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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 (NASDAQ: QNRX) reported significant progress in 2024, particularly with its lead product QRX003 for Netherton Syndrome. Clinical trials showed promising results, including dramatic reduction in disease severity and skin healing. The company recently received FDA clearance for a 'whole-body' clinical study.
Key developments include filing patent applications for novel topical rapamycin formulations, launching the 'NETHERTON NOW' awareness campaign, and completing a $6.8 million public offering. Positive clinical data showed treatment effectiveness with QRX003, with improvements reversing after discontinuation, supporting the need for chronic treatment.
Financial results show cash position of $14.1 million as of December 31, 2024, expected to fund operations into Q2 2026. Net loss for Q4 2024 was $2.3 million, compared to $2.0 million in Q4 2023, while full-year 2024 net loss was $9.0 million versus $8.7 million in 2023.
Quoin Pharmaceuticals (NASDAQ: QNRX), a late clinical-stage specialty pharmaceutical company specializing in rare and orphan diseases, has scheduled the release of its Q4 and full-year 2024 financial results for Thursday, March 13, 2025, before market opening.
The upcoming announcement will feature an operational update covering key quarterly achievements, recent accomplishments, and financial highlights from 2024.
Quoin Pharmaceuticals (NASDAQ: QNRX) has filed U.S. and International patent applications for novel topical rapamycin formulations targeting rare diseases including microcystic lymphatic malformations, venous malformations, and angiofibromas. The formulations utilize the proprietary Invisicare delivery technology, designed to optimize skin penetration of rapamycin into the dermis.
The company plans to submit Investigational New Drug (IND) applications and begin clinical testing in 2025 for at least two target indications. Currently, there are no FDA-approved treatments for microcystic lymphatic malformations or venous malformations.
Quoin is also advancing clinical trials for QRX003, their lead product using the same Invisicare technology, which is being tested as a potential first-approved treatment for Netherton Syndrome. The company is actively enrolling patients in three clinical trials under an open IND application for QRX003.
Quoin Pharmaceuticals (NASDAQ: QNRX) has reported significant clinical data from its ongoing Investigator Pediatric Netherton Syndrome (NS) study for QRX003. The first pediatric patient receiving whole-body application showed dramatic improvement after just two weeks of treatment.
Key findings include:
- Investigator's Global Assessment (IGA) improved from 5 to 1 on a 0-10 scale
- Pruritus (itch) score decreased from 7 to 1-2 on a 0-10 scale
- Patient discontinued previously required medications including antihistamines, glucocorticoids, and antivirals
- No antibiotics needed since treatment initiation
- Zero nightly sleep disturbances reported for the first time
- No adverse events observed with twice-daily whole-body application
The company plans to expand the study to include additional pediatric subjects in other countries.
Quoin Pharmaceuticals (NASDAQ: QNRX) announced the launch of its "Living with Netherton" video series, part of the broader NETHERTON NOW campaign. The first episode will premiere on Rare Disease Day, February 28, 2025, featuring Carmon McTigue's story about her son's difficult journey with Netherton Syndrome.
The series aims to raise awareness about this devastating genetic disorder caused by mutations in the SPINK5 gene, which leads to excessive skin shedding, painful inflammation, recurrent infections, and other complications. Up to 20% of babies born with this condition do not survive.
Carmon's story highlights the challenges families face, including delayed diagnosis, misdiagnosis, and lack of treatment options. Her son was hospitalized 15-20 times in his early years due to severe infections.
Quoin's lead candidate, QRX003, is currently being evaluated in four clinical trials, with recent data showing potential efficacy. The video will premiere globally on YouTube at various times across different time zones, with the NETHERTON NOW website serving as a resource hub for patients and families.
Quoin Pharmaceuticals (NASDAQ: QNRX) has launched the 'NETHERTON NOW' campaign to raise awareness about Netherton Syndrome, a rare genetic disease with no approved treatment. The condition affects newborns, with up to 20% mortality rate, causing excessive skin shedding, painful itching, and severe infections.
The company is currently conducting four clinical studies evaluating QRX003, their potential treatment for Netherton Syndrome. Recent clinical data has shown promising results, including photographic evidence of improvement after 12 weeks of treatment. A significant 'whole body' clinical study at Northwestern University, cleared by the FDA, is set to begin.
The campaign includes an interactive website serving as a resource hub for patients and families, providing educational materials and research updates. The initiative aims to address the challenges of diagnosis delays and lack of awareness while supporting the Netherton community through advocacy and education. Interested participants can sign up for clinical study alerts at nethertonnow.com.
Quoin Pharmaceuticals (NASDAQ: QNRX) has announced additional clinical evidence regarding QRX003's effectiveness in treating Netherton Syndrome. After observing positive results during a 12-week treatment period, the company reported that all clinical benefits were completely reversed within 4 weeks of treatment discontinuation.
The clinical data shows that the first subject, who received twice-daily doses, experienced significant improvements across all measured endpoints during the treatment period. The Modified Ichthyosis Area of Severity Index (M-IASI) improved from 18 to 3, the Worst Itch Numeric Rating Scale (WINRS) decreased from 7 to 2, and the Investigator's Global Assessment (IGA) improved from Moderate to Almost Clear. However, these metrics reverted to baseline levels after treatment stopped.
The results indicate that chronic, whole-body treatment with QRX003 is necessary for maintaining positive clinical outcomes in Netherton Syndrome patients. Quoin currently has four clinical studies underway, with three under FDA IND applications, aiming to develop the first approved treatment for this condition.
Skinvisible Pharmaceuticals (OTCQB:SKVI) reports significant progress through its licensee Quoin Pharmaceuticals' advancement in Netherton Syndrome treatment. The company's proprietary Invisicare® technology and formulation, licensed to Quoin, has shown positive results in clinical studies. Key developments include FDA clearance for a 'whole body' study at Northwestern University and significant clinical improvements in both open label and pediatric studies, where subjects' conditions improved from 'severe' to 'mild' after 6 weeks of treatment.
The treatment, QRX003, has been licensed in 60 countries with studies expanding to UK, Ireland, and Saudi Arabia. Upon FDA or EU approval, Skinvisible will receive a $5 million milestone payment plus ongoing royalties from sales. No adverse events or safety concerns have been reported in the ongoing clinical studies.
Quoin Pharmaceuticals (NASDAQ: QNRX) reported positive interim clinical data from its ongoing Investigator Pediatric Netherton Syndrome study of QRX003. The study demonstrated significant improvement in treated skin areas, with the subject's condition improving from 'Severe' to 'Mild' after six weeks of twice-daily treatment.
Due to these positive results, the treatment area has been expanded from 20% to the whole body surface area (BSA). No adverse events or safety concerns have been reported, consistent with other ongoing Netherton Syndrome clinical studies. The Investigator's Global Assessment (IGA) showed improvement from 'Severe' at baseline to 'Mild-Moderate' after 12 days, progressing to 'Mild' after 6 weeks.
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.