Compumedics Achieves World-First Adult and Child Optimized Recordings from a Single MEG System
MELBOURNE, Australia--(BUSINESS WIRE)-- Compumedics Limited (ASX: CMP), a world leading supplier of innovative medical technology for patient monitoring, has in collaboration with Beijing Fistar and TJNU performed recordings of both adults and children. The site at TJNU is equipped with an Orion LifeSpan™ MEG.
'Most advanced MEG capability anywhere in the world'
Professor Xuejun Bai is Vice President of TJNU, Head of the MEG Laboratory, Director of the Brain Functional Imaging Centre and former Director of the Chinese Psychological Society. He has published more than 300 scientific papers and has been awarded ten patents. Prof. Bai commented:
' The Orion LifeSpan MEG recently installed by Compumedics at TJNU has been a revolution in our ability to study mental processes of both children and adults, or even the two simultaneously. The system has already proven itself to be extremely sensitive, accurate and reliable. My team have been hard at work doing MEG measurements, analyzing the resulting data and uncovering new neuroscientific findings. I can say without reservation that the Orion LifeSpan has given TJNU the most advanced MEG capability anywhere in the world.'
Ability to Accurately Scan Both Children and Adults
MEG is a functional neuroimaging technique for mapping brain activity. It uses highly sensitive detectors to record the naturally occurring magnetic fields produced by electrical current flows within the brain. Because magnetic fields drop off very rapidly with distance, the sensors should be as close as possible to the sources of the brain signals. A child's small head in an adult size helmet results in sensors far from the brain, leading to small signals. A dedicated smaller helmet yields clearer and more accurate data. More precise data always leads to better research understanding and improved patient outcomes.
World's First Recordings
After installation of the Orion LifeSpan™ MEG at TJNU, a series of measurements were undertaken to demonstrate that the theoretical advantage of the system during pediatric recordings would be borne out in practice.
Founder and Executive Chairman Dr David Burton commented: 'These recordings represented the first time a single MEG system had delivered high-quality scans for both children and adults. This breakthrough was at the world's most advanced MEG lab at TJNU, which is equipped with a Compumedics Orion LifeSpan MEG system.
'Compumedics has invested nearly a decade and many millions of dollars to develop the Orion LifeSpan MEG,' he said. 'The system represents a major leap in magnetoencephalography, with dual-helmet capability for pediatric and adult brain scanning, fully integrated with our gold-standard brain analytics CURRY software.
'It's incredibly rewarding to see these efforts translating into strong initial sales, global interest and the potential for improved brain health, among both children and adults worldwide.'
A four-year-old female was presented with a series of tones and measured with both the adult and pediatric helmet. The results showed significantly stronger detection in the pediatric helmet. Localizations showed more precise determination of where the brain had been activated by the tones. The physics of magnetic field decay and the design philosophy of the Orion LifeSpan™ MEG were confirmed
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RAD 2025: Long-Term Data on Nemluvio ® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years
ZUG, Switzerland--(BUSINESS WIRE)--Galderma (SIX: GALD) today announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years. 1 These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025. BALDO SCASSELLATI SFORZOLINI, M.D., PHD. GALDERMA Expand Atopic dermatitis affects more than 230 million people worldwide. 3 Often reported as one of patients' most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians. 4-7 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. 3,8,9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis. 8,10 Nemluvio is also the first and only biologic approved for atopic dermatitis as well as prurigo nodularis with four-week dosing intervals from the start of treatment, and the only option to move to eight-week dosing intervals for appropriate patients with atopic dermatitis. 9 'The relentless itch of atopic dermatitis is not just a symptom; it's a constant burden that disrupts sleep, concentration, and the simple joys of life. Nemolizumab has demonstrated its impact on both itch and skin lesions in atopic dermatitis extensively over the years, and these new data, demonstrating its benefit up to two years, add another layer of confidence to that.' PROFESSOR JONATHAN SILVERBERG Expand The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients. 1 Results to be presented at the RAD Conference will show that Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years. 1 At week 104 in evaluable patients, the interim analysis shows that: More than 85% achieved a 75% reduction in the Eczema Area and Severity Index (EASI) 1 Approximately 85% and 70% achieved an at least four-point improvement in itch, and being itch free or nearly itch free, respectively, when assessed using the SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Improvements in sleep mirrored those in itch 1 Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator's Global Assessment (IGA) score 1 Patients' quality of life improved over time, as measured by the Dermatology Life Quality Index (DLQI) 1 Results also reinforce Nemluvio's rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naïve to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score. 1 Nemluvio was well tolerated in the long-term treatment of atopic dermatitis and no new safety signals were identified. 1 Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio's rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis. 11,12 Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis. 9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. 9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional regulatory submissions and reviews are ongoing. More details on Galderma's scientific presentations at RAD can be found here. About Nemluvio Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga ® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients. 13,14 About atopic dermatitis Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions. 3,15,16 It affects more than 230 million people worldwide. 