Quoin Pharmaceuticals secured the first-ever Fast Track Designation for a Peeling Skin Syndrome therapy, with a Phase 2/3 trial set to start by

Study CL-QRX003-002 will test whole-body application of QRX003 in conjunction with off-label systemic therapy in approximately 12-15 subjects. Study CL-QRX003-002 complements first whole-body pivotal study, CL-QRX003-003, being led by Dr. Amy Paller at Northwestern University and supported by up to

FDA greenlights Quoin's pivotal clinical trial for QRX003, a potential first-ever treatment for Netherton Syndrome. Study aims to demonstrate real-world efficacy.

Quoin Pharma's QRX003 demonstrates significant symptom reduction in Netherton Syndrome patients, with rapid improvements in severity scores and no safety concerns.

Click to view the official SEC document.

Reported Tuesday, Sep 22 - 8:42am EDT (TheFly subscription required to read more.)

Quoin Pharmaceuticals announces additional positive interim data from its ongoing open-label Netherton Syndrome clinical study. The study involves QRX003, a treatment administered twice daily. After 12 weeks, the first subject showed significant improvements across all measured clinical endpoints:M-IASI: Reduced from 18 to 3 (lower scores indicate improvement)WINRS: Decreased from 7 to 2 (measures itch severity on an 11-point scale)IGA: Improved from 'Moderate' to 'Almost Clear'Photographs demonstrating the subject's skin improvements are available on Quoin's website. No safety concerns were identified during the study. Patient satisfaction scores were highly positive and improved further after 12 weeks. Quoin CEO, Dr. Michael Myers, expressed excitement over the results, highlighting the potential efficacy of QRX003 and the absence of safety issues. The company is preparing for a 'whole body' clinical study at Northwestern University, with FDA clearance already obtained. Data from this study will support a New Drug Application for QRX003 as the first approved treatment for Netherton Syndrome. Quoin anticipates providing more updates throughout 2025.

Stock Titan provides an ultra-fast stock market news feed and multiple tools for traders and investors.

Click to view the official SEC document.

Reported Tuesday, Sep 8 - 9:04am EDT (TheFly subscription required to read more.)

Stock Titan provides an ultra-fast stock market news feed and multiple tools for traders and investors.

Quoin's topical serine protease inhibitor met both primary and key secondary endpoints in six Netherton Syndrome patients after 12 weeks of treatment.

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.

Reported Friday, Aug 28 - 6:02am EDT (TheFly subscription required to read more.)

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.