Quoin Pharmaceuticals Provides Product Portfolio Update
Quoin Pharmaceuticals (NASDAQ: QNRX) provided an update on its rare disease product portfolio, highlighting progress in multiple clinical programs. The company's lead product, QRX003, is advancing in two pivotal registrational studies for Netherton Syndrome across multiple regions, with full recruitment targeted for early-mid Q1 2026.
The company reported positive initial data from its Peeling Skin Syndrome (PSS) study, showing significant improvements across key endpoints. Quoin's topical rapamycin program for various rare skin conditions continues to progress, with clinical testing expected to begin in H1 2026.
To optimize resources, Quoin has discontinued development of QRX007 for Netherton Syndrome and QRX004 for Epidermolysis Bullosa, focusing instead on more promising opportunities.
Quoin Pharmaceuticals (NASDAQ: QNRX) ha fornito un aggiornamento sul suo portafoglio di prodotti per malattie rare, evidenziando i progressi in diversi programmi clinici. Il prodotto principale dell'azienda, QRX003, sta avanzando in due studi registrativi fondamentali per la Sindrome di Netherton in più regioni, con un reclutamento completo previsto per l'inizio-metà del primo trimestre 2026.
L'azienda ha riportato dati iniziali positivi dal suo studio sulla Sindrome della Pelle Desquamante (PSS), mostrando miglioramenti significativi nei principali parametri di valutazione. Il programma topico a base di rapamicina di Quoin per varie rare condizioni cutanee continua a progredire, con l'inizio dei test clinici previsto per la prima metà del 2026.
Per ottimizzare le risorse, Quoin ha interrotto lo sviluppo di QRX007 per la Sindrome di Netherton e di QRX004 per l'Epidermolisi Bollosa, concentrandosi invece su opportunità più promettenti.
Quoin Pharmaceuticals (NASDAQ: QNRX) proporcionó una actualización sobre su cartera de productos para enfermedades raras, destacando avances en múltiples programas clínicos. El producto principal de la compañía, QRX003, avanza en dos estudios registrales clave para el Síndrome de Netherton en varias regiones, con la finalización del reclutamiento prevista para principios-mediados del primer trimestre de 2026.
La compañía reportó datos iniciales positivos de su estudio sobre el Síndrome de Descamación de la Piel (PSS), mostrando mejoras significativas en los principales puntos finales. El programa tópico de rapamicina de Quoin para diversas enfermedades cutáneas raras continúa progresando, con pruebas clínicas previstas para iniciar en la primera mitad de 2026.
Para optimizar recursos, Quoin ha descontinuado el desarrollo de QRX007 para el Síndrome de Netherton y QRX004 para Epidermólisis Bullosa, enfocándose en cambio en oportunidades más prometedoras.
Quoin Pharmaceuticals (NASDAQ: QNRX)는 희귀질환 제품 포트폴리오에 대한 최신 정보를 제공하며 여러 임상 프로그램에서의 진전을 강조했습니다. 회사의 주력 제품인 QRX003은 여러 지역에서 네스턴 증후군에 대한 두 건의 주요 등록 임상시험을 진행 중이며, 2026년 1분기 초중반까지 완전한 환자 모집을 목표로 하고 있습니다.
회사는 박리성 피부증후군(PSS) 연구에서 긍정적인 초기 데이터를 보고했으며, 주요 평가 지표 전반에 걸쳐 유의미한 개선을 보였습니다. 다양한 희귀 피부 질환을 위한 Quoin의 국소 라파마이신 프로그램도 순조롭게 진행 중이며, 2026년 상반기에 임상 시험이 시작될 예정입니다.
자원 최적화를 위해 Quoin은 네스턴 증후군용 QRX007과 표피수포증용 QRX004의 개발을 중단하고, 보다 유망한 기회에 집중하기로 했습니다.
Quoin Pharmaceuticals (NASDAQ: QNRX) a fourni une mise à jour sur son portefeuille de produits pour les maladies rares, mettant en avant les progrès réalisés dans plusieurs programmes cliniques. Le produit phare de la société, QRX003, progresse dans deux études d'enregistrement majeures pour le syndrome de Netherton dans plusieurs régions, avec un recrutement complet prévu pour début à mi-T1 2026.
La société a rapporté des données initiales positives issues de son étude sur le syndrome de peau qui pèle (PSS), montrant des améliorations significatives sur les critères principaux. Le programme topique à base de rapamycine de Quoin pour diverses maladies rares de la peau continue d'avancer, avec un début des essais cliniques attendu au premier semestre 2026.
Pour optimiser ses ressources, Quoin a arrêté le développement de QRX007 pour le syndrome de Netherton et de QRX004 pour l'épidermolyse bulleuse, se concentrant plutôt sur des opportunités plus prometteuses.
