Quoin Pharmaceuticals Ltd. (QNRX) reports news about a late clinical-stage specialty pharmaceutical company developing therapies for rare and orphan diseases. Updates center on QRX003 lotion for Netherton Syndrome and related rare skin disorders, including clinical-study progress and U.S. and European orphan, rare pediatric disease and fast track regulatory designations.
Company news also covers QRX009 topical rapamycin development programs, rare dermatologic and genetic disease research, quarterly financial results, private-placement financing and distribution or commercialization arrangements for potential international markets.
Quoin Pharmaceuticals (QNRX) announced publication of a peer-reviewed paper describing QRX003 and a pediatric compassionate-use case in Netherton Syndrome. Published online October 13, 2026, in Dermatology and Therapy, the paper describes once-daily, whole-body treatment added to the patient’s existing treatment plan. Skin severity improved from severe to clear and itch disappeared by eight months. Over 21 months, skin remained mostly clear, with occasional almost-clear assessments; no treatment-related adverse events were reported.
Separately, four of the first six participants completing 12 weeks in the ongoing Phase 2/3 study achieved its primary endpoint of at least a one-grade improvement in skin severity. Quoin expects recruitment of all 20 participants by year-end 2026 and topline data in Q2 2027. The case report describes one patient, with clinical trials continuing to evaluate safety and efficacy.
Quoin Pharmaceuticals (NASDAQ: QNRX) has received European Medicines Agency orphan drug designation for QRX003 to treat Peeling Skin Syndrome. The designation provides scientific advice on study protocols, fee reductions and access to EU grants. Marketing approval would confer 10 years of European market exclusivity against similar medicines for this condition.
Quoin expects to initiate a formal Peeling Skin Syndrome clinical trial before year-end 2026. QRX003 also holds US Pediatric Rare Disease and Fast Track designations for this condition. For Netherton Syndrome, it holds orphan drug designations in the US, Europe and Japan, plus US Pediatric Rare Disease and Fast Track designations, and is undergoing late-stage clinical trials.
Quoin Pharmaceuticals (NASDAQ: QNRX) announced acceptance of a peer-reviewed paper on investigational QRX003 for publication in Dermatology and Therapy.
The paper introduces the topical lotion’s mechanism in Netherton Syndrome and describes Professor Alan Irvine’s treatment of one pediatric patient under Quoin’s Compassionate Use Program. The case report describes fully healed skin, elimination of itching and resulting nightly sleep disturbances, and reduced need for previously required medications.
Separately, an August interim analysis of the ongoing Phase 2/3 study evaluated the first six participants completing 12 weeks of QRX003 4% lotion. Four of six (66.7%) achieved the primary endpoint: at least a 1-grade improvement on the Investigator Global Assessment, a clinician-rated assessment (p=0.0087 versus a pre-specified alpha of 0.0215).
Quoin Pharmaceuticals (QNRX) received FDA Fast Track Designation for its investigational topical lotion QRX003 to treat Peeling Skin Syndrome (PSS).
This is the first Fast Track Designation ever granted for a PSS therapy and the second indication for which QRX003 has Fast Track status, following Netherton Syndrome. The designation follows FDA clearance in July 2026 of the first Investigational New Drug application ever submitted for PSS, which Quoin filed on June 2, 2026. Quoin plans to start a Phase 2/3 study in 2H 2026 in the U.S. and Europe, enrolling up to 12 pediatric and adult patients treated twice daily over 48 weeks, with an interim review at 24 weeks. The IND was supported by an ongoing investigator-led pediatric study in a single subject showing skin improvements and better pruritus and quality-of-life measures with over 15 months of dosing and no reported adverse events. Quoin is targeting potential QRX003 approval for PSS in 2028.
Quoin Pharmaceuticals (QNRX) released a new NETHERTON NOW video episode featuring Aminah’s story, told by her adoptive mother, pediatric critical care physician Laura Wright-Sexton, MD. The video highlights Aminah’s early life-threatening complications from Netherton Syndrome, her adoption, and her subsequent developmental progress. It also underscores the uncertainty families face with this rare disease and the value of online patient communities. Quoin’s lead product QRX003 is being evaluated in a Phase 2/3 trial for Netherton Syndrome, and the company recently reported positive interim clinical data from this ongoing study. The video is available on YouTube.
Quoin Pharmaceuticals (QNRX) received U.S. FDA Rare Pediatric Disease (RPD) Designation for its lead candidate QRX003 to treat Peeling Skin Syndrome (PSS) as of September 8, 2026.
