CORRECTION -- Quoin Pharmaceuticals Provides Clinical and Regulatory Update for QRX009 Topical Rapamycin Development Programs

Quoin Pharmaceuticals (NASDAQ: QNRX) provided a clinical and regulatory update for its QRX009 topical rapamycin programs on April 28, 2026.

Rhea-AI Summary

Quoin Pharmaceuticals (NASDAQ: QNRX) provided a clinical and regulatory update for its QRX009 topical rapamycin programs on April 28, 2026. The company plans multiple investigator-led studies: a Pachyonychia Congenita (PC) trial led by Professor Edel O’Toole, plus Gorlin Syndrome (GS) and Tuberous Sclerosis Complex (TSC) studies.

Quoin reported achieving target loading concentrations of 4% and 5% for its lotion and dermal patch, and is targeting an IND submission to the FDA in Q3 2026 for an additional indication. The company expects potential active testing in up to four indications before end of 2026 and is also advancing QRX003 toward pivotal trials for Netherton Syndrome.

Positive

• Investigator-led PC trial to be led by Professor Edel O’Toole
• IND submission targeted Q3 2026 for an additional QRX009 indication
• Achieved 4% and 5% loading concentrations for lotion and dermal patch
• Potential for active testing in four indications before end of 2026

Negative

• None.

Argus Apr 28 session

-0.18% close to close Open Argus

Details

News Market Reaction – QNRX

On Apr 28, the day this news came out, QNRX closed 0.18% below the previous close.

Data tracked by StockTitan Argus for the Apr 28 session.

Key Figures

QRX009 loading concentrations: 4% and 5% Planned PC study start: Q3 2026 Additional IND timing: Q3 2026 +5 more

QRX009 loading concentrations

4% and 5%

Target loading concentrations for lotion and dermal patch systems

Planned PC study start

Q3 2026

Target timing to initiate Pachyonychia Congenita investigator-led study

Additional IND timing

Q3 2026

Planned IND submission for QRX009 for an additional indication

Potential active indications

Four indications

Company statement on QRX009 testing scope before end of 2026

NS program stage

Pivotal trials

QRX003 advancing to pivotal trials for Netherton Syndrome

Peeling Skin Syndrome IND

Q3 2026

Target for QRX003-related IND in Peeling Skin Syndrome

Pre-news share price

$5.46

Close before QRX009 update; near 52-week low of $5.32

Pre-news move

-4.21%

24h change into the announcement

Historical Context

5 past events · Latest: Mar 26

5 events

1. Mar 26

   Earnings and financing

   24h Move

   -18.4%

   Full-year 2025 results, private placement up to $104.5M, cash runway into 2027.

2. Mar 25

   FDA meeting update

   24h Move

   +15.9%

   Constructive FDA Type C meeting; single Phase 3 may support approval.

3. Mar 19

   Earnings date notice

   24h Move

   +5.4%

   Announcement of timing for Q4 and full-year 2025 results and update.

4. Mar 11

   Fast Track designation

   24h Move

   -1.1%

   FDA Fast Track for QRX003 for Netherton Syndrome, a rare severe disease.

5. Feb 26

   Awareness campaign

   24h Move

   +0.1%

   NETHERTON NOW awareness campaign milestones and late-stage QRX003 positioning.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

topical rapamycin, pachyonychia congenita, gorlin syndrome, tuberous sclerosis complex, +3 more

7 terms

topical rapamycin medical

"clinical and regulatory update for its QRX009 topical rapamycin development programs."

Topical rapamycin is the skin-applied form of rapamycin, a drug that dials down a cellular growth pathway so skin cells are less prone to overgrow or become inflamed; think of it like a dimmer switch that calms runaway cell activity at the surface. For investors, its importance lies in clinical uses and cosmetic demand—successful safety data, regulatory approvals, or clear benefits for conditions like certain skin lesions or signs of aging can create new product markets or change the prospects for companies developing or supplying it.

pachyonychia congenita medical

"The first study will be in, Pachyonychia Congenita (PC), a rare skin disease..."

