Quoin Pharmaceuticals Ltd. engages in the development of therapeutic products for the treatment of rare and orphan diseases. Its product pipeline includes QRX003, QRX004, QRX007, and QRX008. The company was founded by Michael Myers and Denise Carter on March 5, 2018 and is headquartered in Ashburn, VA.
Clinical Trials
4
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
25.0%
Recruiting
3
75.0%
No approval data available
- The FDA granted Fast Track Designation to Quoin Pharmaceuticals' topical serine protease inhibitor lotion QRX003 for Peeling Skin Syndrome, the first such designation for the disease. - It is the second Fast Track Designation for QRX003, following the March 11, 2026 designation for Netherton Syndrome, and follows July 2026 clearance of the first-ever PSS IND. - Quoin plans to start a Phase 2/3 study in the second half of 2026 enrolling up to 12 pediatric and adult patients in the United States and Europe. - The IND was supported by an ongoing investigator-led single-subject pediatric study showing improvements in skin severity, pruritus and quality of life after more than 15 months of dosing with no adverse events.
- The FDA granted Rare Pediatric Disease designation to Quoin Pharmaceuticals' topical candidate QRX003 for Peeling Skin Syndrome, an inherited disorder with no approved treatment. - It is the second such designation for QRX003, which previously received the same status for Netherton Syndrome and Orphan Drug status from the European Medicines Agency. - Quoin plans to start a Phase 2 study before the end of 2026, enrolling up to 12 pediatric and adult patients in the U.S. and Europe under a cleared IND.
- Quoin Pharmaceuticals' stock jumped 66.83% following FDA Orphan Drug Designation for QRX003 to treat Netherton Syndrome, a rare genetic skin condition. - The company has strengthened its financial position with a cash runway extending into 2027, supporting continued research and development activities. - QRX003 also received similar orphan drug recognition from the European Medicines Agency, enhancing the drug's regulatory pathway across major markets. - The designation provides potential market benefits including tax credits, enhanced patent protection, and exclusivity periods for the rare disease treatment.
- Quoin Pharmaceuticals successfully achieved target rapamycin loading concentrations of 4% w/w in topical lotion and 5% w/w in dermal patch formulations. - The company plans to commence clinical trial manufacturing in Q4 2025 and begin clinical testing in the first half of 2026 for microcystic lymphatic malformations and venous malformations. - These rare conditions currently have no FDA-approved treatments, with lymphatic malformations affecting 1 in 6,000 to 16,000 patients and venous malformations having an incidence of 1 to 2 in 10,000.
- A new Q4 2025 Catalyst Monitor report identifies 20 significant market-moving events expected in the fourth quarter, based on key opinion leader interviews and predictive intelligence. - Major approval decisions are anticipated for Cytokinetics' aficamten for obstructive hypertrophic cardiomyopathy and Aldeyra's reproxalap for keratoconjunctivitis sicca. - GSK's depemokimab faces regulatory decisions for chronic rhinosinusitis and asthma, while ongoing trials include Sanofi's tolebrutinib for primary progressive multiple sclerosis. - The report covers trial initiations, completions, top-line results, regulatory filings, PDUFA dates, and expected approvals across diverse therapeutic areas.
- Quoin Pharmaceuticals announced that the FDA has granted Orphan Drug Designation to QRX003, its lead product candidate for treating Netherton Syndrome. - The FDA designation follows a similar Orphan Drug Designation previously granted by the European Medicines Agency in May 2025. - QRX003 lotion is currently being evaluated in two late-stage whole body pivotal clinical trials with enrollment completion expected in Q1 2026. - The company anticipates top-line data in the second half of 2026 and plans to submit an NDA later in the year.
- Quoin Pharmaceuticals has appointed Sally Lawlor as Chief Financial Officer, bringing over 20 years of pharmaceutical finance experience to guide the company through commercialization preparations. - The appointment comes as Quoin advances QRX003 through two pivotal clinical studies for Netherton Syndrome, with full enrollment expected in early to mid-Q1 2026. - QRX003 has received regulatory advantages including Orphan Drug Designation from the EMA and Rare Pediatric Disease Designation from the FDA. - The company reported $7.8 million in cash as of June 30, 2025, providing operational runway into Q1 2026 as it prepares for potential commercialization.
- Quoin Pharmaceuticals' QRX003 demonstrates significant symptom reduction in a Netherton Syndrome clinical trial, with an 83% improvement observed in the first subject after 12 weeks. - The open-label study showed improvements across multiple clinical endpoints, including M-IASI, WINRS, and IGA, with no reported safety concerns and high patient satisfaction. - The FDA has cleared Quoin to begin a 'whole body' clinical study at Northwestern University, with data expected to support a New Drug Application for QRX003. - QRX003 is a topical lotion designed to normalize skin shedding and strengthen the skin barrier in Netherton Syndrome patients, potentially becoming the first approved treatment.
- Quoin Pharmaceuticals is assessing QRX003 in a pediatric patient with Netherton Syndrome (NS), addressing the need for early treatment in this rare genetic disease. - The company is expanding its clinical activities internationally, with new sites in Saudi Arabia and the UK, to accelerate recruitment and diversify the patient population. - QRX003 is also being studied in a pediatric patient with Peeling Skin Syndrome (PSS) in New Zealand, potentially leading to the first approved treatment for PSS. - Quoin's CEO and COO increased their investment in QNRX shares, signaling confidence in the company's prospects and the potential of QRX003.
- Quoin Pharmaceuticals initiates an investigator-led clinical study in New Zealand to evaluate QRX003 for Peeling Skin Syndrome, a condition with no approved treatments. - The company is expanding its Netherton Syndrome clinical program internationally, opening two additional sites in the United Kingdom. - Quoin's management team has made significant insider share purchases, reflecting confidence in the company's growth and long-term value. - With $10.3 million in cash, Quoin expects to fund operations into late 2025 and continues to assess M&A opportunities in the rare disease space.
