Quoin Pharmaceuticals (QNRX) Stock News

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.

Quoin Pharmaceuticals (NASDAQ: QNRX) has released the second episode of its 'Living with Netherton' video series, featuring 79-year-old Norma Coles, one of the earliest patients evaluated for Netherton Syndrome. The episode is part of the company's NETHERTON NOW awareness campaign.

Norma's remarkable story spans nearly eight decades, having been initially examined by Dr. Edward Netherton at the Cleveland Clinic in the late 1940s. Despite experiencing symptoms like fragile skin, recurring rashes, and 'bamboo hair,' she wasn't officially diagnosed until her mid-50s.

The company's lead product candidate, QRX003, is currently undergoing four clinical trials for Netherton Syndrome treatment. Initial data shows promising results, including improvements in skin healing, reduction in inflammation and pruritus, and enhanced quality of life. Quoin aims to develop the first FDA-approved treatment for this rare genetic disorder, as currently no approved treatments exist.

Quoin Pharmaceuticals (NASDAQ: QNRX) has reported additional positive clinical data from its ongoing pediatric Netherton Syndrome (NS) study of QRX003. After 6 weeks of whole-body treatment, the first patient's skin remains almost completely healed, demonstrating treatment durability.

Key outcomes include:

• Elimination of previously required medications (antibiotics, antivirals, antihistamines, glucocorticoids)
• Almost complete elimination of pruritus (itching)
• Zero nightly sleep disturbances without sedating medication
• No adverse events reported after 6 weeks

Based on these positive results, Quoin has received approval to begin whole-body QRX003 treatment on a second pediatric NS patient, with testing expected to commence within weeks.

Quoin Pharmaceuticals (NASDAQ: QNRX) has filed a U.S. patent application for novel topical formulations targeting multiple skin diseases, including Netherton Syndrome (NS). The company's lead product, QRX003, is currently undergoing testing in four clinical trials, with three conducted under FDA's Investigational New Drug (IND) application.

The patent application extends to other conditions including Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, and Severe Atopic Dermatitis. If granted, this would be Quoin's third patent for Netherton Syndrome, providing protection until 2045. The company has reported positive initial clinical data from two open-label studies and is conducting a pediatric NS patient study at Dublin's Children's Hospital, with plans to expand to Spain, UK, and other countries.