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

Rhea-AI Summary

Quoin Pharmaceuticals (NASDAQ: QNRX) filed for Breakthrough Medicine Designation with the Saudi Food and Drug Authority for QRX003, its late‑stage topical candidate for Netherton Syndrome. If granted, the designation could enable accelerated review and potential sale and reimbursement in Saudi Arabia as early as 2H 2026. QRX003 holds U.S. Orphan and Pediatric Rare Disease designations and an EU Orphan designation. QRX003 lotion (4%) is in two pivotal whole‑body trials with enrollment expected to finish in 1H 2026 and top‑line data anticipated in 2H 2026. Quoin has a regional distribution partnership with Genpharm for Saudi Arabia and MENA.

Positive

• Filed for SFDA Breakthrough Medicine Designation for QRX003
• Holds U.S. Orphan and Pediatric Rare Disease designations and an EU Orphan designation
• Two late‑stage pivotal whole‑body trials with enrollment finishing 1H 2026
• Regional distribution partnership with Genpharm for Saudi Arabia and MENA

Negative

• SFDA Breakthrough designation is not yet granted, outcome uncertain
• Potential Saudi approval/reimbursement by 2H 2026 is conditional on designation and review
• U.S./other NDA planned for late 2026/early 2027 only subject to successful clinical outcomes

News Market Reaction

+1.75%

1 alert

+1.75% News Effect

+$138K Valuation Impact

$8M Market Cap

1.2x Rel. Volume

On the day this news was published, QNRX gained 1.75%, reflecting a mild positive market reaction. This price movement added approximately $138K to the company's valuation, bringing the market cap to $8M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Potential Saudi approval timing: 2H 2026 QRX003 lotion strength: 4% Pivotal trials count: 2 trials +3 more

6 metrics

Potential Saudi approval timing 2H 2026 Earliest potential sale and reimbursement for QRX003 in Saudi Arabia if designation granted

QRX003 lotion strength 4% Concentration of QRX003 lotion being evaluated in pivotal Netherton Syndrome trials

Pivotal trials count 2 trials Two late-stage whole-body pivotal clinical trials in Netherton Syndrome

Pivotal enrollment completion 1H 2026 Enrollment in both QRX003 pivotal studies expected to complete in first half of 2026

Top-line data timing 2H 2026 Top-line data from pivotal QRX003 studies anticipated in second half of 2026

Planned NDA timing Late 2026/early 2027 Target window for NDA submissions, subject to successful clinical outcomes

Market Reality Check

Price: $9.97 Vol: Volume 45,464 is 1.32x th...

normal vol

$9.97 Last Close

Volume Volume 45,464 is 1.32x the 20-day average of 34,435, indicating elevated trading activity before this news. normal

Technical Price $10.27 is trading above the 200-day MA at $9.86, but remains 75.43% below the 52-week high and 104.99% above the 52-week low.

Peers on Argus

Pre-news action appears stock-specific. Momentum scanner flagged only JAGX movin...

1 Down

Pre-news action appears stock-specific. Momentum scanner flagged only JAGX moving, down 30.38%. Other biotech peers showed mixed single-day moves (e.g., AZTR +1.55%, XRTX -0.88%, CNSP +, XBIO +6.87%), with no broad, aligned sector direction.

Historical Context

5 past events · Latest: Nov 11 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 11	Pipeline advancement	Positive	+41.4%	Announced achieving target rapamycin loadings and plans for 2026 clinical trials.
Nov 06	Earnings & financing	Positive	-11.2%	Q3 update with major private placement, stronger cash and QRX003 progress.
Oct 30	Earnings preview	Neutral	-7.2%	Scheduled date announcement for Q3 2025 results and corporate update.
Oct 28	Clinical data update	Positive	-1.7%	Reported positive 9‑month pediatric Netherton data and added three patients.
Oct 21	FDA orphan status	Positive	-1.2%	Announced U.S. FDA Orphan Drug Designation for QRX003 in Netherton Syndrome.

