Full Press Release Details
Quoin Pharmaceuticals Provides Corporate Update and Reports First
Quarter 2026 Financial Results
- Filed Breakthrough Medicine Designation Application with
Saudi FDA for QRX003 in Netherton Syndrome
- Submitted Application to Japanese MHLW for Orphan Drug Designation
(ODD) for QRX003; MHLW Confirmed QRX003 Qualifies for Both Orphan Drug Designation and Fast Track Review
- U.S. FDA Granted Fast Track Designation to QRX003 lotion
(4%) for the treatment of Netherton Syndrome, Complementing Previously Granted Orphan Drug and Rare Pediatric Disease Designations
- Constructive Type C Meeting with FDA: Single Phase 3 Study
May Be Sufficient to Support U.S. Marketing Approval; FDA Open to Trial Design Without Traditional Vehicle or Placebo Control
- Rare Pediatric Disease Priority Review Voucher Program Extended
by Congress Through September 30, 2029
- On Track to Complete Phase 3 Patient Recruitment by End
of 2026, with Potential NDA Filing in 2027 for QRX003 as the First Approved Treatment for Netherton Syndrome
ASHBURN, Va., May 7, 2026 (GLOBE NEWSWIRE) - Quoin Pharmaceuticals
Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage specialty pharmaceutical company focused on
rare and orphan diseases, today announced recent corporate achievements and provided an update on its first quarter 2026 progress for
the period ended March 31, 2026.
"The first quarter of 2026 delivered meaningful regulatory progress
on a number of fronts for QRX003 for Netherton Syndrome," said Dr. Michael Myers, Chief Executive Officer and Co-Founder of
Quoin Pharmaceuticals. "In the United States, we were granted Fast Track Designation by the U.S. Food and Drug Administration (FDA).
In addition, we had a constructive Type C meeting with FDA where the agency indicated that a single Phase 3 study may be sufficient to
support marketing approval, with expressed openness to an alternative study design for Phase 3 that would likely not include a traditional
upfront vehicle or placebo control. In Japan, we submitted our Orphan Drug Designation application following confirmation from MHLW that
QRX003 qualifies for both ODD and Fast Track review. In Saudi Arabia, we filed for Breakthrough Medicine Designation, which could expedite
the path to patient access, if granted. We also remain on track to complete Phase 3 recruitment this year and potentially file for NDA
approval in 2027. On top of this, we have made substantial progress this year with our QRX009 topical rapamycin platform. Through engagement
with KOLs and advocacy foundations, we are now in a position to initiate clinical testing in a number of indications later this year including
investigator studies for Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex. We are also planning to submit an Investigational
New Drug (IND) Application to the FDA for QRX009 for an additional indication by Q3 of this year. We believe the combination of our QRX003
platform for Netherton Syndrome and related diseases combined with our QRX009 topical rapamycin platform represents an intriguing value
proposition for investors and we look forward to sharing more information on both throughout this year."
First Quarter 2026 Highlights
Regulatory Progress for QRX003 in Netherton Syndrome:
On January 20, 2026,
Quoin filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003. If granted,
the designation could enable accelerated regulatory review and availability in Saudi Arabia. Quoin has an established distribution partnership
with Genpharm for QRX003 in Saudi Arabia and other MENA countries.
On January 27, 2026,
Quoin submitted an application to Japan's Ministry of Health, Labour and Welfare (MHLW) seeking Orphan Drug Designation for QRX003. MHLW
confirmed that QRX003 qualifies for both Orphan Drug Designation and Fast Track review in Japan. The Company has also initiated the establishment
of a Japanese subsidiary to facilitate self-commercialization of QRX003 in Japan, if approved.
On February 3, 2026,
the U.S. Rare Pediatric Disease Priority Review Voucher (PRV) program was extended by Congress through September 30, 2029 as part
of the Give Kids a Chance Reauthorization Act. QRX003 previously received Rare Pediatric Disease Designation from the FDA in June 2025.
