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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) reported Q1 2026 updates and progress for QRX003 and QRX009. Key regulatory milestones include U.S. FDA Fast Track for QRX003, FDA feedback that a single Phase 3 may suffice, MHLW confirmation of Orphan Drug Designation and Fast Track in Japan, and an SFDA Breakthrough filing.
The company expects Phase 3 recruitment complete by end of 2026, potential NDA filing in 2027, topline Phase 3 data in H2 2026, and held ~$14 million cash at March 31, 2026.
Quoin Pharmaceuticals (NASDAQ: QNRX) will provide a corporate update and release first quarter 2026 financial results before the market opens on Thursday, May 7, 2026.
The company said the announcement will include an operational update highlighting key quarterly achievements, recent accomplishments, and financial highlights for the quarter ended March 31, 2026.
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: a Pachyonychia Congenita (PC) trial led by Professor Edel O’Toole, plus Gorlin Syndrome (GS) and Tuberous Sclerosis Complex (TSC) studies.
Quoin reported achieving target loading concentrations of 4% and 5% for its lotion and dermal patch, and is targeting an IND submission to the FDA in Q3 2026 for an additional indication. The company expects potential active testing in up to four indications before end of 2026 and is also advancing QRX003 toward pivotal trials for Netherton Syndrome.
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.