Form 8-K

8-K — Quoin Pharmaceuticals Ltd.

Accession: 0001104659-26-109639

Filed: 2026-09-22

Period: 2026-09-22

CIK: 0001671502

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2625948d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2625948d1_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 22, 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 22,

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 Fast Track Designation to QRX003, the Company’s investigational product

candidate, 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.

Announcement of FDA Granting Fast Track Designation to QRX003 for

Treatment of Peeling Skin Syndrome

On September 22,

2026, the Company announced that the FDA has granted Fast Track Designation to the Company’s lead asset, QRX003, for the treatment

of Peeling Skin Syndrome. The Company believes that the designation will allow it to work closely with the FDA to advance the first company-sponsored

clinical study in this disease. This is the second Fast Track Designation granted to QRX003, following the previously grant of Fast Track

Designation for the treatment of 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 22, 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 22, 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: tm2625948d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Quoin

Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling Skin Syndrome

– First-Ever

Fast Track Designation Granted for a Peeling Skin Syndrome Therapy

– Second

Fast Track Designation Granted to QRX003, in Addition to Netherton Syndrome

– Fast

Track Designation Facilitates Development and Expedites Regulatory Review of Therapies Addressing

Serious Conditions with Significant Unmet Medical Need

– Follows

July 2026 FDA Clearance of the First-Ever IND Submitted for Peeling Skin Syndrome

– Phase

2/3 Study Expected to Initiate in 2H 2026, Enrolling up to 12 Pediatric and Adult Patients

in the U.S. and Europe

– Peeling

Skin Syndrome Currently Has No Approved Treatment

ASHBURN,

Va., Sept. 22, 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 Fast Track Designation to QRX003 for the treatment of Peeling Skin Syndrome (PSS). QRX003 is an investigational

topical serine protease inhibitor lotion. Peeling Skin Syndrome is a rare genetic skin disease for which there is currently no approved

treatment.

Key

Facts

· Fast

Track Designation applies to QRX003 for the treatment of Peeling Skin Syndrome.

· This

is the first ever Fast Track Designation granted for a Peeling Skin Syndrome therapy.

· Peeling

Skin Syndrome is the second indication for which QRX003 has received Fast Track Designation.

The FDA granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton

Syndrome on March 11, 2026.

· The

designation follows FDA clearance in July 2026 of Quoin’s Investigational New

Drug (IND) application for QRX003 in Peeling Skin Syndrome. Quoin submitted that IND on June 2,

2026, and it was the first IND ever submitted to the FDA for the disease.

· Quoin

expects to initiate a Phase 2/3 clinical study of QRX003 in Peeling Skin Syndrome in the

second half of 2026.

· The

IND submission was supported by clinical observations from an ongoing investigator-led pediatric

study in a single subject. Significant improvements in skin appearance along with positive

changes in pruritus and a number of quality-of-life measures have been recorded. Treatment

is ongoing and has continued for more than 15 months, with no adverse events reported.

· There

is currently no approved treatment for Peeling Skin Syndrome.

“This

is an important regulatory milestone for QRX003 and for a community that today has no approved treatment,” said Dr. Michael

Myers, CEO and Co-Founder of Quoin Pharmaceuticals. “Quoin submitted the first IND ever filed with the FDA for Peeling Skin Syndrome,

that IND was cleared in July, and QRX003 has now been granted Fast Track Designation for the disease. We expect to initiate our Phase

2/3 study in the second half of 2026, and we believe Fast Track status will allow us to work closely with the agency as we advance the

first company-sponsored clinical study in this disease.”

Peeling

Skin Syndrome Development Program

The

planned Phase 2/3 study is expected to enroll up to 12 pediatric and adult patients with Peeling Skin Syndrome in the United States and

Europe. In the study, QRX003 will be applied twice-daily to greater than 80% of patients’ body surface area (BSA) over a 48-week

period, with an interim data review at 24 weeks. Quoin is targeting approval of QRX003 as a potential treatment for Peeling Skin Syndrome

in 2028.

The

IND submission was supported by clinical observations from an ongoing investigator-led pediatric study. The subject has achieved improvements

across key objective severity endpoints, including the Modified Ichthyosis Area Severity Index (M-IASI), Investigator’s Global

Assessment (IGA) as well as pruritus and a pediatric dermatology-specific quality-of-life measure (CDLQI). Treatment is ongoing, and

after continued dosing with QRX003 for over 15 months, no adverse events have been reported.

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

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

QRX003

is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin

diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration,

and Orphan Drug Designation in the European Union and Japan for Netherton Syndrome. QRX003 has also been granted Rare Pediatric Disease

and Fast Track Designation by the FDA for Peeling Skin Syndrome. QRX003 lotion (4%) is currently being evaluated in Phase 2/3 whole-body

clinical trials in patients with Netherton Syndrome. Quoin expects to initiate a Phase 2/3 clinical study of QRX003 in Peeling Skin Syndrome

in the second half of 2026.

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.

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. This press release contains forward-looking statements. 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: Fast Track Designation facilitating development and expediting regulatory review of therapies

addressing serious conditions with significant unmet medical need; plans to initiate a Phase 2/3 clinical study of QRX003 in Peeling

Skin Syndrome in the second half of 2026; Fast Track status allowing Quoin to work closely with the FDA to advance the first company-sponsored

clinical study in Peeling Skin Syndrome; the study expecting to enroll up to 12 pediatric and adult patients with Peeling Skin Syndrome

in the United States and Europe; QRX003 expected to be applied twice-daily to greater than 80% of a patients’ body surface area

over a 48-week period, with an interim data review at 24 weeks; targeting approval of QRX003 as a potential treatment for Peeling Skin

Syndrome in 2028; therapies granted Fast Track Designation benefiting 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; 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, Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis

Complex, 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 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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