Form 8-K

8-K — Quoin Pharmaceuticals Ltd.

Accession: 0001104659-26-106705

Filed: 2026-09-10

Period: 2026-09-08

CIK: 0001671502

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2625203d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2625203d1_ex99-1.htm)

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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):

September 8, 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 ¨

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 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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2625203d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Quoin Pharmaceuticals Announces FDA Grants Rare

Pediatric Disease Designation for QRX003 in Peeling Skin Syndrome

Second Rare Pediatric Disease (RPD) Designation for QRX003

FDA Previously Granted RPD Designation for QRX003 in Netherton Syndrome

If a New Drug Application (NDA) for QRX003 Is Approved for Peeling Skin Syndrome, Quoin May Receive a Freely Tradable Priority Review Voucher (PRV)

Quoin Expects to Initiate Phase 2 Study in 2H 2026; Study Plans to Enroll up to 12 Pediatric and Adult Peeling Skin Patients in the U.S. and Europe

There are Currently No Approved Treatments for Peeling Skin Syndrome

ASHBURN, Va., September 8, 2026 (GLOBE NEWSWIRE) -- Quoin

Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical

company focused on rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric

Disease (RPD) Designation for the Company’s lead asset, QRX003, for the treatment of Peeling Skin Syndrome (PSS).

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.

The FDA’s Rare Pediatric Disease Designation program is intended

to encourage the development of new therapies for serious and life-threatening diseases that primarily affect individuals under 18 years

of age. If a New Drug Application (NDA) for QRX003 is approved, Quoin may qualify to receive a Priority Review Voucher (PRV), which can

be redeemed to receive priority review for another marketing application or may be sold or transferred.

“We are very pleased to announce the receipt of Rare Pediatric

Disease Designation for QRX003 for Peeling Skin Syndrome,” said Dr. Michael Myers, Chief Executive Officer of Quoin Pharmaceuticals.

“With the IND cleared by FDA, the Quoin team is preparing to initiate the Phase 2 clinical study before the end of this year with

plans to enroll up to 12 pediatric and adult Peeling Skin patients in the U.S. and Europe. This will be the first formal study ever conducted

in the U.S. for this disease under an open IND.”

About Peeling Skin Syndrome (PSS)

Generalized inflammatory peeling skin syndrome (PSS) is a rare autosomal

recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (CDSN), resulting in excessive

shedding of the superficial layers of the epidermis. Patients generally suffer from a variety of conditions including severe pain and

chronic pruritus (itch). There is currently no approved treatment for PSS.

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 is focused on two key

platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and orphan indications, including

Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex,

Microcystic Lymphatic Malformations, Venous Malformations, Angiofibromas 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

of QRX003 as a therapeutic candidate for Peeling Skin Syndrome and a profoundly underserved pediatric population, Quoin’s eligibility

to receive Priority Review Vouchers upon approval of a New Drug Application for QRX003; the initiation of a Phase 2 clinical study for

Peeling Skin Syndrome before the end of 2026 with plans to enroll up to 12 pediatric and adult patients in the U.S. and Europe; and Quoin’s

belief that its products in development collectively have the potential to target a broad number of rare and orphan indications, including

Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex,

Microcystic Lymphatic Malformations, Venous Malformations, Angiofibromas 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 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:

Quoin Pharmaceuticals Ltd.

Michael Myers, Ph.D., CEO

mmyers@quoinpharma.com

Investor Relations

PCG Advisory

Jeff Ramson

jramson@pcgadvisory.com

(646) 863-6341

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