Latest news with #AANAnnualMeeting
Yahoo
09-04-2025
- Health
- Yahoo
Quest Diagnostics Launches New AD-Detect™ Blood Test to Aid in Confirming Alzheimer's Disease
In an oral presentation at the 2025 AAN Annual Meeting, Quest scientists presented data suggesting the test can accurately assess Alzheimer's disease pathology with greater than 90% sensitivity and specificity SECAUCUS, N.J., April 9, 2025 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, including advanced diagnostics for brain health, today announced the launch of a new laboratory blood test designed to help physicians confirm amyloid brain pathology due to Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or dementia. The laboratory-developed test, named AD-Detect™ Abeta 42/40 and p-tau217 Evaluation, combines results of blood levels of amyloid beta (AB) 42/40 determined by the company's proprietary tandem mass spectrometry techniques with blood levels of p-tau217 determined by an in vitro immunoassay test. The test results are then used to produce the AD-Detect Likelihood Score™, a composite interpretation created through a proprietary algorithm validated utilizing a well-characterized cohort from the 1Florida Alzheimer's Disease Research Center (ADRC). The new Quest test panel builds on prior AD-Detect tests that individually assess AB 42/40 and p-tau217, as well as p-tau181 and the ApoE isoform, a genetic risk marker. Those tests help providers assess risk of AD rather than confirm likelihood of amyloid brain pathology due to AD. "Quest's AD-Detect suite of advanced diagnostics has grown to include a range of validated blood-based biomarkers, giving providers options for personalizing testing for the individual patient," said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. "Quest's innovations in blood testing combined with our broad patient access are making it easier, faster and more affordable to evaluate patients for AD and other complex diseases." Research demonstrates test's strong alignment with PETIn AD, a protein called amyloid forms plaques in the brain, triggering changes in another protein, tau, and causing it to twist into tangles. These plaques and tangles disrupt brain cell function while also causing abnormal levels of both proteins to circulate in the blood stream. In an oral presentation given this week at the American Academy of Neurology (AAN)'s Annual Meeting in San Diego, Quest researchers presented data demonstrating that the new test would have a positive predictive value (PPV, the likelihood of disease) of 89% and negative predictive value (NPV, the likelihood there is no disease) of 89% in a population with mild cognitive impairment when the test cut offs were set at 91% sensitivity and 91% specificity. The addition of ApoE, a genetic risk marker, further improved the predictive values. The percentage of patients with likelihood of indeterminate risk was 15%, which decreased to 10% when ApoE test results were included. Importantly, the population was heterogenous and had a low prevalence of beta amyloid PET positivity (39.1% for all patients and 46% for those with MCI or AD), suggesting the test's reliability in a real-world population that includes individuals who do not have AD. The researchers also categorized 4,326 "real-world specimens" tested by Quest for AB 42/40, p-tau217 and ApoE4 values. The model and cut points categorized these specimens as having 42% high likelihood, 51% low likelihood, and 7% indeterminant likelihood for PET positivity. "As the population ages and new therapies emerge, our new AD-Detect test will help fill the need for scalable, high-volume solutions that broaden access to robust and affordable evaluation of AD," said study co-author Michael Racke, MD, a board-certified neurologist and Medical Director of Neurology at Quest Diagnostics. "Our new test fulfills acceptable performance criteria set forth by the CEOi. We believe it will give providers greater confidence to move patients with a high likelihood score for AD more quickly on the path to treatment and potentially prevent the use of PET and lumbar puncture in patients whose blood values strongly indicate they do not have AD." While amyloid PET imaging and cerebral spinal fluid testing are established methods for aiding the diagnosis of AD, they are significantly more expensive, invasive and specialist-dependent than blood-based tests. The study's strengths included significant ethnic diversity in the population (over 50% Hispanic) while limitations included using a predictive model that did not evaluate performance of the biomarkers in the context of non-AD causes of dementia. The study adds to a growing body of research on the Quest AD-Detect test portfolio, including studies published in the Journal of Investigative Medicine, Frontiers in Neurology and Alzheimer's & Dementia. Broadening access to quality AD assessment With the exception of New York, physicians in the United States may now order the test.1 Patients with a physician's order can provide a blood draw for testing through Quest's network of patient sites. Quest maintains approximately 8,000 patient access points, including an extensive patient service center network of approximately 2,000 locations in the U.S., as well as phlebotomists in physician offices and mobile phlebotomy services. Specimens will be transported for testing to Quest's state-of-the-art laboratory in San Juan Capistrano, California. Nearly 7 million Americans have Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. Approximately 12-18% of adults over the age of sixty are living with mild cognitive impairment, a potential sign of AD. Seventy-seven percent of physicians say new therapies will transform Alzheimer's into a chronic, manageable disease, and 94% of physicians say blood tests would be more cost effective for the healthcare system compared to more invasive methods of detection (e.g., lumbar puncture, imaging studies) according to a special report from Quest. Quest is committed to developing innovative advanced diagnostics to aid in evaluating AD and other brain diseases. For more information, visit About Quest DiagnosticsQuest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. 