Latest news with #Quoin
Yahoo
22-05-2025
- Business
- Yahoo
Quoin Pharmaceuticals Announces FDA Clearance to Initiate Second Pivotal Whole Body QRX003 Netherton Syndrome Clinical Study
Study CL-QRX003-002 will test whole-body application of QRX003 in conjunction with off-label systemic therapy in approximately 12-15 subjects. Study CL-QRX003-002 complements first whole-body pivotal study, CL-QRX003-003, being led by Dr. Amy Paller at Northwestern University and supported by up to six international sites that are expected to open, where subjects are being tested with QRX003 as monotherapy. Combined data from Studies CL-QRX003-002 and CL-QRX003-003 is anticipated to provide QRX003 with the broadest possible label opportunity post-approval as both monotherapy and adjunct therapy in conjunction with off-label systemic treatments. Five U.S. clinical sites have been opened, and six international sites are being opened. All currently have available cohorts of subjects ready to be enrolled into the studies facilitating accelerated recruitment. Quoin anticipates completion of recruitment into both pivotal studies by end of Q1 2026 and filing an NDA for regulatory approval later in the year. ASHBURN, Va., May 22, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the 'Company' or 'Quoin'), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces FDA clearance to initiate a second Netherton Syndrome (NS) pivotal clinical study CL-QRX003-002 for QRX003. Quoin's lead product, QRX003, is a topical lotion formulated with a broad-spectrum serine protease inhibitor that has been shown to significantly downregulate the hyperactivity of the kallikreins in the skin responsible for the excessive skin shedding associated with this disease. Clinical data from Quoin's ongoing studies has demonstrated clear evidence of rapid, prolonged and almost complete skin healing following twice-daily application of QRX003 to the treatment areas along with the almost complete elimination of key symptoms such as chronic, debilitating pruritus and has facilitated zero nightly sleep disturbances. Study CL-QRX003-002 builds off of positive clinical data generated in Quoin's earlier stage open-label study where QRX003 was applied to the arms and lower legs or approximately 20% of each subject's body surface area (BSA). In this pivotal study, QRX003 will be applied to approximately 12-15 subjects twice daily to at least 80% of each of the subjects' BSA thereby generating substantially more safety and efficacy data per subject and will match how QRX003 is intended to be used if regulatory approval is obtained. All subjects recruited into this study are currently receiving off-label systemic therapy and will continue to remain on this treatment for the duration of the study. Study CL-QRX003-002 complements Quoin's other pivotal study, CL-QRX003-003, which is being conducted by Dr. Amy Paller, of Northwestern University, where QRX003 is being administered as monotherapy and subjects do not receive off-label systemic therapy. Quoin anticipates that combined both studies will recruit between 24-30 subjects in 6 U.S. sites and up to 6 international sites. Five of the U.S. sites are already open and the sixth is expected to be opened in June. All international sites are at an advanced stage of preparation for opening. Each of the U.S. and international sites has available cohorts of subjects that are ready to participate in both studies facilitating a rapid pace of recruitment which could enable Quoin to achieve its target of fully completing recruitment before the end of Q1 2026 and to file an NDA for regulatory approval later in the year. Quoin CEO, Dr. Michael Myers, added, 'I am very pleased to announce yet another important and significant milestone for Quoin. With FDA clearance to conduct this study, Quoin is the only company conducting two late-stage whole-body pivotal clinical studies in Netherton Syndrome patients. We believe that the combined data generated from Study CL-QRX003-003, where QRX003 is being administered as monotherapy and this study, CL-QRX003-002, where QRX003 is being tested in conjunction with off-label systemic therapy, has the potential to generate a highly comprehensive safety and efficacy data package that could support the regulatory approval of a treatment for this dreadful disease.' About Quoin Pharmaceuticals 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 comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. For more information, visit: or LinkedIn for updates. Cautionary Note Regarding Forward Looking StatementsThe 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: study CL-QRX003-002 testing the whole-body application of QRX003 in conjunction with off-label systemic therapy in approximately 12-15 subjects, six international sites opening to support study CL-QRX003-003 testing subjects with QRX003 as monotherapy, combined data from Studies CL-QRX0003-002 and CL-QRX003 providing QRX003 with the broadest possible label opportunity post-approval as both monotherapy and adjunct therapy in conjunction with off-label systemic treatments, available cohorts of subjects being ready to be enrolled into the studies facilitating accelerated recruitment at the clinical sites, completing recruitment into both pivotal studies by end of Q1 2026, filing an NDA for regulatory approval later in the year, combined both studies recruiting between 24-30 subjects in 6 US sites and up to 6 international sites, opening a sixth US site in June, and Quoin's belief that its products in development collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa 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, 2024 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 Myers, Ph.D., CEOmmyers@ Investor RelationsPCG AdvisoryJeff Ramsonjramson@ 863-6341
