Quoin Pharmaceuticals Ltd Stock Price, News & Analysis

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.

Quoin Pharmaceuticals (NASDAQ: QNRX) has reported positive initial clinical data from its ongoing Investigator Pediatric Peeling Skin Syndrome study for QRX003. After 12 weeks of treatment, the study showed significant improvements across multiple endpoints:

- Modified Ichthyosis Area Severity Index (M-IASI) improved from 36 to 12 - Investigator's Global Assessment (IGA) improved from severe (4) to mild (2) - Children's Dermatology Life Quality Index (CDQLI) improved from 19 to 11

The treatment was well-tolerated with no adverse events reported. Based on these positive results, the patient will continue treatment with QRX003, with another assessment scheduled after 24 weeks. This study may be the first formal clinical trial for Peeling Skin Syndrome, a rare genetic disease with no currently approved treatments.

Quoin Pharmaceuticals (NASDAQ: QNRX) reported Q1 2025 financial results and corporate updates, highlighting significant progress in their QRX003 clinical trials for Netherton Syndrome. Key developments include:

The company demonstrated compelling clinical data showing almost complete skin healing and reduction/elimination of pruritus in both adult and pediatric patients. Notably, pediatric patients were able to discontinue previously required medications. The studies confirmed QRX003's mechanism of action as a broad-spectrum serine protease inhibitor.

Financial highlights show a cash position of $11.6 million as of March 31, 2025, expected to fund operations into Q1 2026. The company reported a net loss of $3.8 million for Q1 2025, compared to $2.3 million in Q1 2024.

Quoin expanded its patent portfolio and launched NETHERTON NOW, a community awareness initiative. The company is preparing for additional international clinical sites and a new FDA-cleared study at Northwestern University evaluating whole-body QRX003 application in 8-12 patients.

Quoin Pharmaceuticals (NASDAQ: QNRX), a late clinical-stage specialty pharmaceutical company specializing in rare and orphan diseases, has scheduled the release of its Q1 2025 financial results for Tuesday, May 13, 2025, before market opening. The company will provide a comprehensive update including the quarter's key achievements, recent accomplishments, and financial performance for the period ending March 31, 2025.

Quoin Pharmaceuticals (NASDAQ: QNRX), a late clinical stage specialty pharmaceutical company, has successfully regained compliance with Nasdaq's minimum bid price requirement. The company, which focuses on developing treatments for rare and orphan diseases, received official confirmation from Nasdaq's Listing Qualifications Department.

The achievement was marked by the company's ordinary shares maintaining a closing bid price of $1.00 or higher for 13 consecutive business days, meeting the criteria under Nasdaq Listing Rule 5550(a)(2). With this requirement satisfied, Nasdaq has formally closed the matter, ensuring Quoin's continued listing on the exchange.