Latest news with #Leqembi
Yahoo
5 days ago
- Business
- Yahoo
BioArctic's Capital Markets Day 2025 - entering a new era of growth
STOCKHOLM, June 2, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) today welcomes investors, analysts and financial media to the company's Capital Markets Day. The event, which starts at 10:30 CET, will be broadcast live online. Over the past 20 years, BioArctic has built a thriving company based on a foundation of solid science and innovation, strong finances and an organization with well-educated staff and a value-driven corporate culture. At the Capital Markets Day, management will outline BioArctic's ambitions for 2030 which focuses on building Sweden's next major pharmaceutical company. This will be achieved by: building a balanced and broad pipeline with projects in all stages of development, adding additional successful global partnerships, and establishing Leqembi® as a treatment for Alzheimer's disease in the Nordics ensuring finances that allow for both investing in growth while giving recurring dividends to shareholders. To achieve this, the company will accelerate innovation into a broader area of severe brain diseases, proactively work with business development to maximize the value of each project, and work to ensure a successful launch of Leqembi in the Nordic region. The presentation for the Capital Markets Day can be found on A recording of the Capital Markets Day will be available later today on BioArctic's website. AGENDA 10:30 BioArctic today and tomorrow Precision neurology and severe brain disease experiencing unprecedented opportunities for innovation. Chief Executive Officer Gunilla Osswald will discuss how BioArctic is positioning itself to capture these global possibilities and outline the company's ambitions toward 2030. 11:00 FinancialsFollowing the recent license agreement with Bristol Myers Squibb and with continuous royalties from Leqembi sales, BioArctic expects to achieve profitability from this year onwards. Anders Martin-Löf, Chief Financial Officer, will outline what this strengthened financial position means for shareholders and BioArctic's future opportunities. 11:20 R&D StrategyBased on the same principle as Leqembi, BioArctic has built a project portfolio with selective antibodies targeting aggregated forms of misfolded proteins in the brain. Chief R&D Officer Johanna Fälting will outline the overarching research strategy and explain how BioArctic's integrated antibody and BrainTransporter™ platforms create opportunities across several disease areas. 11:50 Q&A 12:10 Lunch 13:00 LeqembiLeqembi is the first fully approved disease-modifying treatment for early Alzheimer's disease, marking a transformational shift in the treatment landscape. Anna-Kaija Grönblad, Chief Commercial Officer, will discuss this evolving paradigm, provide insights into global and European market developments, and outline BioArctic's preparations for the Nordic launch. 13:20 Key opinion leader: Disease modifying treatment for Alzheimer's disease in clinical useSince the initial approval of Leqembi in the United States in January 2023, clinicians have gained important real-world experience with this groundbreaking therapy for early Alzheimer's disease. Professor Lawrence S. Honig from Columbia University's Department of Neurology will present clinical insights from US practice and discuss the practical challenges and opportunities of implementing this new treatment paradigm. 14:00 Q&A 14:15 BrainTransporter-technologyBiological drugs hold enormous potential for treating brain diseases, but the blood-brain barrier has historically prevented their effective delivery. Chief Scientific Officer Per-Ola Freskgård will present how BioArctic's breakthrough BrainTransporter technology can deliver antibodies with up to 70 times greater brain exposure and superior distribution and discuss the commercial opportunities this proprietary platform creates. 14:55 ExidavnemabBioArctic's antibody exidavnemab targets alpha-synuclein, a key protein involved in multiple neurodegenerative conditions. Gabrielle Åhlberg Hillert, Chief Medical Officer, will provide an update on the Phase 2 program, explain how exidavnemab differentiates from other late-stage antibodies, and discuss how it could address significant unmet medical needs in alpha-synuclein diseases such as Parkinson's disease, Multiple System Atrophy, and Lewy body dementia. 15.15 Q&A 15.30 Concluding remarks Short summary by Gunilla Osswald, Chief Executive Officer The information was released for public disclosure, through the agency of the contact persons below, on June 2, 2025, at 10:30 CET. For further information, please contact: Oskar Bosson, VP Communications and Investor RelationsE-mail: +46 70 410 71 80 Charlotte af Klercker, Senior Director Sustainability and CommunicationsE-mail: Telephone: +46 73 515 09 70 About BioArctic ABBioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company is the originator of Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with Eisai. BioArctic has a broad research portfolio within Alzheimer's disease, Parkinson's disease, ALS and enzyme deficiency diseases. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which improves the transport of drugs into the brain. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For more information, please visit This information was brought to you by Cision The following files are available for download: BioArctic’s Capital Markets Day 2025 â€" entering a new era of growth View original content: SOURCE BioArctic
