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Quoin Pharmaceuticals Files Breakthrough Medicine Designation Application in Saudi Arabia for QRX003 in Netherton Syndrome

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QRX003 could become the first ever approved treatment for Netherton Syndrome ASHBURN, Va., Jan. 20, ...

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Quoin Pharmaceuticals (QNRX) has filed for a Breakthrough Medicine Designation for QRX003, which targets Netherton Syndrome. If granted, it may accelerate regulatory review, potentially leading to its first approval for this condition, with patient access anticipated by late 2026 and a New Drug Application planned for 2027.

Sentiment Rationale

The positive development regarding QRX003's regulatory potential may reflect similarly to other biotech stocks that surged on breakthrough announcements.

Trading Thesis

Consider buying QNRX stock in anticipation of potential price movement upon designation approval news.

Market-Moving

  • Approval of Breakthrough designation may enhance QRX003's clinical and market profile.
  • Top-line trial data could influence investor confidence and stock price.
  • First-ever treatment approval for Netherton Syndrome could lead to substantial market interest.
  • Partnership developments with Genpharm may boost regional market access.

Key Facts

  • QNRX filed for Breakthrough Medicine Designation in Saudi Arabia.
  • QRX003 could be the first approved treatment for Netherton Syndrome.
  • Expected regulatory review acceleration following designation.
  • Top-line data from pivotal trials anticipated in late 2026.
  • QNRX targets unmet medical needs in rare diseases.

Companies Mentioned

  • Genpharm (N/A): Distribution partner for QRX003 in Saudi Arabia and MENA countries.

Corporate Developments

The news represents a crucial corporate development for Quoin Pharmaceuticals, particularly because it highlights a major regulatory milestone that can significantly impact the company's future revenue streams and market perception.

Quoin Pharmaceuticals Seeks Breakthrough Medicine Designation for QRX003 in Saudi Arabia

ASHBURN, Va., Jan. 20, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX), a late clinical-stage specialty pharmaceutical company, has filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003, its lead investigational topical product aimed at treating Netherton Syndrome. If approved, QRX003 could become the first-ever treatment for this debilitating condition worldwide.

Breakthrough Medicine Designation Overview

The SFDA's Breakthrough Medicine Designation program aims to accelerate the development and review of medicines addressing serious or life-threatening conditions that meet high unmet medical needs.

Key eligibility requirements for this designation include:

  • Targeting serious conditions with unmet medical need.
  • Potentially providing significant advantages over existing treatments.
  • A favorable benefit/risk balance where benefits outweigh potential adverse effects.
  • Not being registered with any regulatory authority at the time of submission.

Quoin Pharmaceuticals believes that QRX003 meets all the above criteria.

Potential Impact and Significance of QRX003

If granted, this designation would enable an accelerated regulatory review process, allowing early access to QRX003 in Saudi Arabia, potentially by the second half of 2026.

QRX003 has already earned both Orphan Drug and Pediatric Rare Disease Designations from the U.S. Food and Drug Administration, as well as Orphan Drug Designation from the European Medicines Agency.

Quoin has also established a distribution partnership with Genpharm for QRX003 in Saudi Arabia and other countries in the MENA region.

Leadership Commentary

Dr. Michael Myers, CEO of Quoin Pharmaceuticals, stated, “Filing for Breakthrough Medicine Designation with the SFDA marks a historic milestone for both Quoin and the Netherton Syndrome community. If granted, QRX003 could be available for sale and reimbursement in Saudi Arabia in the second half of this year, potentially becoming the first approved treatment globally for this devastating disease.”

Quoin is committed to working closely with its commercial partners to expedite the availability of QRX003 for patients in Saudi Arabia if the designation is granted.

Ongoing Clinical Trials for QRX003

The QRX003 lotion (4%) is currently under evaluation in two pivotal clinical trials focused on patients with Netherton Syndrome. Enrollment in these studies is expected to conclude in the first half of 2026, with top-line data anticipated in the latter half of the same year.

Pending successful clinical outcomes, Quoin plans to file a New Drug Application (NDA) for QRX003 in the United States and other regions in late 2026 or early 2027.

About Quoin Pharmaceuticals Ltd.

Quoin Pharmaceuticals Ltd. is dedicated to developing and commercializing innovative treatments for rare and orphan diseases. The company aims to address critical unmet medical needs of patients and their families, focusing on several conditions, including Netherton Syndrome, Peeling Skin Syndrome, and Scleroderma, among others.

For additional details, please visit www.quoinpharma.com or follow us on LinkedIn for updates.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by terms like “expect,” “anticipate,” “believe,” and similar expressions. Actual results may differ materially due to various risks and uncertainties, including the company's ability to meet regulatory requirements and successfully complete clinical trials.

Please refer to Quoin's Annual Report on Form 10-K for further details about factors that could affect these statements.

Contact Information

Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
Email: mmyers@quoinpharma.com

Investor Contact:
PCG Advisory
Jeff Ramson
Email: jramson@pcgadvisory.com
Phone: (646) 863-6341

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