AI Earnings Predictions for Quoin Pharmaceuticals Ltd. (QNRX)

EX-99.1

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EXHIBIT 99.1

Exhibit 99.1

Quoin Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2026 Financial Results

– Reports Positive Interim Data from Ongoing Phase 2/3 Study of QRX003 in Netherton Syndrome; Primary and Key Secondary Endpoints Achieved Statistical Significance Versus Pre-Specified Alpha-Adjusted Target

–Announces Private Placement Financing of Up to $50.0 Million with Healthcare-Focused Institutional Investors

– FDA Clears First-Ever IND for Peeling Skin Syndrome (PSS), Grants Rare Pediatric Disease and Fast Track Designations to QRX003 for PSS; EMA Grants Orphan Drug Designation to QRX003 for PSS Subsequent to Quarter End

– Advances QRX009 Topical Rapamycin Platform Toward Clinical Testing in a Number of Indications

– Expands NETHERTON NOW Awareness Campaign with New Video Featuring a Pediatric Critical Care Physician and Her Daughter

–Peer-Reviewed Paper on QRX003 for Netherton Syndrome Published in Dermatology and Therapy Subsequent to Quarter End

ASHBURN, Va., Nov. 05, 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 progress for the third quarter ended September 30, 2026.

“The third quarter substantially strengthened Quoin’s clinical, regulatory and financial foundation for long-term growth. Interim clinical results from our Phase 2/3 study of QRX003 in Netherton Syndrome demonstrated statistical significance for the primary and key secondary endpoints, representing what we believe is the first ever overall positive data set published for this disease. In addition, QRX003 was awarded Rare Pediatric Disease and Fast Track Designations in Peeling Skin Syndrome. Finally, our successful August private placement has provided us with funding to fully complete the development of QRX003 for Netherton Syndrome, whilst enabling us to selectively invest in the advancement of our pipeline products. We were pleased to see the participation of both new and existing investors in the raise,” said Dr. Michael Myers, Chief Executive Officer and Co-Founder of Quoin Pharmaceuticals. “Following quarter end, QRX003 was awarded EU Orphan Drug Designation in Peeling Skin Syndrome, and the publication of our paper in Dermatology and Therapy, on a pediatric case report, has added peer-reviewed clinical evidence to the growing body of data supporting QRX003 as a potentially safe and effective treatment for Netherton Syndrome.”

Dr. Myers added, “Our priorities for the coming months are very clear. We expect to complete recruitment in our Netherton Syndrome study by year end and report topline data in the second quarter of 2027. We also plan to initiate the first-ever formal clinical study in Peeling Skin Syndrome before year end whilst simultaneously advancing our QRX009 topical rapamycin program towards clinical testing in early 2027. These are indeed exciting times for Quoin as we continue to move closer towards achieving our goal of delivering the first approved treatment for Netherton Syndrome.”

QRX003 – Netherton Syndrome

Positive Interim Data from Phase 2/3 Study CL-QRX003-004. On August 28, 2026, Quoin reported positive interim results from CL-QRX003-004, its ongoing Phase 2/3 study of QRX003 4% lotion in patients with Netherton Syndrome. In the interim analysis of the first six participants to complete 12 weeks of treatment, four of six (66.7%) achieved the primary endpoint of a 1-grade or greater improvement in Investigator Global Assessment (p=0.0087 vs. a pre-specified alpha of 0.0215). The key secondary endpoint, a Global Statistical Test of Global Impression of Change, also achieved statistical significance at Week 12 (p=0.0070 vs. a pre-specified alpha of 0.0215). All three participants with moderate to severe pruritus at baseline achieved a 3-grade or greater improvement in the Worst Itch Numeric Rating Scale at Week 12, with one participant achieving a greater than 6-grade improvement. No treatment-related serious adverse events were reported. Quoin expects to complete recruitment of all 20 participants by the end of 2026 and to report topline data in the second quarter of 2027.

Corporate and Financing

Private Placement of Up to $50.0 Million. On August 28, 2026, Quoin announced a private placement with new and existing healthcare-focused institutional investors for up to approximately $50.0 million in gross proceeds, including initial upfront funding of approximately $30.8 million and up to an additional approximately $19.2 million upon the potential cash exercise of accompanying ordinary warrants.

QRX003 – Peeling Skin Syndrome

First-Ever IND for Peeling Skin Syndrome Cleared by FDA. On

July 9, 2026, Quoin announced that the FDA had cleared its IND for QRX003 in Peeling Skin Syndrome (PSS), the first IND ever submitted to the F

EX-99.1

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EXHIBIT 99.1

Exhibit 99.1

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.

On March 11, 2026, 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.

On March 25, 2026, Quoin provided a clinical and regulat