Form 8-K

8-K — Quoin Pharmaceuticals, Ltd.

Accession: 0001104659-26-076822

Filed: 2026-06-23

Period: 2026-06-23

CIK: 0001671502

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2618505d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2618505d1_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):

June 23, 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 June 23, 2026,

Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that the U.S. Food and

Drug Administration (the “FDA”) has conditionally approved QYLEKI™ as the proposed brand name for QRX003, the Company’s

investigational product candidate 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 Conditional

Approval of QYLEKI™ as the Proposed Brand Name for QRX003 for Netherton Syndrome

On June 23, 2026,

the Company announced that the FDA has conditionally approved QYLEKI™ as the proposed brand name for QRX003, the Company’s

investigational product candidate for the treatment of Netherton Syndrome. The proposed name QYLEKI (pronounced “Key-Lek-ee”)

was developed in accordance with the FDA’s guidance on proprietary names. The Company further stated that FDA acceptance of the

Company’s proposed brand name represents a milestone for the Company as it executes on its mission to deliver the first approved

treatment for Netherton Syndrome. The Company expects to include a request for proprietary name review and final approval for QYLEKI in

a New Drug Application (NDA) for QRX003.

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 23, 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 23, 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: tm2618505d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Quoin Pharmaceuticals

Receives FDA Conditional Approval of QYLEKI™ as the Proposed Brand Name for QRX003 for Netherton Syndrome

- QRX003

Holds Orphan Drug Designation in the United States, the European Union, and Japan, Plus Fast

Track and Rare Pediatric Disease Designations from the FDA

- Pivotal

Phase 3 Study Expected to Initiate in the Second Half of 2026, with Potential NDA Filing

in 2027

- Positive

Clinical Update from Ongoing Pediatric Compassionate Use Program Released on June 16

- QRX003

remains on track to Potentially Become the First Approved Treatment for Netherton Syndrome

ASHBURN, Va., June 23, 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 conditionally approved QYLEKI™ as the proposed brand name for QRX003, the Company’s investigational product candidate

for the treatment of Netherton Syndrome. FDA acceptance of the Company’s proposed brand name represents yet another important milestone

for Quoin as it executes on its mission to deliver the first approved treatment for Netherton Syndrome. A request for proprietary name

review and final approval for QYLEKI will be included in a New Drug Application (NDA) for QRX003.

Key Facts

· The

FDA has conditionally accepted QYLEKI™ as the proposed brand name for QRX003, Quoin's

investigational topical treatment for Netherton Syndrome.

· QRX003

holds Orphan Drug Designation in the United States, the European Union, and Japan.

· The

FDA has also granted QRX003 Fast Track and Rare Pediatric Disease Designations.

· Quoin's

pivotal Phase 3 study is expected to initiate in the second half of 2026.

· A

potential NDA filing is anticipated in 2027.

· There

is currently no approved treatment for Netherton Syndrome. If approved, QRX003 could become

the first.

The proposed name QYLEKI (pronounced

“Key-Lek-ee”) was developed in accordance with the FDA’s guidance on proprietary names. Final approval of the QYLEKI

brand name will be obtained upon FDA marketing approval of QRX003.

“The designation of a brand name

for the first potentially approved treatment for Netherton Syndrome represents another important step for Quoin, our commercial partners

and most importantly, the Netherton community as a whole.” said Dr. Michael Myers, Chief Executive Officer and Co-Founder

of Quoin Pharmaceuticals. “FDA conditional approval of the QYLEKI brand name reflects the continued progress we are making toward

potential commercialization of the product and complements the regulatory recognition the product has received in the United States,

Europe, and Japan. Having just released a positive update from our ongoing Pediatric Compassionate Use Program and with our pivotal Phase

3 study expected to commence later this year, this is an extremely exciting time for Quoin as we remain fully focused on delivering QYLEKI

to patients as what could be the first approved treatment for Netherton Syndrome.”

QYLEKI Development and Regulatory

Status

QYLEKI lotion (4%) is currently being

evaluated in Phase 2 whole-body clinical trials in patients with Netherton Syndrome. Quoin’s pivotal Phase 3 study is expected

to initiate in the second half of 2026, with a potential NDA filing in 2027. QYLEKI has received Orphan Drug Designation in the United

States, the European Union, and Japan, along with Fast Track and Rare Pediatric Disease Designations from the FDA, providing regulatory

recognition across Quoin’s three core commercial territories.

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 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: QYLEKI being the proposed brand name for QRX003 for Netherton Syndrome; Quoin executing

on its mission to deliver the first approved treatment for Netherton Syndrome; initiating a pivotal Phase 3 study in the second half

of 2026 with a potential NDA filing anticipated in 2027; obtaining final approval of the QYLEKI brand name upon FDA marketing approval

of QRX003; continuing the progress being made toward potential commercialization of QRX003; delivering the first approved treatment for

Netherton Syndrome; 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, 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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