Yahoo
06-05-2025
- Business
- Yahoo
Quoin Pharmaceuticals to Announce First Quarter 2025 Financial Results on Tuesday, May 13, 2025
Quoin Pharmaceuticals, Inc. ASHBURN, Va., May 06, 2025 (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 that it plans to release its financial results for the first quarter ended March 31, 2025, before the market opens on Tuesday, May 13, 2025. The announcement will include an operational update highlighting key achievements from the quarter, recent accomplishments, and financial highlights. 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 comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. For more information, go to: For further information, contact: Quoin Pharmaceuticals Ltd. Michael Myers, Ph.D., CEO mmyers@ Investor Relations PCG Advisory Jeff Ramson jramson@ (646) 863-6341
Yahoo
30-04-2025
- Business
- Yahoo
Quoin Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Rule
ASHBURN, Va., April 30, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the 'Company' or 'Quoin'), a late clinical stage, specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases, today announces that it has received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC ('Nasdaq') stating that the Company has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The notification from Nasdaq confirms that for the last 13 consecutive business days, the closing bid price of the Company's ordinary shares was at or above $1.00 per share. Accordingly, Nasdaq considers the matter closed. About Quoin Pharmaceuticals 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 comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit: or LinkedIn for updates. Cautionary Note Regarding Forward Looking StatementsThe Company cautions that statements in this press release that are not descriptions 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,' 'hope,' 'plan,' 'potential,' 'anticipate,' 'look forward,' 'believe,' 'may,' 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: 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, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma 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 deliver a safe and effective treatment for Netherton Syndrome; whether the Company's studies successfully generate data that is sufficiently robust and comprehensive to support an NDA filing for QRX003 as an approved treatment for Netherton Syndrome; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 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 Myers, Ph.D., CEOmmyers@ Investor RelationsPCG AdvisoryJeff Ramsonjramson@ 863-6341Sign in to access your portfolio
Associated Press
30-04-2025
- Business
- Associated Press
Quoin Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Rule
ASHBURN, Va., April 30, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the 'Company' or 'Quoin'), a late clinical stage, specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases, today announces that it has received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC ('Nasdaq') stating that the Company has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The notification from Nasdaq confirms that for the last 13 consecutive business days, the closing bid price of the Company's ordinary shares was at or above $1.00 per share. Accordingly, Nasdaq considers the matter closed. 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 comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit: or LinkedIn for updates. Cautionary Note Regarding Forward Looking Statements The Company cautions that statements in this press release that are not descriptions 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,' 'hope,' 'plan,' 'potential,' 'anticipate,' 'look forward,' 'believe,' 'may,' 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: 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, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma 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 deliver a safe and effective treatment for Netherton Syndrome; whether the Company's studies successfully generate data that is sufficiently robust and comprehensive to support an NDA filing for QRX003 as an approved treatment for Netherton Syndrome; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 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. Michael Myers, Ph.D., CEO [email protected] Investor Relations PCG Advisory Jeff Ramson [email protected] (646) 863-6341
Associated Press
10-04-2025
- Health
- Associated Press
Quoin Pharmaceuticals Releases Second Episode of its 'Living with Netherton' Series, as part of its ongoing NETHERTON NOW awareness campaign
