ASHBURN, Va. — September 8, 2026
Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation to QRX003 for Peeling Skin Syndrome (PSS), marking the second RPD designation awarded to the company’s lead development program. The FDA had previously granted RPD designation to QRX003 for Netherton Syndrome, expanding the regulatory recognition surrounding the asset’s potential in rare pediatric dermatological diseases. The new designation strengthens Quoin’s development strategy for QRX003 as the company prepares to advance the program into a Phase 2 clinical study expected to begin in the second half of 2026. The planned study is expected to enroll up to 12 pediatric and adult patients with Peeling Skin Syndrome across clinical sites in the United States and Europe, providing an important step toward generating clinical evidence for a condition with no currently approved treatment.
QRX003 Could Support Priority Review Voucher Strategy
The RPD designation could provide Quoin with a potentially significant regulatory and financial opportunity through the Priority Review Voucher (PRV) program. If an NDA for QRX003 in Peeling Skin Syndrome is ultimately approved, Quoin may qualify to receive a freely tradable PRV, which could be redeemed for priority FDA review of another eligible marketing application or transferred or sold to another party. Because QRX003 already holds an RPD designation for Netherton Syndrome, the company believes the program could potentially qualify for two PRVs if regulatory requirements are met and the respective indications receive approval. Quoin CEO Dr. Michael Myers said the potential value of the two vouchers could represent more than $300 million in aggregate non-dilutive cash value, based on current PRV trading values cited by the company. While the potential voucher value remains dependent on future regulatory outcomes and market conditions, the designation adds an important strategic component to Quoin’s broader development and capital planning for QRX003.
Phase 2 Study Targets Underserved Peeling Skin Patients
Quoin expects to initiate the first formal U.S. clinical study of Peeling Skin Syndrome under an open IND before the end of 2026, subject to the company’s development plans. The planned Phase 2 study is designed to include both pediatric and adult patients and is expected to enroll up to 12 participants across the United States and Europe. Peeling Skin Syndrome is a rare autosomal recessive genodermatosis associated with loss-of-function variants in the corneodesmosin gene, or CDSN, leading to excessive shedding of superficial epidermal layers. Patients can experience substantial disease burden, including severe pain and chronic pruritus, while currently having no approved treatment specifically addressing the underlying condition. For Quoin, moving QRX003 into Phase 2 represents a key clinical development milestone and provides an opportunity to establish a formal clinical evidence base for a highly underserved patient population while advancing the company’s broader rare-disease strategy.
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Quoin Expands QRX003 Rare-Disease Development Strategy
The second RPD designation reinforces Quoin’s strategy of developing QRX003 as a platform-oriented asset across multiple rare and orphan dermatological indications. The company’s late clinical-stage pipeline includes QRX003 and QRX009, with programs spanning conditions such as Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex. QRX003 is therefore being positioned as more than a single-indication development program, with regulatory progress in PSS adding to its existing Netherton Syndrome pathway. The planned Phase 2 study, combined with the FDA’s second RPD designation, provides Quoin with additional clinical and regulatory momentum as it seeks to advance treatments for rare diseases with limited therapeutic options. With QRX003 moving toward Phase 2 in PSS and carrying RPD designations in two indications, Quoin is strengthening both its clinical development pipeline and its potential long-term regulatory and commercial opportunities in rare dermatological diseases.
Source: Quoin Pharmaceuticals, ,press release