Quoin Pharmaceuticals (NASDAQ: QNRX) gab ein Update zu seinem Produktportfolio für seltene Krankheiten und hob Fortschritte in mehreren klinischen Programmen hervor. Das führende Produkt des Unternehmens, QRX003, befindet sich in zwei entscheidenden Zulassungsstudien für das Netherton-Syndrom in mehreren Regionen, mit vollständiger Rekrutierung, die für Anfang bis Mitte Q1 2026 geplant ist.
Das Unternehmen berichtete über positive erste Daten aus seiner Studie zum Peeling Skin Syndrom (PSS), die signifikante Verbesserungen bei wichtigen Endpunkten zeigte. Quoins topisches Rapamycin-Programm für verschiedene seltene Hauterkrankungen schreitet weiter voran, klinische Tests sollen im ersten Halbjahr 2026 beginnen.
Zur Optimierung der Ressourcen hat Quoin die Entwicklung von QRX007 für das Netherton-Syndrom und QRX004 für Epidermolysis bullosa eingestellt und konzentriert sich stattdessen auf vielversprechendere Möglichkeiten.
- QRX003 on track to potentially become first approved treatment for Netherton Syndrome with NDA filing targeted for 2H 2026
- Positive initial PSS study data showing two-grade improvement in Global Assessment and substantial CDLQI improvement
- Established nine commercial partnerships covering 61 countries for QRX003 global distribution
- Advancing topical rapamycin program with two proprietary delivery platforms
- Discontinued development of QRX007 for Netherton Syndrome
- Halted development of QRX004 for Epidermolysis Bullosa
Insights
Quoin's lead drug QRX003 advances in pivotal trials, positive preliminary data in secondary indication, while company narrows focus on highest-potential programs.
Quoin's update reveals significant progress in its rare disease pipeline, particularly its lead asset QRX003 for Netherton Syndrome (NS), which is advancing through two separate registrational studies. The dual-pathway approach—testing QRX003 as both monotherapy and in combination with systemic therapy—represents a strategically sound clinical development strategy that maximizes chances of regulatory success. The targeted enrollment of 12-16 subjects per study aligns with expectations for ultra-rare disease trials, with full recruitment projected by Q1 2026.
The preliminary positive data from the Peeling Skin Syndrome (PSS) study represents a potentially significant expansion opportunity. The observed two-grade improvement in Investigator's Global Assessment (from severe to mild) and substantial reductions in both the Modified Ichthyosis Area Severity Index (from 36 to 12) and Children's Dermatology Life Quality Index (from 19 to 11) suggest meaningful clinical benefit in a condition with no approved treatments.
Quoin's pipeline rationalization—discontinuing QRX007 for NS and QRX004 for Epidermolysis Bullosa—reflects appropriate resource allocation toward programs with highest near-term potential. The company's transition to pre-commercialization activities for QRX003, targeting an NDA filing in 2H 2026, indicates confidence in their clinical data and regulatory pathway.
The topical rapamycin program leveraging two proprietary delivery technologies (dissolvable microneedle technology and a licensed platform) demonstrates Quoin's commitment to platform diversification while maintaining focus on rare dermatological conditions. The anticipated clinical testing in 1H 2026 suggests steady pipeline progression behind the lead program.
Quoin advances late-stage orphan drug candidates while streamlining portfolio; NDA filing timeline established for lead program.
Quoin's portfolio update reveals a company effectively balancing late-stage asset progression with prudent pipeline management. QRX003, positioned to potentially become the first-ever approved treatment for Netherton Syndrome, is progressing through dual registrational trials with a clearly defined regulatory timeline. The targeted NDA filing in 2H 2026 provides investors with a concrete milestone that signals the company's transition from clinical-stage to commercial-ready operations.
The commercial strategy demonstrates foresight with nine partnership agreements already secured covering 61 countries, complementing Quoin's self-commercialization plans for major markets (US, Western Europe, Japan). This hybrid approach optimizes resource allocation while maximizing global market penetration for a rare disease therapy.
The promising preliminary PSS data represents a potential label expansion opportunity using the same product (QRX003), which could leverage existing manufacturing and clinical experience. This approach of expanding indications for lead assets typically offers improved R&D efficiency compared to developing entirely new compounds.
The strategic discontinuation of secondary Netherton Syndrome program (QRX007) and the Epidermolysis Bullosa program (QRX004) indicates disciplined capital allocation, focusing resources on programs with highest probability of technical and commercial success. This portfolio refinement should extend runway and sharpen organizational focus at a critical juncture approaching potential commercialization.
