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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) provided a clinical and regulatory update for its QRX009 topical rapamycin programs on April 28, 2026. The company plans multiple investigator-led studies, starting with Pachyonychia Congenita led by Professor Edel O’Toole, plus planned studies in Gorlin Syndrome and Tuberous Sclerosis Complex.
Quoin expects to file an IND with the FDA for an additional QRX009 indication in Q3 2026 and aims to have QRX009 in active testing across multiple indications before end of 2026.
Quoin Pharmaceuticals (NASDAQ: QNRX) reported Q4 and full-year 2025 updates, including a closed private placement of up to $104.5 million, orphan and Fast Track designations for QRX003, expanded pediatric Netherton Syndrome cohorts to seven patients, and continued clinical progress with planned Phase 3 start and topline data in 2H 2026. Year-end cash was $18.7 million, which the company expects will fund operations into 2027.
Quoin Pharmaceuticals (NASDAQ: QNRX) reported a constructive Type C meeting with the U.S. FDA on March 25, 2026 regarding QRX003 for Netherton Syndrome. FDA indicated a single Phase 3 may suffice and showed openness to alternative designs without traditional upfront placebo or vehicle control.
Quoin plans to submit Phase 2 and pediatric data, initiate a pivotal Phase 3, complete recruitment by end of 2026, and potentially file an NDA in 2027.
Quoin Pharmaceuticals (NASDAQ: QNRX) will provide a corporate update and release fourth quarter and full-year 2025 financial results before the market opens on Thursday, March 26, 2026.
The announcement will include an operational update highlighting key achievements from the quarter, recent accomplishments, and financial highlights from 2025, per the company.
Quoin Pharmaceuticals (NASDAQ: QNRX) announced the FDA granted Fast Track Designation to QRX003 lotion (4%) for treatment of Netherton Syndrome on March 11, 2026. QRX003 is in two late-stage whole-body clinical trials and previously received Orphan Drug and Pediatric Rare Disease designations from FDA and EMA.
The Fast Track status enables more frequent FDA interactions and potential accelerated review pathways that may speed development toward a first approved therapy for this rare disorder.
Quoin Pharmaceuticals (NASDAQ: QNRX) marked Rare Disease Day 2026 by highlighting its NETHERTON NOW awareness campaign, launched in Rare Disease Month 2025 to raise visibility for Netherton Syndrome, a rare genetic skin disorder with no approved treatment. The campaign has generated nearly 2 million video views and over 24 million impressions. Quoin said its lead candidate, QRX003, is in late-stage pivotal clinical trials as the company seeks regulatory pathways and broader access for potential treatments.
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.