Episode Highlights a Truly Remarkable Patient Story Spanning 79 Years Video features 79-year-old Norma Coles, believed to be among the earliest individuals ever evaluated for Netherton Syndrome and is available on the company's NETHERTON NOW website ASHBURN, Va., April 10, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) ('Quoin' or the 'Company'), a late clinical-stage specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases, today announced the release of the second episode in its 'Living with Netherton' video series, part of the company's broader NETHERTON NOW awareness campaign. This installment features Norma Coles, a 79-year-old woman whose diagnosis with Netherton Syndrome came decades after she was first evaluated by the condition's namesake, Dr. Edward Netherton. 'Norma's story thoughtfully bridges the earliest history of Netherton Syndrome with today's urgent need for awareness and treatment,' said Denise Carter, Co-Founder and Chief Operating Officer of Quoin Pharmaceuticals. 'Her powerful story reflects the reality of so many others who continue to go undiagnosed and unsupported. 'Living with Netherton' highlights individuals who have gone unheard and unrecognized for far too long, bringing to light the urgent need for effective Netherton Syndrome treatment.' Norma's story reflects the persistent challenges faced by patients living with this rare genetic disorder, including years of misdiagnosis, lack of awareness and limited medical guidance. For decades, she endured fragile skin, recurring rashes and brittle hair described as 'bamboo hair'—a key characteristic of the disease. It wasn't until her mid-50s that Norma was finally diagnosed, revealing a long-forgotten connection to Dr. Netherton himself, who studied her as a child at the Cleveland Clinic in the late 1940s. 'I guess I got it all started,' Norma says in the video, 'but I didn't know about it until I was 58.' Her powerful reflection sheds light on how far the medical community has come, and how far it still must go. Today, 75 years after her first visit to Dr. Netherton, there remains no FDA-approved treatment for Netherton Syndrome. Through the NETHERTON NOW campaign, Quoin is committed to raising awareness, improving education, and building advocacy for individuals and families affected by Netherton Syndrome. The video series is a central part of that effort, sharing real patient experiences to foster understanding of a disease that is often overlooked or misunderstood. 'Norma's story reminds us why our work is critically important,' said Dr. Michael Myers, Co-Founder and Chief Executive Officer of Quoin Pharmaceuticals. 'At a time when there are still no FDA-approved treatments for Netherton Syndrome, her experience illustrates both the long road so many patients have traveled and the urgency of delivering a transformative treatment option. Our ongoing clinical trials of QRX003 have generated encouraging initial data, including meaningful improvements in skin healing, clear reductions in painful inflammation and pruritus while leading to a much enhanced quality of life. We remain deeply committed to completing the development of what we hope will become the first approved treatment for this devastating disease. Stories like Norma's fuel our determination every step of the way.' Quoin's lead product candidate, QRX003, is currently being evaluated in four clinical trials for the treatment of Netherton Syndrome. The Company's goal is to develop the first FDA-approved therapy for the condition and provide meaningful support to a community that has waited far too long for answers. The full video featuring Norma Coles can be viewed here About QRX003 QRX003 is a topical lotion formulated with a proprietary delivery technology that contains a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to perform the function of a specific protein called LEKTI. The absence of LEKTI in Netherton patients leads to excessive skin shedding, resulting in a highly porous and compromised skin barrier. QRX003 is designed to promote a more normalized skin-shedding process and the formation of a stronger and more effective skin barrier. For more information about Quoin's current clinical trials please visit: About Quoin Pharmaceuticals Ltd. Quoin Pharmaceuticals Ltd. is a 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 comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit: or LinkedIn for updates. For more information about Netherton Syndrome, Quoin's clinical programs, or to stay updated on the Netherton Now series, visit 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 'aim,' 'design,' 'expect,' 'hope,' '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: Quoin aims to raising awareness, improving education, and building advocacy for individuals and families affected by Netherton Syndrome; completing the development of what Quoin hopes will become the first approved treatment for Netherton Syndrome; the Company's goal to develop the first FDA-approved therapy for Netherton Syndrome and provide meaningful support to a community that has waited far too long for answers; the potential efficacy of QRX003 as a treatment for Netherton Syndrome; 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, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma 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 deliver a safe and effective treatment for Netherton Syndrome; whether the Company's studies are successful in generating data that is sufficiently robust and comprehensive to support an NDA filing for QRX003 as an approved treatment for Netherton Syndrome; and other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 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. Quoin Pharmaceuticals Ltd. Michael Myers, Ph.D., CEO PCG Advisory
