Quoin Pharmaceuticals (NASDAQ:QNRX) said it received encouraging regulatory feedback from the U.S. Food and Drug Administration (FDA) following a Type C meeting held on March 25, 2026 regarding the development of QRX003, its investigational treatment for Netherton syndrome, a rare genetic skin disorder.
According to the company, the FDA indicated that a single Phase 3 trial could be sufficient to support a future marketing application for QRX003, rather than the two Phase 3 studies the company had previously considered necessary. Regulators also signaled openness to alternative clinical trial designs, including approaches that may not require a traditional placebo or vehicle-controlled study at the outset.
Based on the feedback, Quoin said it plans to submit data from its ongoing Phase 2 and pediatric investigator-led studies, while preparing to launch a pivotal Phase 3 program. The company aims to complete patient recruitment by the end of 2026 and could potentially file a New Drug Application (NDA) in 2027.
“We are very pleased to provide this update from our recent Type C meeting with FDA. Importantly, FDA acknowledged that a single Phase 3 study may be sufficient to support U.S. marketing approval of QRX003 for Netherton Syndrome, rather than the two Phase 3 studies the Company had originally contemplated. With our established network of U.S. and EU clinical trial sites, we are confident that we will be in a position to initiate our pivotal Phase 3 program and fully complete recruitment this year. FDA also expressed openness to an alternative, innovative clinical trial design, such as a randomized withdrawal or randomized delayed start study, which may be more appropriate Phase 3 design in the setting of Netherton Syndrome than a traditional upfront randomized, controlled study. Overall, this meeting represents an important milestone for Quoin and the Netherton Syndrome community at large. We are now in a position to move forward with clarity, and we remain on track to advance development of QRX003 with the goal of potentially delivering the first approved medication for the treatment of Netherton Syndrome. Finally, I would like to sincerely thank each of the KOLs who participated in the meeting: Professor Alan Irvine, Dr. Amy Paller, Dr. Keith Choate, Professor Jemima Mellerio, Professor Anna Martinez, Professor James Halpern and Professor Suzanne Pasmans. We are truly grateful for your continued support and expert input.” said Dr. Michael Myers, CEO of Quoin Pharmaceuticals.
Key outcomes from the FDA meeting
The company highlighted two main takeaways from its discussions with regulators:
The FDA suggested that a single Phase 3 clinical study may be adequate to support U.S. marketing approval of QRX003 for Netherton syndrome.
Regulators showed openness to alternative trial designs, such as randomized withdrawal or randomized delayed-start studies, which may better suit research in rare diseases and may not require a traditional placebo or vehicle-controlled design at the start.
Following the meeting, Quoin said it is implementing the FDA’s recommendations to prepare for the next stage of development. The company plans to request another regulatory meeting to review the Phase 2 and pediatric data before formally initiating the Phase 3 program.
If the development timeline proceeds as planned, Quoin expects to complete enrollment in the Phase 3 study by the end of 2026, potentially enabling the company to seek FDA approval for QRX003 in 2027. The therapy could become the first approved treatment specifically for Netherton syndrome.
About Quoin Pharmaceuticals
Quoin Pharmaceuticals Ltd. is a late-stage clinical specialty pharmaceutical company focused on developing treatments for rare and orphan diseases. The company’s pipeline includes therapies targeting conditions such as Netherton syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma, and other rare disorders.
Quoin said its goal is to address significant unmet medical needs faced by patients with rare diseases, along with their families and healthcare providers.