Pattern Detected

Positive clinical and financing milestones have often seen muted or negative next-day moves, with only the topical rapamycin technology update showing a strong positive alignment.

Recent Company History

Over the last few months, Quoin reported several key milestones for QRX003 and its broader pipeline. These included FDA and EMA orphan designations for Netherton Syndrome, positive pediatric whole-body data, and a large private placement aimed at funding programs into 2027. A technical breakthrough in topical rapamycin loadings on Nov 11, 2025 coincided with a strong 41.4% move. Today’s Saudi Breakthrough Medicine Designation filing continues this regulatory and clinical momentum in Netherton Syndrome.

Regulatory & Risk Context

Active S-3 Shelf · $88.7 million

Shelf Active

Active S-3 Shelf Registration 2025-11-07

$88.7 million registered capacity

An effective Form S-3 filed on Nov 7, 2025 registers the resale of up to 10,045,455 ADSs, roughly 1,193% of the 838,976 ADSs then outstanding. Quoin will not receive proceeds from resales but could receive up to $88.7 million if accompanying warrants are exercised for cash, while the registered ADSs could create substantial dilution pressure as they enter the market.

Market Pulse Summary

This announcement advances Quoin’s Netherton Syndrome strategy by seeking Saudi Breakthrough Medicin...

Analysis

This announcement advances Quoin’s Netherton Syndrome strategy by seeking Saudi Breakthrough Medicine Designation for QRX003, complementing existing FDA and EMA orphan recognitions. Enrollment and data milestones around 2026 and the planned NDA window of late 2026/early 2027 are key future catalysts. At the same time, the company maintains an S-3 for resale of up to 10,045,455 ADSs, so investors may watch both trial execution and how registered shares enter the market.

Key Terms

breakthrough medicine designation, netherton syndrome, orphan drug, pediatric rare disease designation, +1 more

5 terms

breakthrough medicine designation regulatory

"it has filed an application for Breakthrough Medicine Designation with the Saudi"

A breakthrough medicine designation is a formal status granted by a drug regulator that signals a new treatment shows substantial promise for a serious condition and qualifies for faster, more intensive review. For investors it matters because the designation can shorten development time, reduce some regulatory hurdles and raise the likelihood of eventual approval, similar to giving a promising product a VIP fast‑track through the approval process which can boost a company’s value and investor interest.

netherton syndrome medical

"for QRX003, its lead investigational, late-stage topical product candidate for the treatment of Netherton Syndrome."

A rare inherited skin and immune disorder that causes fragile, scaly, inflamed skin, frequent infections, and fragile or unusual hair, like a house with faulty waterproofing that lets problems in. For investors, it matters because the small patient population, severe unmet medical need, and predictable biological cause can make treatments eligible for special regulatory incentives, faster development paths, and premium pricing if a safe, effective therapy is approved.

orphan drug regulatory

"QRX003 has received Orphan Drug and Pediatric Rare Disease Designations from the U.S."

A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.

pediatric rare disease designation regulatory

"has received Orphan Drug and Pediatric Rare Disease Designations from the U.S."

A pediatric rare disease designation is a formal regulatory status given to a drug or therapy aimed at a serious, uncommon illness that primarily affects children. It matters to investors because the designation often brings financial and timing advantages—such as development funding, tax breaks, faster review, or market protections—similar to getting a VIP pass that lowers costs and increases the chance of reaching patients and generating returns.

new drug application (nda) regulatory

"Quoin plans to submit a New Drug Application (NDA) in the United States and other"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

AI-generated analysis. Not financial advice.

If granted, QRX003 could be approved for sale and reimbursement in Saudi Arabia as a treatment for Netherton Syndrome in 2H 2026

QRX003 could become the first ever approved treatment for Netherton Syndrome

ASHBURN, Va., Jan. 20, 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 it has filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003, its lead investigational, late-stage topical product candidate for the treatment of Netherton Syndrome.