A rare inherited skin disorder that causes thick, discolored nails, painful blisters or calluses on the feet and hands, and sometimes other skin problems due to mutations in certain structural proteins. For investors, it matters because companies working on treatments face a small but clearly defined patient population, opportunities for orphan-drug designation, and trial and regulatory readouts that can sharply change a developer’s valuation—think of it as a niche market where successful clinical results can have outsized financial impact.

gorlin syndrome medical

"Quoin is planning to initiate investigator-led clinical studies in both Gorlin Syndrome (GS)..."

A rare inherited genetic condition that increases a person’s lifetime risk of developing multiple skin cancers and other growths, often beginning in childhood or early adulthood. For investors it matters because the small, defined patient group and predictable medical needs make the condition a target for specialized drugs, diagnostics and long‑term care markets; think of it like a known design flaw that creates steady demand for fixes and monitoring.

tuberous sclerosis complex medical

"clinical studies in both Gorlin Syndrome (GS) and Tuberous Sclerosis Complex (TSC) later this year."

Tuberous sclerosis complex is a genetic disorder that causes noncancerous growths to form in multiple organs such as the brain, kidneys, heart and lungs, often leading to seizures, developmental delays and organ problems. Investors watch it because treatments, diagnostics and devices targeting this condition can drive clinical trial activity, regulatory decisions and long-term healthcare costs; think of it like a design flaw in a building blueprint that creates many small structural issues needing medical solutions and funding.

investigational new drug application regulatory

"targeting to file Investigational New Drug Application to US Food and Drug Administration..."

An investigational new drug application is a formal request made to regulatory authorities to begin testing a new medication in humans. It is a critical step in the drug development process, as approval indicates the drug has passed initial safety checks and can be studied further. For investors, this signals that a potential new treatment is progressing through its early testing stages, which can impact the company's future growth prospects.

orphan diseases medical

"late clinical stage specialty pharmaceutical company focused on rare and orphan diseases..."

Orphan diseases are rare medical conditions that affect a small number of patients compared with common illnesses. For investors, they matter because treatments for these conditions often receive special regulatory incentives—like tax credits, faster review, and market exclusivity—so a successful therapy can win a protected, premium-priced niche market much like a specialized product that serves few customers but commands high margins.

netherton syndrome medical

"ongoing late-stage program in Netherton Syndrome (NS) as well as our program in Peeling Skin Syndrome..."

A rare inherited skin and immune disorder that causes fragile, scaly, inflamed skin, frequent infections, and fragile or unusual hair, like a house with faulty waterproofing that lets problems in. For investors, it matters because the small patient population, severe unmet medical need, and predictable biological cause can make treatments eligible for special regulatory incentives, faster development paths, and premium pricing if a safe, effective therapy is approved.

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Company Planning Multi-Pronged Approach for QRX009 Including Several Investigator Led Clinical Studies in Key Indications.

Company to Initiate Investigator Led Clinical Study in Pachyonychia Congenita

Study Will be Led By Professor Edel O’Toole, Queen Mary University of London, Globally Recognized Leader in Pachyonychia Congenita

Quoin Also Planning to Initiate Investigator Led Studies in Gorlin Syndrome and Tuberous Sclerosis Complex

In addition to the Investigator Led Studies Company is Targeting to File Investigational New Drug Application to US Food and Drug Administration for QRX009 for an additional indication in Q3 2026

Quoin has Established Relationships With Key Advocacy Foundations including The PC Project and The Gorlin Syndrome Alliance as well as with Leading KOLs and Clinicians

ASHBURN, Va., April 28, 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 provided a clinical and regulatory update for its QRX009 topical rapamycin development programs. The Company is planning to initiate several investigator-led clinical studies for its QRX009 topical rapamycin lotion in a number of key target indications. The first study will be in, Pachyonychia Congenita (PC), a rare skin disease with no approved treatments or cure. This study will be led by Professor Edel O’Toole of Queen Mary University of London, a globally recognized clinician and thought-leader in PC who has previous experience in clinical trials for PC. Quoin believes that Professor O’Toole’s expertise coupled with the Company’s proprietary delivery technology could lead to improved clinical outcomes for PC patients over past studies. The Company is targeting initiating this study in Q3 of this year. In addition, Quoin is planning to initiate investigator-led clinical studies in both Gorlin Syndrome (GS) and Tuberous Sclerosis Complex (TSC) later this year. Finally, Quoin is on track to submit an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for QRX009 for an additional indication in Q3 of this year.