3 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis. 17 Important Safety Information Indications: NEMLUVIO ® (nemolizumab-ilto) is a prescription medicine used: to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age. to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age. Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you: are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO. are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: Breathing problems or wheezing Swelling of the face, lips, mouth, tongue, or throat Fainting, dizziness, feeling lightheaded Fast pulse Swollen lymph nodes Joint pain Fever Skin rash (red or rough skin) Nausea or vomiting General ill feeling Cramps in your stomach area The most common side effects of NEMLUVIO include: Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches) These are not all of the possible side effects of NEMLUVIO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088. Please see full Prescribing Information including Patient Information. About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0 Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286-1 Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/ Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932 Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966 Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/ Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025 Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi: 10.1002/cti2.1390 Silverberg JI, et al. Nemolizumab was associated with rapid and significant improvements in itch and sleep in patients with moderate-to-severe atopic dermatitis: Results from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2). Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Yosipovitch G, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025 Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911 Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond)
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RAD 2025: Long-Term Data on Nemluvio® (nemolizumab) Demonstrate its Favorable Safety Profile and Sustained and Increased Improvements in Itch and Skin Lesions in Patients With Atopic Dermatitis up to Two Years
New interim two-year data from a long-term extension study of Nemluvio in atopic dermatitis reinforce its rapid onset of action and demonstrate its lasting impact across multiple clinical and patient reported outcomes including itch and skin lesions1 Results build on data from the phase III ARCADIA program, showing Nemluvio's consistent safety profile and sustained and increased improvements in efficacy outcomes in atopic dermatitis patients during prolonged treatment up to two years1,2 Two-year data from a long-term extension study of Nemluvio in prurigo nodularis will also be presented later in June at the International Congress of Dermatology ZUG, Switzerland, June 06, 2025--(BUSINESS WIRE)--Galderma (SIX: GALD) today announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years.1 These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025. "With Nemluvio now being launched in several countries, it's so encouraging that we continue to see its robust evidence base expand. Long-term data is pivotal to this, highlighting the profound impact this innovative treatment can have in atopic dermatitis well into the future." BALDO SCASSELLATI SFORZOLINI, M.D., PHD. GLOBAL HEAD OF RESEARCH & DEVELOPMENT GALDERMA Atopic dermatitis affects more than 230 million people worldwide.3 Often reported as one of patients' most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.4-7 Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.3,8,9 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis.8,10 Nemluvio is also the first and only biologic approved for atopic dermatitis as well as prurigo nodularis with four-week dosing intervals from the start of treatment, and the only option to move to eight-week dosing intervals for appropriate patients with atopic dermatitis.9 "The relentless itch of atopic dermatitis is not just a symptom; it's a constant burden that disrupts sleep, concentration, and the simple joys of life. Nemolizumab has demonstrated its impact on both itch and skin lesions in atopic dermatitis extensively over the years, and these new data, demonstrating its benefit up to two years, add another layer of confidence to that."PROFESSOR JONATHAN SILVERBERG LEAD INVESTIGATOR OF THE ARCADIA CLINICAL PROGRAM, PROFESSOR OF DERMATOLOGY, GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES, UNITED STATES The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients.1 Results to be presented at the RAD Conference will show that Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years.1 At week 104 in evaluable patients, the interim analysis shows that: More than 85% achieved a 75% reduction in the Eczema Area and Severity Index (EASI)1 Approximately 85% and 70% achieved an at least four-point improvement in itch, and being itch free or nearly itch free, respectively, when assessed using the SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Improvements in sleep mirrored those in itch1 Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator's Global Assessment (IGA) score1 Patients' quality of life improved over time, as measured by the Dermatology Life Quality Index (DLQI)1 Results also reinforce Nemluvio's rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naïve to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score.1 Nemluvio was well tolerated in the long-term treatment of atopic dermatitis and no new safety signals were identified.1 Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio's rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis.11,12 Nemluvio was first approved in August 2024 by the United States Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis.9 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.9 To date, Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the European Commission. Additional regulatory submissions and reviews are ongoing. More details on Galderma's scientific presentations at RAD can be found here. About NemluvioNemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.13,14 About atopic dermatitisAtopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions.3,15,16 It affects more than 230 million people worldwide.3 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis.17 Important Safety InformationIndications: NEMLUVIO® (nemolizumab-ilto) is a prescription medicine used: to treat adults and children 12 years of age and older