Yahoo
5 days ago
- Business
- Yahoo
BioArctic's Capital Markets Day 2025 - entering a new era of growth
STOCKHOLM, June 2, 2025 /PRNewswire/ -- BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) today welcomes investors, analysts and financial media to the company's Capital Markets Day. The event, which starts at 10:30 CET, will be broadcast live online. Over the past 20 years, BioArctic has built a thriving company based on a foundation of solid science and innovation, strong finances and an organization with well-educated staff and a value-driven corporate culture. At the Capital Markets Day, management will outline BioArctic's ambitions for 2030 which focuses on building Sweden's next major pharmaceutical company. This will be achieved by: building a balanced and broad pipeline with projects in all stages of development, adding additional successful global partnerships, and establishing Leqembi® as a treatment for Alzheimer's disease in the Nordics ensuring finances that allow for both investing in growth while giving recurring dividends to shareholders. To achieve this, the company will accelerate innovation into a broader area of severe brain diseases, proactively work with business development to maximize the value of each project, and work to ensure a successful launch of Leqembi in the Nordic region. The presentation for the Capital Markets Day can be found on A recording of the Capital Markets Day will be available later today on BioArctic's website. AGENDA 10:30 BioArctic today and tomorrow Precision neurology and severe brain disease experiencing unprecedented opportunities for innovation. Chief Executive Officer Gunilla Osswald will discuss how BioArctic is positioning itself to capture these global possibilities and outline the company's ambitions toward 2030. 11:00 FinancialsFollowing the recent license agreement with Bristol Myers Squibb and with continuous royalties from Leqembi sales, BioArctic expects to achieve profitability from this year onwards. Anders Martin-Löf, Chief Financial Officer, will outline what this strengthened financial position means for shareholders and BioArctic's future opportunities. 11:20 R&D StrategyBased on the same principle as Leqembi, BioArctic has built a project portfolio with selective antibodies targeting aggregated forms of misfolded proteins in the brain. Chief R&D Officer Johanna Fälting will outline the overarching research strategy and explain how BioArctic's integrated antibody and BrainTransporter™ platforms create opportunities across several disease areas. 11:50 Q&A 12:10 Lunch 13:00 LeqembiLeqembi is the first fully approved disease-modifying treatment for early Alzheimer's disease, marking a transformational shift in the treatment landscape. Anna-Kaija Grönblad, Chief Commercial Officer, will discuss this evolving paradigm, provide insights into global and European market developments, and outline BioArctic's preparations for the Nordic launch. 13:20 Key opinion leader: Disease modifying treatment for Alzheimer's disease in clinical useSince the initial approval of Leqembi in the United States in January 2023, clinicians have gained important real-world experience with this groundbreaking therapy for early Alzheimer's disease. Professor Lawrence S. Honig from Columbia University's Department of Neurology will present clinical insights from US practice and discuss the practical challenges and opportunities of implementing this new treatment paradigm. 14:00 Q&A 14:15 BrainTransporter-technologyBiological drugs hold enormous potential for treating brain diseases, but the blood-brain barrier has historically prevented their effective delivery. Chief Scientific Officer Per-Ola Freskgård will present how BioArctic's breakthrough BrainTransporter technology can deliver antibodies with up to 70 times greater brain exposure and superior distribution and discuss the commercial opportunities this proprietary platform creates. 14:55 ExidavnemabBioArctic's antibody exidavnemab targets alpha-synuclein, a key protein involved in multiple neurodegenerative conditions. Gabrielle Åhlberg Hillert, Chief Medical Officer, will provide an update on the Phase 2 program, explain how exidavnemab differentiates from other late-stage antibodies, and discuss how it could address significant unmet medical needs in alpha-synuclein diseases such as Parkinson's disease, Multiple System Atrophy, and Lewy body dementia. 