Quoin Pharmaceuticals rises on FDA feedback; single Phase 3 trial may support QRX003 approval in Netherton syndrome

Reuters03-25
<a href="https://laohu8.com/S/QNRX">Quoin Pharmaceuticals</a> rises on FDA feedback; single Phase 3 trial may support QRX003 approval in Netherton syndrome
  • Quoin Pharmaceuticals said the U.S. FDA indicated that a single Phase 3 study may be sufficient to support marketing approval for QRX003 in Netherton Syndrome.
  • The FDA expressed openness to an alternative Phase 3 design, such as a randomized withdrawal or randomized delayed start study, that would likely not include a traditional upfront vehicle or placebo control.
  • The company plans to submit clinical data from its ongoing Phase 2 and pediatric investigator studies and request a meeting to discuss the data before starting the Phase 3 pivotal program.
  • Quoin Pharmaceuticals said it remains on track to initiate Phase 3 and complete Phase 3 patient recruitment in 2026, and it could file for NDA approval in 2027.
  • The update did not state that new clinical results have already been presented, and it did not specify when future results will be presented.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Quoin Pharmaceuticals Ltd. published the original content used to generate this news brief on March 25, 2026, and is solely responsible for the information contained therein.

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