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Quoin Pharmaceuticals Ltd. (QNRX) reports news about a late clinical-stage specialty pharmaceutical company developing therapies for rare and orphan diseases. Updates center on QRX003 lotion for Netherton Syndrome and related rare skin disorders, including clinical-study progress and U.S. and European orphan, rare pediatric disease and fast track regulatory designations.
Company news also covers QRX009 topical rapamycin development programs, rare dermatologic and genetic disease research, quarterly financial results, private-placement financing and distribution or commercialization arrangements for potential international markets.
Quoin Pharmaceuticals (NASDAQ: QNRX) announced submission to Japan's MHLW for Orphan Drug Designation (ODD) for QRX003 in Netherton syndrome and said MHLW confirmed QRX003 qualifies for both ODD and Fast Track regulatory review in Japan.
The company plans to establish a Japanese subsidiary to support potential self-commercialization if approved. QRX003 already holds ODD in the US and EU (2025). QRX003 lotion (4%) is in two late‑stage pivotal whole‑body trials; enrollment is expected to finish in 1H 2026, top‑line data are anticipated in 2H 2026, and an NDA submission is planned in late 2026 or early 2027.
Quoin Pharmaceuticals (NASDAQ: QNRX) filed for Breakthrough Medicine Designation with the Saudi Food and Drug Authority for QRX003, its late‑stage topical candidate for Netherton Syndrome. If granted, the designation could enable accelerated review and potential sale and reimbursement in Saudi Arabia as early as 2H 2026. QRX003 holds U.S. Orphan and Pediatric Rare Disease designations and an EU Orphan designation. QRX003 lotion (4%) is in two pivotal whole‑body trials with enrollment expected to finish in 1H 2026 and top‑line data anticipated in 2H 2026. Quoin has a regional distribution partnership with Genpharm for Saudi Arabia and MENA.
Quoin Pharmaceuticals (NASDAQ: QNRX) announced it has achieved target topical rapamycin loadings of 4% w/w in a proprietary lotion and 5% w/w in a proprietary dermal patch.
The company plans manufacture of clinical trial and stability batches from at least one delivery technology in Q4 2025 and to commence clinical testing in multiple indications, including microcystic lymphatic malformations and venous malformations, in 1H 2026. Quoin noted no FDA‑approved treatments currently exist for those target indications.
The announcement also referenced ongoing pivotal Netherton Syndrome studies and a recently closed capital raise intended to fund near‑term programs including topical rapamycin.
Quoin Pharmaceuticals (NASDAQ: QNRX) provided a corporate update and Q3 2025 results on Nov 6, 2025. Key developments include a private placement financing up to $105.3M (including $16.6M upfront and up to $88.7M via warrant exercises), $3.3M received from warrant exercises, and a cash position of $5.4M as of Sept 30, 2025. The company said these funds are expected to support operations into 2027.
Clinical progress: QRX003 received FDA Orphan Drug designation for Netherton Syndrome, pivotal enrollment for QRX003 to begin in Q4 2025, and pediatric program expansion based on positive long‑term safety/efficacy data. Corporate moves include the appointment of Sally Lawlor as CFO. The NETHERTON NOW awareness campaign exceeded 1.5 million video views in six months.
Quoin Pharmaceuticals (NASDAQ: QNRX) announced an upcoming corporate update and release of third quarter 2025 financial results on Thursday, November 6, 2025.
The company said it will provide an operational update highlighting key achievements from the quarter, recent accomplishments, and financial highlights for the quarter ended September 30, 2025, with details scheduled to be released before the market opens on November 6, 2025.
Quoin Pharmaceuticals (NASDAQ: QNRX) announced recruitment of three additional pediatric patients in an investigator‑led Netherton syndrome study and reported positive 9‑month whole‑body data from the first pediatric subject.
The subject's Investigator's Global Assessment (IGA) improved from 4 (severe) at baseline to 0 (clear) at 9 months, and pruritus fell from 5 to 0. The subject reports zero nightly sleep disturbance, no need for prior medications (antibiotics, antivirals, antihistamines, glucocorticoids), and no adverse events after 9 months of continuous daily QRX003 whole‑body dosing. Two new pediatric subjects are in Austria and one is in Ireland; all will receive twice‑daily whole‑body QRX003 with a 12‑week initial period followed by a long‑term extension.
Quoin Pharmaceuticals (NASDAQ: QNRX) announced the U.S. FDA has granted Orphan Drug Designation for QRX003 to treat Netherton Syndrome on Oct 21, 2025.
The FDA designation follows an EMA orphan designation in May 2025 and provides benefits including tax credits, fee waivers or reductions, and seven years of US market exclusivity if QRX003 is approved. QRX003 lotion (4%) is in two late‑stage pivotal whole‑body trials; enrollment is expected complete in Q1 2026, topline data is anticipated in H2 2026, and an NDA submission is planned later in 2026.
Quoin Pharmaceuticals (NASDAQ: QNRX) entered a private placement to raise up to $104.5 million in gross proceeds, including $16.5 million upfront and up to $88.0 million from cash exercise of accompanying warrants. The placement priced at $8.25 per ADS and includes 1,993,940 ADSs (or pre-funded warrants) and warrants to purchase up to 7,975,760 ADSs across four warrant series (H, I, J, K) with exercise prices from $9.075 to $12.375.
Participating healthcare investors include AIGH Capital, Soleus Capital, Nantahala Capital, Diadema Partners, Stonepine, ADAR1 Capital, and Velan Capital; Maxim Group is sole placement agent. Closing is expected on or about October 14, 2025. Proceeds are earmarked for R&D including completion of QRX003 pivotal development, operating expenses, and general corporate purposes; net proceeds are expected to fund the company into 2027.
Quoin Pharmaceuticals (NASDAQ: QNRX) has released the fifth episode of its NETHERTON NOW video series, featuring twin sisters Allie and Kaleigh Fasanella, both living with Netherton Syndrome. The episode highlights the physical, emotional, and social challenges of living with this rare genetic skin disease.
The sisters, who are successful freelance writers for major publications like Allure and Teen Vogue, share their experiences with unpredictable flare-ups, constant pain, and mental health challenges since being diagnosed in their first year of life. The video release coincides with Quoin's advancement of QRX003, their lead product candidate for Netherton Syndrome, currently in pivotal clinical trials with encouraging early data.
Quoin Pharmaceuticals (NASDAQ: QNRX) announced that its NETHERTON NOW awareness campaign has achieved significant milestones, surpassing 1 million video views and 14 million impressions. The campaign, focused on raising awareness about Netherton Syndrome (NS), a rare genetic skin disease, has gained widespread exposure through major media outlets including MSN, Today, and CBS News.
The company's lead candidate, QRX003, is currently in late-stage clinical trials for treating Netherton Syndrome. The studies are evaluating the treatment both as monotherapy and in combination with off-label systemic treatments. Full enrollment for these trials is expected in early to mid-Q1 2026.