Quoin Pharmaceuticals (QNRX) Company Report

Quoin Pharmaceuticals (QNRX) has submitted an application for Orphan Drug Designation (ODD) for its lead product candidate, QRX003, for the treatment of Netherton Syndrome to the Japanese MHLW.
The Japanese MHLW confirmed that QRX003 qualifies for both ODD and Fast Track regulatory review in Japan.
If granted, QRX003 will have ODD status in Quoin's three core commercial territories: the US, EU, and Japan, having previously received ODD from the U.S. FDA and EMA in 2025.
Quoin is initiating the establishment of a Japanese subsidiary to facilitate self-commercialization of QRX003 in Japan, if approved.
Enrollment in QRX003's pivotal clinical trials is expected to be completed in 1H 2026, with top-line data anticipated in 2H 2026, and NDA submission planned for late 2026 or early 2027.

Jan 27, 2026, 1:30 PM

Press Release

Quoin Pharmaceuticals Files for Breakthrough Medicine Designation in Saudi Arabia for QRX003

QNRX

Product Launch

New Projects/Investments

Quoin Pharmaceuticals Ltd. filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003, its lead investigational product candidate for Netherton Syndrome, on January 20, 2026.
If granted, QRX003 could be approved for sale and reimbursement in Saudi Arabia as early as the second half of 2026, potentially becoming the first ever approved treatment for Netherton Syndrome globally.
Enrollment in two late-stage clinical trials for QRX003 is expected to be completed in the first half of 2026, with top-line data anticipated in the second half of 2026.
Quoin plans to submit a New Drug Application (NDA) in the United States and other territories in late 2026/early 2027, subject to successful clinical outcomes.

Jan 20, 2026, 10:18 PM

8-K

Quoin Pharmaceuticals Files for Breakthrough Medicine Designation for QRX003 in Saudi Arabia

QNRX

New Projects/Investments

Product Launch

Quoin Pharmaceuticals (QNRX) has applied for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003, its lead product candidate for Netherton Syndrome.
If granted, this designation could enable accelerated regulatory review and potential market access in Saudi Arabia by 2H 2026, positioning QRX003 as the first global treatment for the disease.
Enrollment for QRX003's two late-stage clinical trials is expected to conclude in 1H 2026, with top-line data anticipated in 2H 2026.
A New Drug Application (NDA) submission in the U.S. and other regions is planned for late 2026/early 2027, contingent on successful clinical results.

Jan 20, 2026, 1:30 PM

Press Release

Quoin Pharmaceuticals Announces Q3 2025 Financial Results and Corporate Updates

QNRX

Earnings

CFO Change

New Projects/Investments

Quoin Pharmaceuticals reported a net loss of approximately $3.9 million for the three months ended September 30, 2025, and $11.5 million for the nine months ended September 30, 2025, primarily due to increased research and development expenditures.
As of September 30, 2025, the company had approximately $5.4 million in cash, cash equivalents, and marketable securities. In October 2025, a private placement financing closed with the potential to provide up to $105.3 million in capital, including $16.6 million in upfront funding and an additional $3.3 million from warrant exercises, which is expected to support operations into 2027.
Sally Lawlor was appointed Chief Financial Officer on August 18, 2025, to support the company's commercialization and financial operations.
The company announced that QRX003 pivotal studies for Netherton Syndrome are set to commence enrollment in Q4 2025, following the award of Orphan Drug Designation by the FDA for QRX003 for Netherton Syndrome.

Nov 6, 2025, 9:18 PM

8-K

Quoin Pharmaceuticals Announces Q3 2025 Financial Results and Corporate Update

QNRX

Earnings

CFO Change

New Projects/Investments

Quoin Pharmaceuticals reported a net loss of approximately $3.9 million for the third quarter ended September 30, 2025, with research and development expenditures increasing to $2.3 million.
As of September 30, 2025, the company had $5.4 million in cash, cash equivalents, and marketable securities, supplemented by $16.6 million in upfront funding from a private placement in October 2025 and $3.3 million from warrant exercises, which is expected to support operations into 2027.
Sally Lawlor was appointed Chief Financial Officer in August 2025 to support commercialization and financial operations.
The company's lead clinical asset, QRX003, received Orphan Drug Designation from the FDA for Netherton Syndrome, and pivotal studies are scheduled to commence enrollment in Q4 2025.

Nov 6, 2025, 1:30 PM

Press Release

Quoin Pharmaceuticals Announces Additional Patient Recruitment and Positive 9-Month Clinical Data for QRX003

QNRX

New Projects/Investments

Quoin Pharmaceuticals has recruited three additional pediatric patients in Austria and Ireland for its investigator-led Netherton Syndrome (NS) study.
The company reported highly positive 9-month clinical data from the first pediatric patient treated with QRX003 for Netherton Syndrome.
The first patient's skin is now completely healed, with the Investigator's Global Assessment (IGA) improving from 4 (Severe) to 0 (Clear), and pruritus (itch) reduced from 5 at baseline to 0.
No adverse events have been reported after 9 months of continuous daily dosing with QRX003, and the patient no longer requires previously necessary medications.

Oct 28, 2025, 12:30 PM

Press Release

Quoin Pharmaceuticals announces U.S. FDA Orphan Drug Designation for QRX003

QNRX

Product Launch

New Projects/Investments

Quoin Pharmaceuticals Ltd. (QNRX) received U.S. FDA Orphan Drug Designation for its lead product candidate, QRX003, for the treatment of Netherton Syndrome on October 21, 2025, following a similar designation from the European Medicines Agency (EMA) in May 2025.
This designation provides significant benefits, including seven years of market exclusivity if QRX003 is approved, along with tax credits for qualified clinical testing and waiver or partial payment of FDA application fees.
The company expects to complete enrollment in two pivotal clinical trials for QRX003 in Q1 2026, with top-line data anticipated in the second half of 2026, and a New Drug Application (NDA) submission planned later in 2026.

Oct 21, 2025, 8:40 PM

8-K

Quoin Pharmaceuticals Receives U.S. FDA Orphan Drug Designation for QRX003

QNRX

Product Launch

New Projects/Investments

Quoin Pharmaceuticals (QNRX) announced on October 21, 2025, that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to its lead product candidate, QRX003, for the treatment of Netherton Syndrome, following a similar designation from the European Medicines Agency (EMA) in May 2025.
The FDA's ODD provides significant benefits, including seven years of market exclusivity if QRX003 is approved.
Enrollment for QRX003's two late-stage pivotal clinical trials is expected to conclude in Q1 2026, with top-line data anticipated in the second half of 2026 and a New Drug Application (NDA) submission planned later that year.

Oct 21, 2025, 12:30 PM

Press Release

Quoin Pharmaceuticals Announces Private Placement Financing

QNRX

New Projects/Investments

Quoin Pharmaceuticals announced a private placement financing with the potential to raise up to $104.5 million in gross proceeds.
The financing includes $16.5 million in initial upfront funding and up to an additional $88.0 million upon the potential cash exercise of accompanying warrants.
The company will issue 1,993,940 American Depository Shares (ADSs) (or pre-funded warrants) and accompanying warrants to purchase up to 7,975,760 ADSs at a combined purchase price of $8.25 per ADS and accompanying warrants.
The proceeds are intended for general corporate purposes, including operating expenses, research and development for QRX003 for Netherton Syndrome, working capital, and future acquisitions.
The aggregate net proceeds, assuming full warrant exercise, are expected to fund the company into 2027.