Quoin Pharmaceuticals Garners Buzz After FDA’s Comments On Netherton Syndrome Lead Drug

• The FDA indicated openness to alternative trial designs such as not using a placebo group for the Phase 3 trial.
• Quoin remains on track to complete patient enrollment for the next phase, it added.
• Last week, the FDA granted Fast Track designation to the company’s QRX003.

Shares of Quoin Pharmaceuticals (QNRX) gave up most of its early gains to trade 1 % higher 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 like randomized withdrawal or delayed-start studies, instead of a traditional placebo-controlled Phase 3 trial.

Phase 3 Trial Remains On Track

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.

This comes just a week after the FDA granted Fast Track designation to QRX003. The drug is currently being tested in two late-stage trials to evaluate safety and effectiveness. QRX003 has already received Orphan Drug status in both the U.S. and Europe.

Quoin also submitted an Orphan Drug Designation (ODD) application for QRX003 in Japan and a Breakthrough Medicine Designation with the Saudi Food and Drug Authority earlier this year.

How Did Stocktwits Users React?

Retail sentiment for QNRX flipped to ‘extremely bullish’ from ‘bearish’ a day earlier, amid ‘extremely high’ message volumes.

One user said given the company’s potential, the stock has been “beaten down”

The stock has been under heavy selling pressure this year, slumping around 45%.

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