Orphan Drug Designation in Europe by the European Medicines Agency (the “EMA”) 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 8.01. Other Events.
EMA Grants Orphan Drug Designation to QRX003 for Treatment of Peeling
Skin Syndrome
On October 14, 2026,
the Company announced that its lead product candidate QRX003 has been granted Orphan Drug Designation in Europe by the EMA for the treatment
of Peeling Skin Syndrome.
Orphan Drug Designation
in Europe affords the Company incentive benefits including scientific advice on study protocols, various fee reductions and access to
EU grants. If approved for marketing by the European Medicines Agency, QRX003 will be granted 10 years of market exclusivity in Europe
with respect to similar medicines for the treatment of Peeling Skin Syndrome.
The Company intends to
initiate the first-ever formal clinical study for Peeling Skin Syndrome before year end.
Item 9.01. Financial
Statements and Exhibits.
The following exhibits
are filed or furnished, as applicable, with this Report:
Exhibit
Number |
|
Description |
| |
|
|
| 99.1 |
|
Press
Release of the Company, dated October 14, 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: October 14, 2026 |
QUOIN PHARMACEUTICALS LTD. |
| |
|
| |
By: |
/s/ Michael Myers |
| |
Name: |
Dr. Michael Myers |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
Quoin
Pharmaceuticals Announces European Medicines Agency (EMA) Grants Orphan Drug Designation for QRX003 for the Treatment of Peeling
Skin Syndrome
–
Company on track to initiate first-ever formal clinical trial in Peeling Skin Syndrome before year end
–
Orphan Drug designation milestone provides 10 years of market exclusivity for Peeling Skin Syndrome in Europe after receipt of marketing
authorization in the European Union
–
Designation Represents Eighth Important Regulatory Milestone for QRX003
–
QRX003 has also been granted Pediatric Rare Disease Designation and Fast Track Designation for Peeling Skin Syndrome from US Food and
Drug Administration
–
In Netherton Syndrome, QRX003 has been granted Orphan Drug Designation in US, Europe and Japan as well as Pediatric Rare Disease and
Fast Track Designations in the US
ASHBURN, Va., October 14,
2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical
stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces that its lead product candidate QRX003 has
been granted Orphan Drug Designation in Europe by the European Medicines Agency (EMA) for the treatment of Peeling Skin Syndrome.
Orphan Drug Designation
in Europe affords the Company incentive benefits including scientific advice on study protocols, various fee reductions and access to
EU grants. If approved for marketing by the EMA, QRX003 will be granted 10
years of market exclusivity in Europe with respect to similar medicines for the treatment of Peeling Skin Syndrome.
Quoin
CEO, Dr. Michael Myers, said, “We continue to make important clinical and regulatory progress for QRX003, both as a potential treatment
for Netherton Syndrome and Peeling Skin Syndrome, and this milestone marks yet another significant step forward for Quoin. Cumulatively
across both indications, QRX003 has now been granted four Orphan Drug designations by three major regulatory agencies, two Pediatric Rare
Disease Designations from the US FDA as well as Fast Track Status for both indications in the US. These eight important regulatory milestones
reflect both the innovative nature of the product and the recognition of the unmet medical needs it is targeting. We are on track to initiate
the first-ever formal clinical study for Peeling Skin Syndrome, a severe rare skin disease that has long been underserved.”
QRX003 is also currently
being evaluated in late-stage clinical trials for Netherton Syndrome, a severe and devastating, life-altering rare disease for which there
are currently no approved therapies.
About Quoin Pharmaceuticals
Ltd.
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 comprises four products in development that collectively have the potential to target a broad number
of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma,
Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit:
www.quoinpharma.com or LinkedIn for updates.
Cautionary Note Regarding
Forward Looking Statements
The Company cautions
that statements in this press release that are not descriptions of historical facts are forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing
future events or circumstances, such as “expect,” “intend,” “hope,” “plan,” “potential,”
“anticipate,” “look forward,” “believe,” “may,” and “will,” among others.
All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than
statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: the Company being
on track to initiate first-ever formal clinical trial in Peeling Skin Syndrome before year end; QRX003 as a potential treatment for Netherton
Syndrome and Peeling Skin Syndrome; advancing QRX003 in Quoin’s late-stage Netherton Syndrome and Peeling Skin Syndrome clinical
studies: upon marketing authorization being granted 10 years of market exclusivity in Europe for the treatment of Peeling Skin Syndrome,
and Quoin’s products in development collectively having the potential to target a broad number of rare and orphan indications, including
Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic
Malformations, Venous Malformations, Angiofibroma and others. Because such statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon
the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results
and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks
and uncertainties including, but not limited to, the Company’s ability to pursue its regulatory strategy including initiating the
first ever formal clinical trial in Peeling Skin Syndrome before year end; the Company’s ability to continue to meet the requirements
for orphan drug designation and to obtain ten years of market exclusivity in Europe with respect to similar medicines for the treatment
of Peeling Skin Syndrome; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to
comply with ongoing regulatory requirements; the Company’s ability to complete clinical trials on time and achieve desired results
and benefits as expected; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31,
2025 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking
statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
For further information,
contact:
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
