Shares of Quoin Pharmaceuticals (QNRX) surged more than 20% in pre-market trading on Wednesday, after the company said it has received encouraging feedback from the U.S. Food and Drug Administration (FDA) for its lead drug QRX003 to treat Netherton Syndrome, a genetic disorder that results in severe allergies.
The FDA indicated that a single Phase 3 trial may be sufficient to support U.S. approval, rather than the usual two studies. The agency also showed openness to alternative trial designs that may not require a traditional placebo group, the company said.
Following the Type C meeting, Quoin plans to move ahead with its Phase 3 program and remains on track to complete patient enrollment. The company said it could file for approval as early as 2027.
“With our established network of U.S. and EU clinical trial sites, we are confident that we will be in a position to initiate our pivotal Phase 3 program and fully complete recruitment this year,” said CEO Michael Myers.
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