aibioQuoin reports first quarter 2026 results and FDA meeting outcome
Tickers QNRX
Quoin said an FDA Type C meeting indicated a single Phase 3 study may be sufficient for U.S. approval of QRX003, and reported approximately $14 million in cash as of March 31, 2026.
Key facts
- Company
- Quoin Pharmaceuticals, Ltd. (NASDAQ: QNRX)
- News type
- Company Updates
- Primary source
- Quoin Pharmaceuticals, Ltd. 8-K (2026-05-07)
Regulatory progress
On May 7, 2026, Quoin Pharmaceuticals, Ltd. (NASDAQ: QNRX) reported corporate achievements and a first quarter 2026 update for the period ended March 31, 2026. The most significant item, in the company's telling, was the outcome of a Type C meeting with the U.S. Food and Drug Administration, which Quoin reported on March 25, 2026. The company said the FDA indicated that a single Phase 3 study may be sufficient to support marketing approval for QRX003 in the United States. The FDA also expressed openness to an alternative study design, such as a randomized withdrawal or randomized delayed start, that would likely not include a traditional upfront vehicle or placebo control.
On March 11, 2026, the FDA granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome. The company said Fast Track status enables more frequent interactions with the FDA and eligibility for rolling review of regulatory submissions, with potential qualification for Accelerated Approval and Priority Review if relevant criteria are met. Separately, Congress extended the U.S. Rare Pediatric Disease Priority Review Voucher program through September 30, 2029 on February 3, 2026. Quoin said that upon approval of QRX003 it would be eligible to receive a voucher under that program.
Quoin also reported two filings outside the United States. On January 27, 2026, it submitted an application to Japan's Ministry of Health, Labour and Welfare seeking Orphan Drug Designation. On January 20, 2026, Quoin filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority.
Pipeline and QRX009
Quoin said it remains on track to complete patient recruitment into its Phase 3 program by the end of 2026 and to file for FDA approval of QRX003 in 2027. The release said QRX003 lotion (4%) continues to be evaluated in late-stage whole-body clinical trials, with topline data anticipated in the second half of 2026. The ongoing pediatric investigator-led study has been expanded to six children being treated with QRX003 in Ireland, Austria, the Netherlands and New Zealand.
For Peeling Skin Syndrome, the investigator-led study has been expanded to six subjects, and the company planned to submit an IND to the FDA for that indication in the second quarter of 2026. Quoin's second platform, QRX009, is a topical rapamycin program. Investigator-led studies are being planned for Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, and Quoin is targeting an IND to the FDA for QRX009 in an additional indication in the third quarter of 2026.
Financial position
Quoin said it had approximately $14 million in cash, cash equivalents and marketable securities as of March 31, 2026, and that its current cash position will fund operations into 2027. The net loss for the quarter ended March 31, 2026 was approximately $5 million, compared with approximately $3.8 million for the quarter ended March 31, 2025.
The annual report filed March 26, 2026 shows research and development expense of $9.8 million for 2025, against $3.6 million for 2024, and a net loss of $15.8 million, against $9.0 million.
The risks ahead
Quoin has no approved product and no revenue, according to its annual report. The company calls the FDA meeting "constructive", but the FDA said only that a single Phase 3 study "may be" sufficient. That is feedback, not a binding agreement or a marketing approval. A design without a traditional vehicle or placebo control may be easier to run, but the evidence would not come from the usual blinded comparison. Fast Track status and the voucher do not amount to approval, and the voucher comes only upon approval.
The release gives no efficacy data for QRX003, and the pediatric studies are small: six children with Netherton Syndrome and six subjects with Peeling Skin Syndrome, in investigator-led work. The company says it is on track to complete Phase 3 recruitment by the end of 2026 and to file for approval in 2027, yet it describes its cash of about $14 million at March 31, 2026 as funding operations only into 2027. Cash used in operations was $13.5 million for 2025, against $7.9 million for 2024, and the first quarter net loss was approximately $5 million.