FDA Grants Rare Pediatric Disease Designation for QRX003 in Peeling Skin Syndrome
QNRX has more than doubled off its 52-week low of $3.25 on light trading volume (0.1× avg).
Summary
Quoin Pharmaceuticals received FDA Rare Pediatric Disease Designation for QRX003 in Peeling Skin Syndrome, its second such designation after Netherton Syndrome. This designation could yield two Priority Review Vouchers worth over $300 million in aggregate if the drug is approved, a significant non-dilutive cash opportunity for a company with a market cap around $14.6 million. The company plans to initiate a Phase 2 study for PSS before year-end, enrolling up to 12 patients in the U.S. and Europe. This follows the FDA's IND clearance for QRX003 in PSS in July and positive interim Phase 2/3 data in Netherton Syndrome in August. The designation strengthens the regulatory pathway and potential monetization of PRVs, which could materially improve the company's financial position.
At the time of this announcement, QNRX was trading at $7.56 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $14.6M. The 52-week trading range was $3.25 to $41.80. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.