[8-K] Quoin Pharmaceuticals, Ltd. Reports Material Event

Rhea-AI Filing Summary

Quoin Pharmaceuticals (QNRX) announced that the FDA granted Orphan Drug Designation (ODD) to its lead candidate QRX003 for treating Netherton Syndrome. This follows ODD from the EMA in May 2025.

ODD provides benefits such as tax credits for qualified clinical testing, waiver or partial payment of FDA application fees, and seven years of U.S. market exclusivity if approved. QRX003 lotion (4%) is in two late‑stage, whole‑body pivotal trials.

Quoin expects enrollment in both pivotal studies to complete in the first quarter of 2026, with top‑line data in the second half of 2026, and an NDA submission planned later in the year.

Insights

Biotech regulatory analyst

FDA ODD adds incentives and potential 7-year exclusivity, pending approval.

Orphan Drug Designation supports development for rare diseases and can lower costs via tax credits and application fee relief. It also confers seven years of U.S. market exclusivity upon approval, which can enhance post-approval protection for QRX003 in Netherton Syndrome.

QRX003 is already in two late-stage pivotal studies, suggesting a defined path toward potential filing. The company outlines operational milestones: enrollment completion by Q1 2026, top-line data in H2 2026, and an NDA planned later in 2026.

Actual outcomes depend on pivotal results and regulatory review. The designation itself does not imply efficacy or approval; it provides incentives and a potential exclusivity framework if approval is obtained.

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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 21, 2025

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 21, 2025, Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has granted Orphan Drug Designation to the Company’s lead product candidate, QRX003, 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.

On October 21, 2025, the Company announced that the FDA has granted Orphan Drug Designation to the Company’s lead product candidate, QRX003, for the treatment of Netherton Syndrome. The designation follows previously granted Orphan Drug Designation by the European Medicines Agency (the “EMA”) in May 2025.

The FDA’s Orphan Drug Designation program provides orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the United States. This designation provides certain benefits, including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees and seven years of market exclusivity, if approved. QRX003 is on track to potentially become the first approved treatment for Netherton Syndrome.

QRX003 lotion (4%) is being evaluated in two late-stage whole body pivotal clinical trials for Netherton Syndrome. Enrollment in both pivotal studies is expected to be completed in the first quarter of 2026, top-line data is anticipated in the second half of 2026, and a new drug application (“NDA”) submission is planned later in the year.

Cautionary Note Regarding Forward Looking Statements

The Company cautions that statements in this Report 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: QRX003 being on track to potentially become the first approved treatment for Netherton Syndrome, the progress of the Company’s clinical trials, and the timing of trial results and regulatory submissions. 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 timing of the Company’s clinical studies may be delayed 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.

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 October 21, 2025
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 21, 2025	QUOIN PHARMACEUTICALS LTD.
	By:	/s/ Michael Myers
	Name:	Dr. Michael Myers
	Title:	Chief Executive Officer

FAQ

What did Quoin Pharmaceuticals (QNRX) announce?

The FDA granted Orphan Drug Designation to QRX003 for treating Netherton Syndrome, following EMA ODD in May 2025.

What benefits come with FDA Orphan Drug Designation for QNRX?

Benefits include tax credits for qualified clinical testing, fee waivers or partial payments, and seven years of U.S. market exclusivity if approved.

What stage are QRX003 clinical trials in?

QRX003 lotion (4%) is in two late-stage whole body pivotal clinical trials for Netherton Syndrome.

What is the QRX003 clinical timeline disclosed by QNRX?

Enrollment completion is expected in Q1 2026, top-line data in the second half of 2026, and an NDA submission is planned later in 2026.

Does Orphan Drug Designation mean QRX003 is approved?

No. ODD provides incentives and potential exclusivity, but approval is required to market QRX003.

What condition is QRX003 targeting?

QRX003 targets Netherton Syndrome, a rare disease for which ODD criteria include affecting fewer than 200,000 people in the U.S.