Quoin Pharmaceuticals (QNRX) Stock News

Quoin Pharmaceuticals (NASDAQ: QNRX) has appointed Sally Lawlor as its new Chief Financial Officer, effective immediately. Lawlor brings over 20 years of financial leadership experience, including her recent role at Sebela Pharmaceuticals and positions at Aptiv Plc and KPMG.

The appointment comes as Quoin advances its lead product QRX003 through pivotal clinical trials for Netherton Syndrome, with full enrollment expected in early to mid-Q1 2026. The company is preparing for a potential NDA filing next year and transition to a commercial-stage organization. Additionally, Quoin is developing treatments for Peeling Skin Syndrome and other rare dermatologic diseases through a novel topical rapamycin platform.

Quoin Pharmaceuticals (NASDAQ: QNRX) has released the fourth episode of its NETHERTON NOW video series, featuring Mandy Aldwin-Easton, a prominent patient advocate and leader in rare disease advocacy organizations. The episode highlights the devastating impact of Netherton Syndrome, a rare skin condition characterized by severe pain, chronic flare-ups, and frequent hospitalizations.

Mandy, who serves as Medical and Communications Manager of the UK-based Ichthyosis Support Group and President of the European Network for Ichthyosis, shares her personal journey with the condition. The release coincides with Quoin's advancement of QRX003, their lead product candidate for Netherton Syndrome treatment, which has shown promising results in ongoing pivotal clinical trials.

Quoin Pharmaceuticals (NASDAQ: QNRX) reported significant progress in Q2 2025 for its lead drug candidate QRX003. The company announced positive 6-month clinical data from its pediatric Netherton Syndrome study, showing significant skin improvements and reduced itching with no adverse events. The FDA cleared a second pivotal study for Netherton Syndrome, while initial positive data emerged from a Peeling Skin Syndrome study.

Notable regulatory achievements include receiving Orphan Drug Designation from the European Medicines Agency and Rare Pediatric Disease Designation from the FDA. Financially, Quoin reported $7.8 million in cash as of June 30, 2025, with runway into Q1 2026, and a Q2 net loss of $3.7 million primarily due to increased R&D spending.

[ "Positive 6-month clinical data from pediatric Netherton Syndrome study showing significant improvements", "FDA clearance for second pivotal study of QRX003", "Positive initial data from Peeling Skin Syndrome study", "Secured European Orphan Drug Designation providing 10 years market exclusivity", "Obtained FDA Rare Pediatric Disease Designation enabling Priority Review Voucher eligibility", "$7.8M cash runway extending into Q1 2026" ]

Quoin Pharmaceuticals (NASDAQ: QNRX), a late clinical-stage specialty pharmaceutical company specializing in rare and orphan diseases, has scheduled its Q2 2025 financial results release for August 7, 2025, before market opening.

The upcoming announcement will feature both financial results for the quarter ending June 30, 2025, and an operational update covering the company's key achievements and recent milestones.

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) has released a new episode of its NETHERTON NOW video series featuring Professor Jemima Mellerio, a leading expert in genetic skin diseases. The video highlights the severe challenges of Netherton Syndrome, particularly in infants and children.

The release follows Quoin's recent achievement of Rare Pediatric Disease Designation from the FDA for its lead product candidate QRX003, which complements its existing Orphan Drug status from the EMA. Professor Mellerio emphasizes that Netherton Syndrome is a serious genetic condition with associated mortality, especially in young patients, requiring intensive daily treatment.

Quoin Pharmaceuticals (NASDAQ: QNRX) has received Rare Pediatric Disease (RPD) Designation from the FDA for its lead asset QRX003, targeting Netherton Syndrome. This follows the Orphan Drug Designation granted by the European Medicines Agency in May 2025.

The RPD designation could make Quoin eligible for a Priority Review Voucher upon potential New Drug Application approval. The company reports encouraging efficacy data and safety profile from ongoing pivotal clinical studies for QRX003, which aims to be the first treatment for this severe genetic disease primarily affecting children under 18.

Quoin Pharmaceuticals (NASDAQ: QNRX) has received FDA clearance to initiate a second pivotal clinical study (CL-QRX003-002) for its lead product QRX003 in treating Netherton Syndrome. The new study will test whole-body application of QRX003 alongside off-label systemic therapy in 12-15 subjects. This complements their first pivotal study (CL-QRX003-003) led by Dr. Amy Paller at Northwestern University, testing QRX003 as monotherapy. Earlier clinical data showed rapid skin healing and symptom reduction with QRX003. The company has opened five U.S. clinical sites and is preparing six international sites, with patient cohorts ready for enrollment. Quoin aims to complete recruitment for both studies by Q1 2026 and file an NDA later that year. Combined, the studies will involve 24-30 subjects and could provide QRX003 with the broadest possible label opportunity post-approval.

Quoin Pharmaceuticals (NASDAQ: QNRX) has received Orphan Drug Designation from the European Medicines Agency (EMA) for QRX003, its lead product targeting Netherton Syndrome. This designation provides significant benefits including 10 years of market exclusivity in Europe upon approval, along with scientific advice on study protocols, fee reductions, and access to EU grants. QRX003, currently in late-stage clinical trials, is designed as a topical, non-systemic treatment for Netherton Syndrome, a rare disease with no approved therapies. The company reports encouraging clinical results, noting significant skin healing and almost complete elimination of severe chronic pruritus in their pediatric study. QRX003 functions as a broad spectrum kallikrein inhibitor, demonstrating both efficacy and a clean safety profile in ongoing studies.