FDA Grants First-Ever Fast Track for Peeling Skin Syndrome Therapy
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 Fast Track Designation for QRX003 in Peeling Skin Syndrome, the first such designation for any PSS therapy. This is the second Fast Track for QRX003, following Netherton Syndrome. The company plans to start a Phase 2/3 study in 2H 2026 with up to 12 patients, targeting approval in 2028. The designation follows July's IND clearance and adds to prior Rare Pediatric Disease Designation. For a micro-cap with a $13.9M market cap, this regulatory milestone strengthens the development path for a disease with no approved treatment.
At the time of this announcement, QNRX was trading at $7.49 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $13.9M. 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 7 out of 10. Source: GlobeNewswire.