15.15 Q&A 15.30 Concluding remarks Short summary by Gunilla Osswald, Chief Executive Officer The information was released for public disclosure, through the agency of the contact persons below, on June 2, 2025, at 10:30 CET. For further information, please contact: Oskar Bosson, VP Communications and Investor RelationsE-mail: +46 70 410 71 80 Charlotte af Klercker, Senior Director Sustainability and CommunicationsE-mail: Telephone: +46 73 515 09 70 About BioArctic ABBioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company is the originator of Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with Eisai. BioArctic has a broad research portfolio within Alzheimer's disease, Parkinson's disease, ALS and enzyme deficiency diseases. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which improves the transport of drugs into the brain. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For more information, please visit This information was brought to you by Cision The following files are available for download: BioArctic’s Capital Markets Day 2025 â€" entering a new era of growth View original content: SOURCE BioArctic Sign in to access your portfolio
Yahoo
29-05-2025
- Business
- Yahoo
Helix releases pharmacogenomics tests for use in neurology and oncology
US-based genomics company Helix has released a new suite of pharmacogenomics (PGx) tests, widening its portfolio to offer personalised patient care in neurology and oncology. The suite includes a PGx Fluoropyrimidines DPYD test to detect individuals with dihydropyrimidine dehydrogenase (DPYD) gene variants at risk for side effects from certain chemotherapies, aligning with the recent guidelines from the National Comprehensive Cancer Network. The DPYD test provides insights into a patient's metabolism of cancer treatments. It targets therapies used in treating breast, pancreatic, head and neck, colorectal, and oesophageal cancers. Additionally, the suite includes the PGx APOE test to evaluate the status of apolipoprotein E (APOE) relevant to Alzheimer's drugs. It assesses the risk of serious adverse effects such as amyloid-related imaging abnormalities (ARIA) for individuals treated with Leqembi or Kisunla. These drugs have US Food and Drug Administration (FDA) boxed warnings for individuals with two copies of the APOE ε4 allele. With these tests, Helix now covers all neurology and oncology-associated PGx haplotypes cited in the agency's warnings. The company noted that its PGx tests offer accuracy across varied populations, utilising its Exome+ assay and comprehensive star allele caller. Its Sequence Once, Query Often model allows for exomes to be sequenced just once, with subsequent genetic tests not requiring additional samples. This facilitates rapid results, enabling genetic insights at the point of care. Helix's latest PGx tests encompass medications for cancer, cardiovascular diseases, pain management, gastrointestinal conditions, and anaesthesia guidance. These tests add to the company's existing PGx offerings for blood clotting, mental health, and immune suppression treatments. In addition, Helix has also developed the Helix Research Network in collaboration with its partners. This precision clinical research network comprises health systems focused on integrating genomics into routine care and advancing human health through genomics research. It also creates real-world evidence to support a wide range of initiatives, including studies showing the genomics' clinical use. Helix chief science officer Will Lee said: 'By focusing on patients with neurodegenerative conditions and cancer, and actively identifying those at higher risk for adverse outcomes, we can help providers treat vulnerable patients more precisely and effectively.' "Helix releases pharmacogenomics tests for use in neurology and oncology" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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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Business Standard
20-05-2025
- Health
- Business Standard
First blood test for Alzheimer's in US from June, starting at 50 hospitals