The SFDA’s Breakthrough Medicine Designation program is designed to expedite the development, review, and potential availability of medicines that address serious or life-threatening conditions with high unmet medical need and which meet SFDA eligibility requirements, which include:

• Targets serious debilitating or life-threatening conditions with unmet medical need.
• The medicinal product is likely to offer major advantages over methods currently used.
• The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance.
• The product is not registered with any regulatory authority at the time of submission of the designation request.

Quoin believes that QRX003 meets each of these eligibility requirements.

If granted, the designation will allow for accelerated regulatory review and could enable earlier patient access in Saudi Arabia, potentially as early as 2H 2026.

QRX003 has received Orphan Drug and Pediatric Rare Disease Designations from the U.S. Food and Drug Administration and Orphan Drug Designation from the European Medicines Agency for the potential treatment of Netherton Syndrome. Quoin has an established distribution partnership with Genpharm for QRX003 for Saudi Arabia and other MENA countries.

“Filing for Breakthrough Medicine Designation with the SFDA marks a historic milestone for both Quoin and the Netherton Syndrome community,” said Dr. Michael Myers, Chief Executive Officer of Quoin Pharmaceuticals. “If granted, it is possible that QRX003 could be available for sale and reimbursement in Saudi Arabia in the second half of this year. This would make QRX003 the first ever approved treatment anywhere in the world for this devastating disease. We look forward to working with our commercial partner in the region to make QRX003 available to Netherton patients in Saudi Arabia as expeditiously as possible, if the designation is granted.”

QRX003 lotion (4%) is currently being evaluated in two late-stage whole-body pivotal clinical trials in patients with Netherton Syndrome. Enrollment in both studies is expected to be completed in the first half of 2026, with top-line data anticipated in the second half of 2026. Quoin plans to submit a New Drug Application (NDA) in the United States and other territories in late 2026/early 2027, subject to successful clinical outcomes.

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 comprises three products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma 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 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 approved for sale and reimbursement in Saudi Arabia as a treatment for Netherton Syndrome in 2H 2026, QRX003 becoming the first ever approved treatment for Netherton Syndrome, QRX003 meeting the eligibility requirements for the SFDA’s Breakthrough Medicine Designation program, working with Quoin’s commercial partner in the region to make QRX003 available to Netherton patients in Saudi Arabia as expeditiously as possible, if the designation is granted, completing enrollment for QRX003 lotion (4%) in two late-stage whole-body pivotal clinical trials in patients with Netherton Syndrome in the first half of 2026, with top-line data anticipated in the second half of 2026, plans to submit a NDA in the United States and other territories in late 2026/early 2027, subject to successful clinical outcomes, 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, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, 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 deliver a safe and effective treatment for Netherton Syndrome; 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; the Company experiencing unanticipated or higher than expected clinical trial costs; the Company’s ability to obtain the capital necessary to fund its activities; 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.

For further information, contact:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com

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

FAQ

What did Quoin Pharmaceuticals (QNRX) file with the SFDA on January 20, 2026?

Quoin filed for Breakthrough Medicine Designation with the SFDA for QRX003, its topical candidate for Netherton Syndrome.

Could QRX003 be available in Saudi Arabia in 2026 and under what condition?

If the SFDA grants Breakthrough designation and review proceeds, QRX003 could be available for sale and reimbursement in 2H 2026.

What clinical milestones does Quoin expect for QRX003 in 2026?

Enrollment in two pivotal whole‑body trials is expected to complete in 1H 2026 with top‑line data anticipated in 2H 2026.

Has QRX003 received any regulatory designations already?

Yes. QRX003 has received Orphan Drug and Pediatric Rare Disease designations from the U.S. FDA and an Orphan designation from the European Medicines Agency.

What are Quoin’s plans for filing an NDA for QRX003?

Quoin plans to submit a New Drug Application in the United States and other territories in late 2026/early 2027, subject to successful clinical outcomes.