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Quoin Pharmaceuticals Receives U.S. Notice of Allowance for Patent Covering Combination Treatment for Netherton Syndrome

(Positive)
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Quoin Pharmaceuticals (NASDAQ: QNRX) received a USPTO Notice of Allowance for patent application 18/428,570 covering a combination treatment for Netherton Syndrome. The allowed claims support the intellectual property and long-term commercialization strategy for QRX003 (QYLEKI), an investigational topical therapy with multiple regulatory designations.

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Positive

  • USPTO Notice of Allowance for Netherton Syndrome combination-treatment patent in the United States
  • Claims cover use of dipalmitoyl hydroxyproline plus an anti-inflammatory agent for Netherton Syndrome
  • Patent claims include patients with SPINK5 mutations and specific skin lesion locations
  • New patent expected to strengthen QRX003 intellectual property and commercialization strategy
  • QRX003 holds Orphan Drug, Rare Pediatric Disease, and Fast Track designations in the United States
  • QRX003 has Orphan Drug Designation in the European Union and Japan

Negative

  • Patent is not yet granted and is contingent on payment of the issue fee
  • QRX003 remains an investigational product with no current regulatory approvals

News Market Reaction – QNRX

+6.37%
2 alerts
+6.37% Session close to close
+2.9% Peak Tracked
-4.6% Trough Tracked
$9.98M Market Cap
0.1x Rel. Volume

In the Jun 30 session, QNRX gained 6.37%, reflecting a notable positive market reaction. Argus tracked a peak move of +2.9% during that session. Argus tracked a trough of -4.6% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +6.4% in the session following this news. A strong positive reaction aligns with rec...
Analysis

The stock moved +6.4% in the session following this news. A strong positive reaction aligns with recent IP and regulatory momentum, including the new U.S. patent allowance backing QRX003. However, sizeable registered ADS resale capacity and prior financing-related dilution could temper follow-through if warrant exercises or resales accelerate.

Key Figures

U.S. patent application: No. 18/428,570
1 metrics
U.S. patent application No. 18/428,570 USPTO Notice of Allowance for combination Netherton Syndrome treatment

Historical Context

5 past events · Latest: Jun 23 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jun 23 Brand name approval Positive -26.3% FDA conditional approval of QYLEKI as proposed brand name for QRX003.
Jun 18 Japanese subsidiary setup Positive +0.4% Completion of Japanese subsidiary to support potential QRX003 commercialization.
Jun 16 Compassionate use update Positive -4.1% Positive pediatric compassionate use data for QRX003 with no adverse events reported.
Jun 04 Japan orphan status Positive -3.2% Japan MHLW grants Orphan Drug Designation for QRX003 in Netherton Syndrome.
Jun 02 New IND submission Positive -4.4% IND filed for QRX003 in Peeling Skin Syndrome, adding a second indication.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive clinical and regulatory updates have often been followed by negative price reactions, indicating a tendency to diverge from supportive news.

Key Terms

notice of allowance, orphan drug designation, rare pediatric disease, fast track, +2 more
6 terms
notice of allowance regulatory
"the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance"
A notice of allowance is an official confirmation from a patent office that a patent application has met all necessary requirements and is approved for granting. It signals that the invention is likely to receive legal protection soon, which can be important for investors considering the value and exclusivity of a new product or technology. Think of it as a green light indicating that the invention is on track to become legally protected.
orphan drug designation regulatory
"holds Orphan Drug, Rare Pediatric Disease, and Fast Track designations in the United States"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
rare pediatric disease medical
"holds Orphan Drug, Rare Pediatric Disease, and Fast Track designations in the United States"
A rare pediatric disease is a serious medical condition that primarily affects children and occurs so infrequently that only a small number of patients exist. Investors care because treatments for such conditions often get special regulatory incentives—think of government fast lanes and rewards for developers—making smaller markets potentially profitable due to pricing power, shorter development timelines, and reduced competition, much like a niche product that receives government-backed advantages.
fast track regulatory
"holds Orphan Drug, Rare Pediatric Disease, and Fast Track designations in the United States"
A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.
serine protease inhibitor medical
"using a topical serine protease inhibitor, dipalmitoyl hydroxyproline, together with an anti-inflammatory agent"
A serine protease inhibitor is a drug or molecule that blocks a type of enzyme—called a serine protease—that cuts other proteins as part of normal body processes like blood clotting, digestion, immune response or viral replication. Investors care because these inhibitors can be developed into medicines that alter disease pathways; their success affects a company’s clinical progress, regulatory risk and potential market value much like a key that can lock an important biological ‘scissor’ from doing damage or causing disease.
spink5 medical
"patients carrying SPINK5 mutations, the genetic basis of Netherton Syndrome"
SPINK5 is a human gene that makes a protein acting like a brake on enzymes that break down skin proteins, helping keep the skin barrier intact. When this brake fails, it can lead to serious skin disorders, so drugs, tests, or devices aimed at restoring or measuring SPINK5 function can become commercial opportunities or regulatory risks; investors watch related clinical results, patents and approvals as potential value drivers.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Allowed Claims Cover a Method of Treating Netherton Syndrome with a Topical Serine Protease Inhibitor and an Anti-Inflammatory Agent, Including in Patients with SPINK5 Mutations

ASHBURN, Va., June 30, 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 United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 18/428,570, titled “Combination Treatment for Netherton Syndrome.”

The patent supports Quoin’s intellectual property strategy for QRX003, its investigational treatment for Netherton Syndrome, a rare genetic skin disease for which there are currently no approved treatments.