with moderate-to-severe eczema (atopic dermatitis or AD) in combination with prescription therapies used on the skin (topical) when the eczema is not well controlled by topical therapies alone. It is not known if NEMLUVIO is safe and effective in children with atopic dermatitis under 12 years of age. to treat adults with prurigo nodularis. It is not known if NEMLUVIO is safe and effective in children with prurigo nodularis under 18 years of age. Do not take NEMLUVIO if you are allergic to nemolizumab-ilto or to any ingredients in NEMLUVIO. Before taking NEMLUVIO, tell your healthcare provider about all of your medical conditions, including if you: are scheduled to receive any vaccination. You should not receive a live vaccine right before or during treatment with NEMLUVIO. are pregnant or plan to become pregnant. It is not known whether NEMLUVIO will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known whether NEMLUVIO passes into your breast milk and if it can harm your baby. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NEMLUVIO may cause serious side effects, including: allergic reactions (hypersensitivity). Stop using NEMLUVIO and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: Breathing problems or wheezing Swelling of the face, lips, mouth, tongue, or throat Fainting, dizziness, feeling lightheaded Fast pulse Swollen lymph nodes Joint pain Fever Skin rash (red or rough skin) Nausea or vomiting General ill feeling Cramps in your stomach area The most common side effects of NEMLUVIO include: Eczema: headache, joint pain, hives (itchy red rash or wheals), and muscle aches Prurigo Nodularis: headache and skin rashes: atopic dermatitis (a type of eczema), eczema, and eczema nummular (scattered circular patches) These are not all of the possible side effects of NEMLUVIO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088. Please see full Prescribing Information including Patient Information. About GaldermaGalderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: References Silverberg, JI, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in the ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0 Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet. 2020;396(10247):345-360. doi: 10.1016/S0140- 6736(20)31286-1 Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/ Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol. 2022;7:102:adv00830. doi: 10.2340/actadv.v102.3932 Durno N, et al. Biologics and oral systemic treatment preferences in patients and physicians for moderate-to-severe atopic dermatitis: a discrete choice experiment in the United Kingdom and Germany. J Derm Treatment. 2024;35(1). doi: 10.1080/09546634.2024.2417966 Penton H, et al. Assessing Response in Atopic Dermatitis: A Systematic Review of the Psychometric Performance of Measures Used in HTAs and Clinical Trials. Dermatol Ther (Heidelb). 2023;13(11):2549-2571. doi: 10.1007/s13555-023-01038-3 Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/ Nemluvio U.S. Prescribing Information. Available online. Accessed May 2025 Kwatra SG, Misery L, Clibborn C, Steinhoff M. Molecular and cellular mechanisms of itch and pain in atopic dermatitis and implications for novel therapeutics. Clin Transl Immunology. 2022;11(5):e1390. doi: 10.1002/cti2.1390 Silverberg JI, et al. Nemolizumab was associated with rapid and significant improvements in itch and sleep in patients with moderate-to-severe atopic dermatitis: Results from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2). Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Yosipovitch G, et al. Nemolizumab long-term efficacy and safety up to 52 weeks in the OLYMPIA open-label extension study in patients with prurigo nodularis: An interim analysis. Presented at Revolutionizing Atopic Dermatitis Conference 2025; June 6-7; Nashville, United States. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed May 2025 Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed May 2025 Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911 Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci. 2020;21(8):2867. doi: Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi:10.7861/clinmed.2021-0257 View source version on Contacts For further information: Christian Marcoux, Communications +41 76 315 26 50 Richard HarbinsonCorporate Communications +41 76 210 60 62 Céline Buguet Franchises and R&D Communications Director +41 76 249 90 87 Emil IvanovHead of Strategy, Investor Relations, and +41 21 642 78 12 Jessica CohenInvestor Relations and Strategy +41 21 642 76 43 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Idorsia publishes invitations to bondholder meetings
Ad hoc announcement pursuant to Art. 53 LR Bondholder meetings will take place on Wednesday, June 25, 2025, to vote on proposals to amend the terms of the two outstanding convertible bonds CB 2025 and CB 2028 Allschwil, Switzerland – June 6, 2025Idorsia Ltd (SIX: IDIA) today announced that following the expiry of the appeal period for the amended terms approved at the CB 2025 bondholder meeting of February 25, 2025 – during which no appeal was filed – it has published invitations to the next bondholder meetings for holders of its outstanding CHF 200 million convertible bonds maturing in 2025 (CB 2025; ISIN CH0426820350), and CHF 600 million convertible bonds maturing in 2028 (CB 2028; ISIN CH1128004079). At the meetings, the company will propose changing the current terms of the CB 2025 and CB 2028 as part of the larger holistic restructuring, as announced in a press release on February 26, 2025, and an update published on May 21, 2025. To date, approximately 87% of the holders of the CB 2025 and 90% of holders of the CB 2028 have entered a legally binding lockup agreement in support of the holistic restructuring. Such bondholders have committed to vote in favour of the proposed amendments to the terms of the CB 2025 and CB 2028 at or before the meeting. The amendment of the terms of the CB 2025 and CB 2028 will be conditional on the consummation of the exchange offer, which is expected to be launched around or following the date of the bondholder meetings. Bondholders can access the invitations to the two bondholder meetings scheduled for Wednesday, June 25, 2025, including the terms of the resolution and additional information about the meeting, as well as a financial status report as of April 30, 2025, at the following links: and Notes to the editor About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 – – The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF
