Quoin Pharmaceuticals Provides Clinical and Regulatory Update from Constructive Type C Meeting with U.S. FDA for QRX003 in Netherton Syndrome
Quoin Pharmaceuticals, Ltd. - American Depositary Shares (QNRX)
Company Research
Source: GlobeNewswire
FDA indicated that a single Phase 3 study may be sufficient to support marketing approval in the U.S. FDA expressed openness to an alternative study design for Phase 3 that would likely not include a traditional upfront vehicle or placebo control Quoin remains on track to initiate a Phase 3 study and complete Phase 3 patient recruitment in 2026 and potentially file for NDA approval in 2027 ASHBURN, Va., March 25, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today provided a clinical and regulatory update from its recent constructive Type C meeting with the U.S. Food and Drug Administration (FDA) for its lead product candidate, QRX003, for the treatment of Netherton Syndrome (NS). “We are very pleased to provide this update from our recent Type C meeting with FDA. Importantly, FDA acknowledged that a single Phase 3 study may be sufficient
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News
- Quoin Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full-Year 2025 Financial ResultsGlobeNewswire
- Quoin Pharmaceuticals to Announce Corporate Update and Fourth Quarter and Full-Year 2025 Financial Results on Thursday, March 26, 2026GlobeNewswire
- Quoin Pharmaceuticals Announces FDA Grants Fast Track Designation for QRX003 for the Treatment of Netherton Syndrome [Yahoo! Finance]Yahoo! Finance
- Quoin Pharmaceuticals Announces FDA Grants Fast Track Designation for QRX003 for the Treatment of Netherton SyndromeGlobeNewswire
- NETHERTON NOW Recognizes Rare Disease Day and Highlights Growing Global Awareness of Netherton Syndrome [Yahoo! Finance]Yahoo! Finance
QNRX
Sec Filings
- 3/26/26 - Form 10-K
- 3/26/26 - Form 8-K
- 3/11/26 - Form 8-K
- QNRX's page on the SEC website