By M. Marin
NASDAQ: QNRX
READ THE FULL QNRX RESEARCH REPORT
Targeting completing recruitment for Phase 3 trial by YE26, potentially filing NDA in 2027 for QRX003 as 1st approved treatment for NS
Quoin Pharmaceuticals (NASDAQ: QNRX) is a late clinical-stage, specialty pharmaceutical company focused on developing treatments for rare and orphan diseases. QNRX reported 1Q26 results last week and provided a business update. The company is advancing lead asset QRX003, as well as pipeline assets, and has made strong advances in recent months. Reflecting these steps, discussed below, and positive data from clinical activities, QNRX reiterated its view that it is on track to complete recruitment for its Phase 3 Netherton Syndrome trial by year-end 2026 and potentially file a New Drug Application (NDA) in 2027 for QRX003 as the first approved treatment for Netherton Syndrome (NS). QNRX believes the global NS commercial opportunity could exceed $1 billion.
Quoin is currently conducting two pivotal clinical studies for QRX003 in NS that have generated positive data thus far. Specifically, clinical data to-date has demonstrated clear evidence of rapid, prolonged, and almost complete skin healing following twice-daily application of QRX003 to the treatment areas, along with the almost complete elimination of key symptoms such as chronic, debilitating pruritus, and has facilitated zero nightly sleep disturbances. Quoin expects to report topline data in 2H 2026.
People suffering from NS do not have as many layers of outer skin as they need, which means that their skin does not perform its primary function as a protective barrier. In turn, this increases the risk of infections, warts, irritation, and even skin cancer in some patients. Moreover, their skin tends to be prone to scaling and is accompanied by hair anomalies, along with increased susceptibility to atopic eczema and itching.
QRX003: being evaluated for NS, pediatric NS, and Peeling Skin Syndrome (PSS)
In addition to treatment of NS, QRX003 is also being evaluated for pediatric NS and Peeling Skin Syndrome (PSS). For example, Quoin is also conducting an investigator-led NS study in pediatric patients and recently recruited additional patients for twice-daily whole-body application of QRX003, initially for a period of twelve weeks before continuing in a long-term extension protocol until/if regulatory approval is granted. The ongoing pediatric investigator-led study has been expanded to six children actively being treated with QRX003 in Ireland, Austria, the Netherlands, and New Zealand, representing the largest pediatric cohort of this age group ever studied in Netherton Syndrome.
Quoin continues to advance its Peeling Skin Syndrome (PSS) evaluation of QRX003, with the ongoing investigator-led study having expanded to six subjects. The company plans to submit an IND to the FDA for PSS in 2Q26. Based on positive initial clinical data from the PSS study, QNRX is optimistic about the prospects of QRX003 for PSS. Currently, there are no approved treatments or cures for peeling skin syndrome. Quoin believes it has the potential to obtain the first regulatory approval for the disease.
Also advancing Rapamycin platform
In addition, Quoin has also advanced its QRX009 topical rapamycin platform this year. The company has engaged with KOLs and advocacy foundations and believes it is positioned to initiate clinical testing in multiple indications later in 2026, including investigator studies for Pachyonychia Congenita, Gorlin Syndrome, and Tuberous Sclerosis Complex.
The first study will be in Pachyonychia Congenita (PC), a rare skin disease with no approved treatments or cure. PC patients often deal with multiple issues, including painful calluses on the bottoms of their feet that can make it painful to walk. QNRX targets initiating this study in 3Q26.
Quoin is also planning to initiate investigator-led clinical studies in both Gorlin Syndrome (GS) and Tuberous Sclerosis Complex (TSC) later this year. QNRX intends to submit an Investigational New Drug (IND) application to the FDA for QRX009 for an additional indication by 3Q26.
Worldwide sales network to prepare for commercializing QRX003, other assets
The company is optimistic about the commercial prospects for its QRX003 platform for NS and other diseases and QRX009 topical rapamycin platform. With multiple regulatory designations that provide economic and potentially timeline benefits in place and others under review, Quoin has prepared for the expected commercial launch of QRX003 and potentially other pipeline assets designed to treat multiple dermatological indications by establishing a worldwide sales infrastructure that consists of proprietary network for core markets - the U.S., E.U, and Japan - and distribution partnerships that cover other global markets.
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