The topical rapamycin program utilizing two distinct delivery technologies provides potential pipeline diversification with shared technical and commercial infrastructure. This balanced approach of advancing late-stage assets while maintaining selective early-stage programs represents sound portfolio management for a specialty pharmaceutical company targeting orphan indications.
Lead Product, QRX003, Being Tested in Two Active Registrational Clinical Studies for Netherton Syndrome Across the U.S., Europe, and the Middle East.
QRX003 Peeling Skin Syndrome Clinical Program Continues Following Positive Initial Data
Topical Rapamycin Development Programs Advancing Using Two Proprietary Delivery Technologies
ASHBURN, Va., July 29, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical stage specialty pharmaceutical company focused on rare and orphan diseases, today provided an updated overview of its development product portfolio.
The company’s lead product, QRX003 for Netherton Syndrome (NS), continues to advance in two pivotal registrational clinical studies. The studies are being conducted at clinical sites in the US, Europe and the Middle East. In each study QRX003 is applied twice-daily to greater than
QRX003 remains on track to potentially become the first approved treatment for NS and Quoin is targeting filing an NDA for regulatory approval in 2H 2026. Quoin plans to self-commercialize QRX003 in the US, Western Europe and Japan and has signed nine commercial partnerships covering 61 additional countries to support global access of the product once approved.
On May 14, 2025, Quoin announced positive initial data from its investigator led Peeling Skin Syndrome (PSS) clinical study which is being conducted in a single patient in New Zealand. The company reported positive data across key endpoints including a clinically meaningful two-grade improvement in the Investigator’s Global assessment from 4 (severe) to 2 (mild), a substantial improvement in the Modified Ichthyosis Area Severity Index from 36 (scale 0-48) at baseline to 12 after 12 weeks of treatment with QRX003. In addition, in the validated Children’s Dermatology Life Quality Index (CDLQI) endpoint, a substantial improvement from 19 (scale 0-30) at baseline to 11 was observed, Quoin intends to further expand this study and recruit an additional 4 to 6 subjects. There are currently no approved treatments or cures for PSS and the data released by Quoin represent the first known clinical findings for this disease.
Quoin’s topical rapamycin program, which is being developed under a research agreement with The School of Pharmacy at University College Cork in Ireland, continues to progress. The program targets rare and orphan skin diseases including microcystic lymphatic malformations, venous malformations, and angiofibromas. Two proprietary delivery platforms are being evaluated including UCC’s dissolvable microneedle technology and a Quoin in-licensed technology. Clinical testing of one or more selected formulations is anticipated to be initiated in the first half of 2026.
In light of the expected near-term completion of the QRX003 clinical program for NS, Quoin has discontinued the development of QRX007 for NS. QRX007 was being developed through Quoin’s research agreement with The Queensland University of Technology (QUT) in Australia. Quoin’s other research agreement with QUT for QRX008 remains in force. Finally, given the broad- based nature of its development portfolio, Quoin has decided to not advance the development of QRX004 as a potential treatment for Epidermolysis Bullosa (EB).
Dr. Michael Myers, Chief Executive Officer of Quoin commented, “We are very pleased to provide this very positive update on the status of our development product portfolio. This is a very exciting time for Quoin as we look to close out the QRX003 clinical program in Netherton Syndrome and release topline data from both studies early next year. We are actively transitioning Quoin into pre-commercialization mode in anticipation of the potential approval and launch of QRX003 in the next 18 to 24 months. We are also encouraged by the strong progress in our PSS and topical rapamycin programs which have helped inform our decision to focus our resources on these high potential opportunities and discontinue our second NS and EB programs. We look forward to providing additional updates on each of these products in due course.”
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 four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, microcystic lymphatic malformations, venous malformations, angiofibromas 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 a description 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,” “plan,” “anticipate,” “believe,” 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 continuing to advance QRX003 for NS in two pivotal registrational clinical studies, recruiting between 12 to 16 subjects for each study, targeting full recruitment for early to mid Q1 2026, QRX003 remaining on track to potentially become the first approved treatment for NS, Quoin targeting filing an NDA for regulatory approval in [2H 2026], plans to self-commercialize QRX003 in the US, Western Europe and Japan, supporting global access of the product once approved through nine commercial partnerships covering 61 additional countries, further expanding Quoin’s PSS clinical study and recruiting an additional 4 to 6 subjects, advancing Quoin’s topical rapamycin program, clinical testing of one or more selected formulations is anticipated in the first half of 2026, look to close the QRX003 clinical program in NS this year and release topline data from both studies in early next year, transitioning Quoin into pre-commercialization mode in anticipation of potential approval and launch in the next 18 to 24 months, providing additional updates on each of the products in due course 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, Scleroderma, microcystic lymphatic malformations, venous malformations, angiofibromas 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, 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.
Dr. Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com
Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341
FAQ
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