This is the second RPD designation for QRX003, following an earlier RPD designation in Netherton Syndrome. Under the RPD program, if a future New Drug Application for QRX003 in PSS is approved, Quoin may be eligible for a Priority Review Voucher that can be used, sold, or transferred. The company states that the IND for QRX003 is cleared and it expects to initiate a Phase 2 study in the second half of 2026, enrolling up to 12 pediatric and adult PSS patients in the U.S. and Europe. There are currently no approved treatments for PSS.
Quoin Pharmaceuticals (NASDAQ: QNRX) entered a securities purchase agreement with new and existing healthcare-focused institutional investors for a private placement of up to approximately $50.0 million in gross proceeds. The deal includes upfront funding of about $30.8 million and up to an additional roughly $19.2 million from the potential cash exercise of accompanying ordinary warrants.
Quoin will issue 6,305,300 ADSs (or pre-funded warrants in lieu thereof) plus ordinary warrants to purchase up to 3,152,650 ADSs, at a combined purchase price of $4.88 per ADS and warrant, meeting Nasdaq’s “Minimum Price” rule. The ordinary warrants are immediately exercisable at $6.10 per ADS and will expire five years after closing or 30 days after a public announcement that the primary endpoint has been met in clinical trial CL-QRX003-004 of QRX003 for Netherton Syndrome, whichever occurs first. The private placement is expected to close on or about August 31, 2026, subject to customary conditions. According to Quoin, upfront net proceeds and any warrant exercise proceeds are expected to fund the company into the second half of 2029.
Quoin Pharmaceuticals (NASDAQ: QNRX) reported positive interim data from CL-QRX003-004, its ongoing Phase 2/3, open-label study of QRX003 4% lotion in Netherton Syndrome. In the first six participants completing 12 weeks, the primary endpoint was met: 4 of 6 patients (66.67%; 95% CI 22.28%, 95.67%) achieved at least a 1‑grade improvement in Investigator Global Assessment (IGA) across all treated areas, with statistical significance (p=0.0087 vs pre‑specified α=0.0215).
The key secondary endpoint, a Global Statistical Test of Global Impression of Change, also reached statistical significance at Week 12 with a mean change of -1.5 (SD 0.82; 95% CI -2.3 to -0.6; p=0.007 vs α=0.0215). All three participants who had moderate to severe pruritus at baseline achieved a clinically meaningful ≥3‑grade improvement in Worst Itch Numeric Rating Scale, including one with >6‑grade improvement. Four of six participants showed >25% reductions in Ichthyosis Area and Severity Index, with 31–87% improvement from baseline. QRX003 was generally well tolerated, with no treatment‑related serious adverse events and no clinically significant ECG, lab, or vital sign abnormalities reported. Quoin plans to complete enrollment of approximately 20 evaluable participants by the end of 2026 and report topline data in the second quarter of 2027.
Quoin Pharmaceuticals (NASDAQ: QNRX) reported multiple pipeline milestones and second quarter 2026 results for the period ended June 30, 2026. The FDA granted conditional approval of QYLEKI™ as the proposed brand name for QRX003 for Netherton Syndrome, which holds Orphan Drug, Fast Track and Rare Pediatric Disease designations. Quoin also reported a positive clinical update from its ongoing pediatric compassionate use program and received a U.S. Notice of Allowance for a patent covering a combination treatment for Netherton Syndrome.
For Peeling Skin Syndrome, Quoin submitted the first-ever IND, which the FDA cleared in July 2026, enabling a planned Phase 2/3 study to start in 2H 2026. The QRX009 topical rapamycin platform is advancing toward investigator-led clinical studies in several indications. Quoin reported cash, cash equivalents and investments of approximately $10.8 million and a quarterly net loss of about $5.4 million, and believes existing cash will fund operations into 2027.
Quoin Pharmaceuticals (NASDAQ: QNRX) plans to issue a corporate update and report its second quarter 2026 financial results for the period ended June 30, 2026, before the U.S. market opens on Friday, August 14, 2026.
According to Quoin, the announcement will provide an operational update highlighting key achievements during the quarter, recent accomplishments, and financial highlights. The company describes itself as a late clinical-stage specialty pharmaceutical business focused on rare and orphan diseases, with a pipeline built around its QRX003 and QRX009 platform products targeting multiple dermatologic and other rare indications.