Key Facts

  • The USPTO has issued a Notice of Allowance for U.S. Patent Application No. 18/428,570, titled “Combination Treatment for Netherton Syndrome.”
  • The allowed claims cover a method of treating Netherton Syndrome using a topical serine protease inhibitor, dipalmitoyl hydroxyproline, together with an anti-inflammatory agent.
  • The claims include treatment of patients carrying SPINK5 mutations, the genetic basis of Netherton Syndrome.
  • The patent will be granted following payment of the issue fee.
  • QRX003 (QYLEKI™), Quoin’s investigational topical treatment for Netherton Syndrome, holds Orphan Drug, Rare Pediatric Disease, and Fast Track designations in the United States and Orphan Drug Designation in the European Union and Japan.
  • If approved, QRX003 has the potential to become the first approved treatment for Netherton Syndrome.

Patent Coverage

The allowed claims cover a method of treating Netherton Syndrome by administering a topical serine protease inhibitor, dipalmitoyl hydroxyproline, together with an anti-inflammatory agent. The claims include treatment of patients who carry mutations in the SPINK5 gene, the genetic basis of the disease, and cover application to skin lesions on the arms and lower legs. The allowed claims add to Quoin’s intellectual property position around its topical treatment approach for Netherton Syndrome and support the Company’s long-term commercialization strategy for QRX003.

The Notice of Allowance indicates that the application has completed substantive examination and is expected to proceed to issuance following payment of the required fees. Once granted, the patent will add to the Company’s intellectual property position in the United States covering its Netherton Syndrome program.

“The allowance of this patent is an important step in protecting the innovation behind our Netherton Syndrome program as we advance toward what could become the first approved treatment for this devastating disease,” said Dr. Michael Myers, Co-Founder and Chief Executive Officer of Quoin Pharmaceuticals. “Securing intellectual property protection in the United States reinforces the long-term value of the program as we continue to build the clinical, regulatory, and commercial foundations for QRX003.”

About Netherton Syndrome

Netherton Syndrome is a rare, serious genetic skin disease caused by mutations in the SPINK5 gene. The condition is characterized by impaired skin barrier function, persistent inflammation, and increased serine protease activity in the skin. There are currently no approved therapies in the United States indicated specifically for Netherton Syndrome.

About QRX003

QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug Designation in the European Union and Japan. The U.S. brand name QYLEKI™ has been accepted by the FDA. QRX003 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.

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.

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. This press release contains forward-looking statements. 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: Quoin’s strategy to directly commercialize QRX003 for the treatment of Netherton Syndrome, if approved; engaging directly with Japanese regulators, clinicians, and patient advocacy organizations as Quoin builds the commercial infrastructure to support a potential launch; self-commercializing QRX003 and the Company’s other pipeline products in Japan, the United States and Western Europe; facilitating almost global availability of the product if approved; continuing to build the commercial infrastructure in advance of a potential approval; initiating Quoin’s pivotal Phase 3 study in the second half of 2026, with a potential NDA filing in 2027; QRX003 having the potential to become the first approved treatment for Netherton Syndrome; working closely with leading Japanese clinicians to refine the clinical and regulatory pathway for approval of QRX003 for the treatment of Netherton Syndrome; 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, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex, 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 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


FAQ

What did Quoin Pharmaceuticals (NASDAQ: QNRX) announce about its Netherton Syndrome patent on June 30, 2026?

Quoin announced a USPTO Notice of Allowance for its Netherton Syndrome combination-treatment patent. According to Quoin, the allowed claims cover a topical serine protease inhibitor with an anti-inflammatory agent, supporting the company’s intellectual property and long-term commercialization strategy for QRX003.

What does the new Netherton Syndrome patent cover for Quoin’s QRX003 (QNRX)?

The allowed patent claims cover treating Netherton Syndrome with dipalmitoyl hydroxyproline plus an anti-inflammatory agent. According to Quoin, coverage includes patients with SPINK5 mutations and application to skin lesions on the arms and lower legs, strengthening U.S. protection for its Netherton program.

How could the USPTO Notice of Allowance impact QRX003’s commercialization prospects for Quoin (QNRX)?

The Notice of Allowance is expected to enhance QRX003’s intellectual property position in the United States. According to Quoin, once issued, the patent will support long-term commercialization plans for its Netherton Syndrome program as clinical, regulatory, and commercial foundations are developed.

Could Quoin’s QRX003 become the first approved treatment for Netherton Syndrome?

QRX003 has the potential to become the first approved treatment for Netherton Syndrome. According to Quoin, QRX003 is an investigational topical therapy for a disease with no current approved treatments, and the company is advancing clinical, regulatory, and commercial preparations around the program.

What regulatory designations does Quoin’s QRX003 hold in the United States, EU, and Japan?

QRX003 holds multiple special regulatory designations in major markets. According to Quoin, QRX003 has Orphan Drug, Rare Pediatric Disease, and Fast Track designations in the United States, plus Orphan Drug Designation in both the European Union and Japan for Netherton Syndrome.

When is Quoin’s new Netherton Syndrome patent expected to be granted and what remains outstanding?

The patent is expected to be granted after payment of the required issue fee. According to Quoin, the Notice of Allowance indicates substantive examination is complete and the application should proceed to issuance once fees are paid, adding to U.S. protection for the program.

What is the significance of SPINK5 mutation coverage in Quoin’s new Netherton Syndrome patent?

The patent explicitly includes treatment of patients with SPINK5 mutations, the genetic basis of Netherton Syndrome. According to Quoin, this genetic coverage helps protect its specific topical treatment approach and may be important for addressing the underlying biology of the rare skin disease.