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

Rhea-AI Filing Summary

Quoin Pharmaceuticals (NASDAQ:QNRX), a late clinical-stage specialty pharmaceutical company, announced that the FDA has granted Rare Pediatric Disease (RPD) Designation for their lead asset QRX003, targeting Netherton Syndrome. This significant regulatory milestone was disclosed in an 8-K filing dated June 24, 2025.

The RPD designation for QRX003 represents an important development in the company's rare and orphan disease pipeline, potentially accelerating the path to market for their Netherton Syndrome treatment.

Positive

• FDA granted Rare Pediatric Disease Designation for lead asset QRX003
• Potential eligibility for valuable Priority Review Voucher upon approval
• Strategic advancement in rare disease treatment development

Negative

• Still in late clinical-stage with no approved products

Insights

Regulatory Affairs Specialist

RPD designation strengthens QRX003's market position and could expedite its development pathway for Netherton Syndrome treatment.

The FDA's grant of Rare Pediatric Disease Designation for QRX003 is strategically significant. This designation can lead to a Priority Review Voucher upon drug approval, which carries substantial value - either for accelerating future reviews or as a tradeable asset worth potentially hundreds of millions. The designation also validates the unmet medical need in pediatric Netherton Syndrome patients and suggests the FDA recognizes the potential therapeutic impact of QRX003.

Biotech Investment Analyst

RPD designation enhances QRX003's commercial potential and adds significant strategic optionality for Quoin.

The RPD designation represents a material regulatory milestone that could significantly enhance QRX003's market potential. For a late clinical-stage company, securing this designation for a lead asset targeting a rare disease indicates strong positioning in the orphan drug space. The potential for a Priority Review Voucher upon approval adds substantial non-dilutive value potential, either through future use or monetization. This development strengthens Quoin's strategic position in the rare disease market.

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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 24, 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 8.01. Other Events.

Quoin Pharmaceuticals Ltd. (the “Company” or “Quoin”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, announced on June 24, 2025 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 Netherton Syndrome.

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 25, 2025	QUOIN PHARMACEUTICALS LTD.
	By:	/s/ Michael Myers
	Name:	Dr. Michael Myers
	Title:	Chief Executive Officer

FAQ

What is the significance of the FDA's Rare Pediatric Disease Designation for QNRX's QRX003?

The RPD designation is significant as it can lead to a Priority Review Voucher upon approval, potentially expediting the review process or providing value through sale. It also validates the unmet medical need in pediatric Netherton Syndrome.

What condition does QNRX's QRX003 target?

QRX003 is being developed for the treatment of Netherton Syndrome, a rare pediatric disease.

What is QNRX's current development stage?

Quoin Pharmaceuticals is currently a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases.

Who is leading QNRX's development efforts?

The company is led by Dr. Michael Myers, who serves as the Chief Executive Officer.