aibioFDA conditionally accepts QYLEKI as the brand name for QRX003
Tickers QNRX
The FDA conditionally accepted QYLEKI as the proposed brand name for QRX003 in Netherton Syndrome, and the company says a pivotal Phase 3 study is expected to start in the second half of 2026.
Key facts
- Company
- Quoin Pharmaceuticals, Ltd. (NASDAQ: QNRX)
- News type
- Company Updates
- Primary source
- Quoin Pharmaceuticals, Ltd. 8-K (2026-06-23)
The brand name
On June 23, 2026, Quoin Pharmaceuticals, Ltd. (NASDAQ: QNRX) said the U.S. Food and Drug Administration had conditionally accepted QYLEKI as the proposed brand name for QRX003, its investigational topical treatment for Netherton Syndrome. The company said a request for proprietary name review and final approval of the name will be included in a New Drug Application for QRX003. Final approval of the QYLEKI name will be obtained upon FDA marketing approval of the product. Quoin said the name was developed in accordance with the FDA's guidance on proprietary names. The release says the name is pronounced Key-Lek-ee.
Dr. Michael Myers, Chief Executive Officer and Co-Founder, said that "FDA conditional approval of the QYLEKI brand name reflects the continued progress we are making toward potential commercialization of the product". He described the designation of a brand name as an important step for Quoin, its commercial partners and the Netherton community.
Regulatory recognition
QRX003 holds Orphan Drug Designation in the United States, the European Union and Japan. The FDA has also granted QRX003 Fast Track and Rare Pediatric Disease Designations. Quoin said these designations give regulatory recognition across its three core commercial territories. QYLEKI lotion (4%) is currently being evaluated in Phase 2 whole-body clinical trials in patients with Netherton Syndrome.
The company also pointed to a positive clinical update from its Pediatric Compassionate Use Program, released on June 16, 2026. The sources give no patient numbers, endpoints or statistical results for that update. The annual report says QRX003 is being tested in seven pediatric patients in investigator-initiated studies, and describes no control group.
Netherton Syndrome is described in the release as a rare, inherited skin disorder caused by mutations in the SPINK5 gene. It leads to severe skin barrier dysfunction, chronic inflammation and a heightened risk of infections and allergic complications. Patients often have widespread skin redness, scaling and persistent itching, with significant impairment in quality of life. The release states there are currently no FDA-approved therapies for the condition, and that treatment is limited to supportive care and off-label therapies.
Timeline and financial position
Quoin's pivotal Phase 3 study is expected to initiate in the second half of 2026, with a potential NDA filing in 2027. The annual report for 2025, filed March 26, 2026, describes QRX003 as entering pivotal registrational clinical testing under an open Investigational New Drug application. It says the company has opened six clinical sites in the United States, with international sites being opened in the UK, Spain, France and the Netherlands.
The same report shows research and development expense of $9.8 million for 2025, against $3.6 million for 2024. The net loss was $15.8 million for 2025 and $9.0 million for 2024. Cash used in operations was $13.5 million for 2025 and $7.9 million for 2024. At December 31, 2024, the company reported cash and cash equivalents of $3.6 million and short-term investments of $10.4 million. The annual report states that no products have been commercialized and no revenue has been generated to date.
The risks ahead
The name is conditional, and it carries no information about whether the drug works. Final approval of QYLEKI comes only with FDA marketing approval, which has not been sought: no New Drug Application has been filed. QRX003 is still in Phase 2 whole-body trials. The pivotal Phase 3 study has not started, and the company's own timing is a start in the second half of 2026 and a possible NDA filing in 2027. The release leads with a name, not with efficacy or safety data.
The company has no revenue, and the annual report says no product has been commercialized. It shows a net loss of $15.8 million and cash used in operations of $13.5 million for 2025, up from $9.0 million and $7.9 million in 2024. The release does not say how the later studies will be paid for.