ASHBURN, Va. — May 7, 2026 — Leads & Copy — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, provided an update on its first quarter 2026 progress and announced recent corporate achievements.
According to Dr. Michael Myers, Chief Executive Officer and Co-Founder of Quoin Pharmaceuticals, the first quarter of 2026 delivered meaningful regulatory progress on a number of fronts for QRX003 for Netherton Syndrome.
In the United States, the company was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The agency also indicated that a single Phase 3 study may be sufficient to support marketing approval, with expressed openness to an alternative study design for Phase 3 that would likely not include a traditional upfront vehicle or placebo control, following a constructive Type C meeting with the FDA.
Quoin submitted its Orphan Drug Designation application in Japan, following confirmation from MHLW that QRX003 qualifies for both ODD and Fast Track review. In Saudi Arabia, the company filed for Breakthrough Medicine Designation, which could expedite the path to patient access, if granted.
The company also remains on track to complete Phase 3 recruitment this year and potentially file for NDA approval in 2027.
Quoin has made substantial progress this year with its QRX009 topical rapamycin platform and are now in a position to initiate clinical testing in a number of indications later this year including investigator studies for Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex through engagement with KOLs and advocacy foundations. The company is also planning to submit an Investigational New Drug (IND) Application to the FDA for QRX009 for an additional indication by Q3 of this year.
On January 20, 2026, Quoin filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003. Quoin has an established distribution partnership with Genpharm for QRX003 in Saudi Arabia and other MENA countries.
On January 27, 2026, Quoin submitted an application to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking Orphan Drug Designation for QRX003 and MHLW confirmed that QRX003 qualifies for both Orphan Drug Designation and Fast Track review in Japan. The Company has also initiated the establishment of a Japanese subsidiary to facilitate self-commercialization of QRX003 in Japan, if approved.
On February 3, 2026, the U.S. Rare Pediatric Disease Priority Review Voucher (PRV) program was extended by Congress through September 30, 2029 as part of the Give Kids a Chance Reauthorization Act. QRX003 previously received Rare Pediatric Disease Designation from the FDA in June 2025. Upon approval of QRX003, Quoin would be eligible to receive a Priority Review Voucher, which if awarded may be used to obtain priority review for another product or sold or transferred.
On March 11, 2026, the U.S. FDA granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome.
On April 28, 2026, Quoin announced the planned initiation of an investigator-led clinical study in Pachyonychia Congenita led by Professor Edel O’Toole, Queen Mary University of London as well as additional investigator-led studies in Gorlin Syndrome and Tuberous Sclerosis Complex and is targeting to submit an IND to the FDA for QRX009 for an additional indication in Q3 of 2026.
QRX003 lotion (4%) continues to be evaluated in late-stage whole-body clinical trials for the treatment of Netherton Syndrome, with topline data anticipated in the second half of 2026. The ongoing pediatric investigator-led study has been expanded to six children actively being treated with QRX003 in Ireland, Austria, the Netherlands, and New Zealand, representing the largest pediatric cohort of this age group ever studied in Netherton Syndrome.
Quoin continues to advance its Peeling Skin Syndrome (PSS) program, with the ongoing investigator-led study being expanded to six subjects and plans to submit an IND to the FDA for PSS in Q2 of 2026.
Quoin had approximately $14 million in cash, cash equivalents and marketable securities as of March 31, 2026. The Company believes its current cash position will fund operations into 2027.
Net loss for the quarter ended March 31, 2026, was approximately $5 million compared to approximately $3.8 million for the quarter ended March 31, 2025.
Quoin Pharmaceuticals Ltd. is focused on developing and commercializing therapeutic products that treat rare and orphan diseases. 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, PC, GS, TSC, microcystic lymphatic malformations, venous malformations, angiofibromas and others.
Investors are encouraged to read the Company’s Quarterly Report on Form 10-Q when filed with the Securities and Exchange Commission, which will contain additional details about Quoin’s financial results as of and for the period ended March 31, 2026.
Source: Quoin Pharmaceuticals Ltd.