Upon approval of QRX003, Quoin would be eligible to receive a Priority Review Voucher, which if awarded may be used to obtain priority
review for another product or sold or transferred.
the U.S. FDA granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome. Fast Track status enables
more frequent interactions with the FDA, eligibility for rolling review of regulatory submissions, and potential qualification for Accelerated
Approval and Priority Review, if relevant criteria are met.
Quoin provided a clinical and regulatory update from its constructive Type C meeting with the FDA for QRX003 in Netherton Syndrome. The
FDA indicated that a single Phase 3 study may be sufficient to support marketing approval in the U.S. and expressed openness to an alternative
study design, such as a randomized withdrawal or randomized delayed start, that would likely not include a traditional upfront vehicle
or placebo control. Quoin will submit clinical data from the ongoing Phase 2 and pediatric investigator studies and plans to request
a meeting to discuss this data with the FDA prior to initiating the Phase 3 pivotal program to gain alignment on the design of the program.
Quoin remains on track to complete patient recruitment into its Phase 3 program by the end of 2026 and to potentially file for FDA approval
for QRX003 as the first treatment for Netherton Syndrome in 2027.
Quoin provided a clinical and regulatory update for its QRX009 topical rapamycin development program, announcing the planned initiation
of an investigator-led clinical study in Pachyonychia Congenita led by Professor Edel O'Toole, Queen Mary University of London
as well as additional investigator-led studies in Gorlin Syndrome and Tuberous Sclerosis Complex. In addition, Quoin is targeting to
submit an IND to the FDA for QRX009 for an additional indication in Q3 of 2026.
Clinical Development:
QRX003 lotion (4%) continues to be evaluated in late-stage whole-body
clinical trials for the treatment of Netherton Syndrome, with topline data anticipated in the second half of 2026. 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.
Additional QRX003 Indications: Quoin continues to advance its Peeling
Skin Syndrome (PSS) program, with the ongoing investigator-led study being expanded to six subjects. The Company plans to submit an IND
to the FDA for PSS in Q2 of 2026.
QRX009 Development: Quoin also continues to advance its proprietary
topical rapamycin platforms, which have achieved target loadings of 4% and 5% for the topical lotion and dermal patch, respectively. Investigator-led
clinical studies are being planned for a number of indications including Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis
Complex and the Company is planning to submit an IND to the FDA for QRX009 for an additional indication before the end of Q3 of this year.
Awareness and Advocacy:
On February 26, 2026,
in recognition of Rare Disease Day 2026, Quoin highlighted continued momentum of its NETHERTON NOW awareness campaign, which has reached
nearly 2 million video views and more than 24 million impressions globally since launch.
Financial Highlights
Quoin had approximately $14 million in cash, cash equivalents and marketable
securities as of March 31, 2026. The Company believes its current cash position will fund operations into 2027.
Net loss for the quarter ended March 31, 2026, was approximately
$5 million compared to approximately $3.8 million for the quarter ended March 31, 2025.
Investors are encouraged to read the Company's Quarterly Report on
Form 10-Q when filed with the Securities and Exchange Commission, which will contain additional details about Quoin's financial results
as of and for the period ended March 31, 2026.
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a late
clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan
diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin's
innovative pipeline is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad
number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, PC, GS, TSC, microcystic
lymphatic malformations, venous malformations, angiofibromas and others. For more information, visit: www.quoinpharma.com or LinkedIn for
Cautionary Note Regarding Forward Looking Statements
Company cautions that statements in this press release that are not a description of historical facts are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words
referencing future events or circumstances such as "expect," "intend," "plan," "anticipate,"
"believe," "look forward to," and "will," among others. All statements that reflect the Company's
expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking
statements, including, without limitation, statements relating to: a single Phase 3 study being sufficient to support US marketing approval
of QRX003 for Netherton Syndrome; the FDA being open to a trial design that would likely not include a traditional upfront vehicle or