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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):
March 11, 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 March 11, 2026,
Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that the U.S. Food and
Drug Administration (“FDA”) has granted Fast Track 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 Fast
Track Designation for QRX003 lotion (4%) for the Treatment of Netherton Syndrome
On March 11, 2026,
the Company announced that that the FDA has granted Fast Track 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 FDA's Fast Track
program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical
need. A therapy granted Fast Track Designation may benefit from more frequent interactions with the FDA, eligibility for rolling review
of regulatory submissions, and potential qualification for Accelerated Approval and Priority Review, if relevant criteria are met.
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 March 11, 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: March 11, 2026 |
QUOIN PHARMACEUTICALS LTD. |
| |
|
| |
By: |
/s/ Michael Myers |
| |
Name: |
Dr. Michael Myers |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
Quoin Pharmaceuticals Announces FDA Grants Fast Track Designation
for QRX003 for the Treatment of Netherton Syndrome
— Fast Track Designation facilitates development and expedites
regulatory review of therapies addressing serious conditions with significant unmet medical need —
— QRX003 lotion (4%) currently being evaluated in two late-stage
whole-body clinical trials for treatment of Netherton Syndrome —
— Fast Track Designation follows Pediatric Rare Disease and
Orphan Drug Designation previously granted by the FDA and Orphan Drug Designation granted by the European Medicines Agency for QRX003
in Netherton Syndrome —
ASHBURN, Va., March 11, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals
Ltd. (NASDAQ: QNRX) ("Quoin" or the "Company"), a late clinical-stage specialty pharmaceutical company focused on
developing and commercializing therapeutic products that treat rare and orphan diseases, today announced that the U.S. Food and Drug Administration
(FDA) has granted Fast Track 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.
"We believe that the FDA's decision to grant Fast Track Designation
to QRX003 reflects the urgent unmet need faced by patients and families living with Netherton Syndrome," said Dr. Michael Myers,
CEO and Co-Founder of Quoin Pharmaceuticals. "Fast Track status enables more frequent communication with the FDA and the potential
for accelerated regulatory review pathways, which may help bring the first approved treatment for Netherton Syndrome to patients as quickly
as possible."
QRX003 Development Program
QRX003 lotion (4%) is currently being evaluated in two late-stage whole-body
clinical trials designed to assess safety and efficacy in patients with Netherton Syndrome.
QRX003 previously received Orphan Drug Designation from both the U.S.
FDA and the European Medicines Agency (EMA) for the treatment of Netherton Syndrome, providing potential benefits including market exclusivity
upon approval, tax credits for clinical testing, and certain regulatory fee reductions. QRX003 has also been granted Pediatric Rare Disease
Designation by the FDA.
About Netherton Syndrome
Netherton Syndrome is a rare, inherited skin disorder caused by mutations
in the SPINK5 gene, leading to severe skin barrier dysfunction, chronic inflammation, and a heightened risk of infections and allergic
complications. Patients often experience widespread skin redness, scaling, persistent itching, and significant impairment in quality of
life. There are currently no FDA-approved therapies for the treatment of Netherton Syndrome, and treatment options are limited to supportive
care and off-label therapies.
About Fast Track Designation
The FDA's Fast Track program is designed to facilitate the development
and expedite the review of drugs that treat serious conditions and fill an unmet medical need. A therapy granted Fast Track Designation
may benefit from more frequent interactions with the FDA, eligibility for rolling review of regulatory submissions, and potential qualification
for Accelerated Approval and Priority Review, if relevant criteria are met.
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 several products
in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome,
Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, 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 a description 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,” “plan,” “anticipate,” “believe,” “look forward to,” 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 potential
for an accelerated regulatory review pathway for QRX003, bringing the first approved treatment for Netherton Syndrome to patients as quickly
as possible, timing of clinical studies, 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, Palmoplantar Keratoderma, Scleroderma, 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; the Company’s
ability to obtain regulatory approvals for the 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, 2024 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:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