The first blood test to help diagnose Alzheimer's disease will be available from late June in the US following regulatory clearance for its use last week, according to the Japanese company behind the innovation. The test will initially be available at about 50 American research institutes and hospitals that specialize in Alzheimer's disease, Goki Ishikawa, head of Fujirebio Diagnostics Inc. that developed the test, said in an interview Tuesday. The company, a unit of Japan's H.U. Group Holdings Inc., is also partnering with bigger rivals like Beckman Coulter Inc. to help develop and manufacture their products, he said. The Food and Drug Administration cleared the blood test to help diagnose Alzheimer's disease last week, potentially making it easier to find and treat patients with the memory-robbing disease that affects nearly 7 million Americans. The test was cleared for use in people at least 55 years old and who exhibit signs of the disease. It is designed to detect amyloid, a protein that can build up in the brain and is a hallmark of Alzheimer's, the most common form of dementia in the elderly. The process, which takes roughly 30 minutes from drawing the blood to diagnosis, will be available to patients at a fraction of the cost of a PET scan. The method is viewed as a critical step in making new types of Alzheimer's treatments widely accessible. Until now, patients typically have to get a specialized PET scan to detect amyloid in their brains or undergo cerebrospinal fluid tests, both of which are more expensive and invasive. The lack of quick and easy tests has until now slowed the rollout of new Alzheimer's drugs like Eisai Co. and Biogen Inc.'s Leqembi and Eli Lilly & Co.'s Kisunla. The company plans to file data to seek approvals in Japan as early as August and Europe within this year, Ishikawa said. In China, Fujirebio's undisclosed partner will probably submit data to regulators next year, he added. In India, it partners with Agappe Diagnostics Ltd. 'We have a presence in Japan but that's not necessarily the case in markets overseas,' said Ishikawa. 'We can't get the market shares by ourselves, but if we supply the raw materials to partners, we can benefit through them.'
Yahoo
20-05-2025
- Health
- Yahoo
FDA approves blood test to detect Alzheimer's disease
Without expensive or invasive tests, diagnosing Alzheimer's disease has been largely a look at symptoms and the assessment of an expert or use of expensive and invasive tests. But that's likely to change with news that the U.S. Food and Drug Administration has approved a blood test that helps with the diagnosis. The test has a complicated name: The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. But the goal of the test, created by Fujirebio Diagnostics, is simple: Early detection of beta-amyloid plaques linked to the neurocognitive disease in adults 55 and older who are exhibiting signs and symptoms of the disorder. 'Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined,' FDA Commissioner Dr. Martin A. Makary said in a news release. 'Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.' The test measures two proteins from human plasma — forms of tau and amyloid — which have been linked to the disease, calculating a ratio that 'is correlated to the presence or absence of amyloid plaques in the patient's brain, reducing the need' for an expensive positron emission tomography (PET) brain scan, which not only costs a lot, but exposes one to radiation. The other option, a lumbar puncture, or spinal tap, is sometimes used to look at cerebrospinal fluid to detect the presence of beta-amyloid. The new test relies on a simple blood draw. As Deseret News has reported, blood tests can speed recruiting for research, reduce wait times and make access to treatments easier. The data used to win FDA approval included a comparison of findings from 499 individual plasma samples taken from adults who were cognitively impaired against findings from an amyloid PET scan and the spinal tap samples. Nearly 92% of those who showed amyloid on the other tests also were positive signs of amyloid on the new blood test. Just over 97% of those with negative blood test results were also negative on the PET scan and spinal fluid test. The test was indeterminate in fewer than 20% of the samples. 'These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer's disease at the time of the test in patients who are cognitively impaired. The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information,' according to the FDA. The release noted the main risks are the possibility of a false positive or a false negative. The former could cause distress, unneeded treatment for Alzheimer's and delay in correct diagnosis. The latter could delay treatment for Alzheimer's at a time when early treatment yields the best results for certain medications, including Leqembi, which slows progression of the disease. 'Importantly, the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is not intended as a screening or stand-alone diagnostic test and other clinical evaluations or additional tests should be used for determining treatment options,' per the FDA. There is no cure at this time, but recent treatments have slowed progress, making early detection vital. The new test was granted 'breakthrough device' designation, meaning that it aids 'more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.' It was granted approval through the pathway that says a new submission is 'substantially equivalent' to an already authorized device — in this case, the test that uses a spinal tap and cerebrospinal fluid samples.
