Quoin reports Q2 2026 results, FDA clearance for peeling skin syndrome IND
Quoin Pharmaceuticals said the FDA cleared its IND for Peeling Skin Syndrome after quarter end, setting up a Phase 2/3 study to start in the second half of 2026.
Quoin Pharmaceuticals Ltd. reported second quarter 2026 results on August 14, 2026, alongside a string of regulatory updates for its QRX003 and QRX009 programs.
For Netherton Syndrome, on June 23, 2026, the FDA conditionally approved QYLEKI as the proposed brand name for QRX0031. QRX003 holds Orphan Drug Designation in the United States, the European Union, and Japan, along with Fast Track and Rare Pediatric Disease Designations from the FDA.1 The company also said on June 16, 2026, Quoin reported a positive clinical update from its ongoing Pediatric Compassionate Use Program.1 Separately, on June 30, 2026, the U.S. Patent and Trademark Office issued a Notice of Allowance for a patent application covering a method of treating Netherton Syndrome using a topical serine protease inhibitor together with an anti-inflammatory agent, including in patients carrying SPINK5 mutations.1
On the Peeling Skin Syndrome front, Quoin submitted its first-ever IND to the FDA on June 2, 2026, and the agency cleared the IND on July 9, 2026, subsequent to quarter end, expressing no safety concerns regarding study design or duration of dosing.1 The planned Phase 2/3 study, described as the first company-sponsored formal clinical study for the disease, is expected to enroll pediatric and adult patients in the United States and Europe and to initiate in the second half of 2026; there is currently no approved treatment for PSS.1
On the topical rapamycin platform, investigator-led studies are planned across several indications, including Pachyonychia Congenita, Gorlin Syndrome, and Tuberous Sclerosis Complex, and the company plans to submit an IND for an additional indication before the end of 2026.1
On financials, Quoin had approximately $10.8 million in cash, cash equivalents, and marketable securities as of June 30, 2026, which the company believes will fund operations into 2027.1 Net loss for the quarter was approximately $5.4 million, compared to approximately $3.7 million a year earlier.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.