Dr. Michael Myers, Chief Executive Officer of Quoin commented, “We are very pleased to provide this important update for our QRX009 topical rapamycin programs. Since we announced that we had achieved our target loading concentrations of 4% and 5% for our proprietary lotion and dermal patch delivery systems, we have been working diligently to advance our products into the clinic. We are delighted that Professor O’Toole has agreed to lead an investigator study in PC, a disease in which she has renowned expertise and deep clinical experience. In addition, we are pleased to have the opportunity to initiate investigator-led clinical studies in GS and TSC. On the regulatory front, we are on track to submit our first IND to the FDA for QRX009 in Q3 of this year for a separate indication and the potential exists for QRX009 to be in active testing in four separate clinical indications before the end of 2026. We view these opportunities as highly complementary to our ongoing late-stage program in Netherton Syndrome (NS) as well as our program in Peeling Skin Syndrome, for which we are also targeting an IND application in Q3, 2026. This is a very exciting time for Quoin as we continue our mission of targeting rare skin diseases for which there are no or limited approved treatments. 2026 is shaping up to be a transformational year for our Company not only as we advance to pivotal trials for QRX003 for the treatment of NS, but also as we move forward across these multiple fronts.”

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 updates.

Cautionary Note Regarding Forward Looking Statements

The 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,” 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 plans to initiate several investigator-led clinical studies for its QRX009 topical rapamycin lotion in a number of key target indications; the Company initiating investigator-led study in Pachyonychia Congenita; Professor O’Toole’s expertise coupled with the Company’s proprietary delivery technology leading to improved clinical outcomes for PC patients over past studies; initiating the study for QRX009 in Q3 of this year; plans to initiate investigator-led clinical studies in GS and TSC later this year; being on track to submit an IND to the FDA for QRX009 in Q3 of this year; working diligently to advance the Company’s products into the clinic; the potential for QRX009 to be in active testing in four separate clinical indications before the end of 2026; targeting an IND application for Peeling Skin Syndrome in Q2 2026; targeting rare skin diseases for which there are no or limited approved treatments; 2026 shaping up to be a transformational year for the Company as it advances to pivotal trials for QRX003 for the treatment of NS and moves forward across multiple fronts; and Quoin’s products in development collectively having 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. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company’s ability to pursue its regulatory strategy; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company’s ability to complete clinical trials on time and achieve desired results and benefits as expected; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

For further information, contact:

Quoin Pharmaceuticals Ltd.    
Dr. Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com

Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Quoin announcing about QRX009 clinical studies for Pachyonychia Congenita (QNRX)?

Quoin announced an investigator-led PC study to be led by Professor Edel O’Toole. According to the company, the study is planned to start in Q3 2026 and will test QRX009 topical rapamycin in PC patients using the company’s delivery technology.

When is Quoin targeting to submit an IND to the FDA for QRX009 (QNRX)?

Quoin is targeting to submit an Investigational New Drug application in Q3 2026. According to the company, this IND would cover an additional indication for QRX009 and advance regulatory steps toward clinical testing in the U.S.

Which other indications will Quoin pursue with investigator-led QRX009 studies (QNRX)?

Quoin plans investigator-led studies in Gorlin Syndrome and Tuberous Sclerosis Complex later in 2026. According to the company, these studies are planned in addition to the Pachyonychia Congenita trial and align with its rare-skin-disease focus.

What formulation milestones did Quoin report for QRX009 (QNRX)?

Quoin reported achieving target loading concentrations of 4% and 5% for its lotion and dermal patch. According to the company, these formulation milestones support advancing QRX009 into multiple clinical studies.

How does QRX009 development relate to Quoin’s other programs like QRX003 and Peeling Skin Syndrome (QNRX)?

Quoin expects QRX009 studies to complement its late-stage QRX003 program for Netherton Syndrome. According to the company, it is also targeting an IND for Peeling Skin Syndrome in Q3 2026, indicating a multi-program clinical year.