1 Except in New York state, where the company plans to apply for approval to offer the test clinically. View original content to download multimedia: SOURCE Quest Diagnostics Sign in to access your portfolio
Associated Press
09-04-2025
- Health
- Associated Press
Quest Diagnostics Launches New AD-Detect™ Blood Test to Aid in Confirming Alzheimer's Disease
In an oral presentation at the 2025 AAN Annual Meeting, Quest scientists presented data suggesting the test can accurately assess Alzheimer's disease pathology with greater than 90% sensitivity and specificity SECAUCUS, N.J., April 9, 2025 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, including advanced diagnostics for brain health, today announced the launch of a new laboratory blood test designed to help physicians confirm amyloid brain pathology due to Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or dementia. The laboratory-developed test, named AD-Detect™ Abeta 42/40 and p-tau217 Evaluation, combines results of blood levels of amyloid beta (AB) 42/40 determined by the company's proprietary tandem mass spectrometry techniques with blood levels of p-tau217 determined by an in vitro immunoassay test. The test results are then used to produce the AD-Detect Likelihood Score™, a composite interpretation created through a proprietary algorithm validated utilizing a well-characterized cohort from the 1Florida Alzheimer's Disease Research Center (ADRC). The new Quest test panel builds on prior AD-Detect tests that individually assess AB 42/40 and p-tau217, as well as p-tau181 and the ApoE isoform, a genetic risk marker. Those tests help providers assess risk of AD rather than confirm likelihood of amyloid brain pathology due to AD. 'Quest's AD-Detect suite of advanced diagnostics has grown to include a range of validated blood-based biomarkers, giving providers options for personalizing testing for the individual patient,' said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. 'Quest's innovations in blood testing combined with our broad patient access are making it easier, faster and more affordable to evaluate patients for AD and other complex diseases.' Research demonstrates test's strong alignment with PET In AD, a protein called amyloid forms plaques in the brain, triggering changes in another protein, tau, and causing it to twist into tangles. These plaques and tangles disrupt brain cell function while also causing abnormal levels of both proteins to circulate in the blood stream. In an oral presentation given this week at the American Academy of Neurology (AAN)'s Annual Meeting in San Diego, Quest researchers presented data demonstrating that the new test would have a positive predictive value (PPV, the likelihood of disease) of 89% and negative predictive value (NPV, the likelihood there is no disease) of 89% in a population with mild cognitive impairment when the test cut offs were set at 91% sensitivity and 91% specificity. The addition of ApoE, a genetic risk marker, further improved the predictive values. The percentage of patients with likelihood of indeterminate risk was 15%, which decreased to 10% when ApoE test results were included. Importantly, the population was heterogenous and had a low prevalence of beta amyloid PET positivity (39.1% for all patients and 46% for those with MCI or AD), suggesting the test's reliability in a real-world population that includes individuals who do not have AD. The researchers also categorized 4,326 'real-world specimens' tested by Quest for AB 42/40, p-tau217 and ApoE4 values. The model and cut points categorized these specimens as having 42% high likelihood, 51% low likelihood, and 7% indeterminant likelihood for PET positivity. 'As the population ages and new therapies emerge, our new AD-Detect test will help fill the need for scalable, high-volume solutions that broaden access to robust and affordable evaluation of AD,' said study co-author Michael Racke, MD, a board-certified neurologist and Medical Director of Neurology at Quest Diagnostics. 'Our new test fulfills acceptable performance criteria set forth by the CEOi. We believe it will give providers greater confidence to move patients with a high likelihood score for AD more quickly on the path to treatment and potentially prevent the use of PET and lumbar puncture in patients whose blood values strongly indicate they do not have AD.' While amyloid PET imaging and cerebral spinal fluid testing are established methods for aiding the diagnosis of AD, they are significantly more expensive, invasive and specialist-dependent than blood-based tests. The study's strengths included significant ethnic diversity in the population (over 50% Hispanic) while limitations included using a predictive model that did not evaluate performance of the biomarkers in the context of non-AD causes of dementia. The study adds to a growing body of research on the Quest AD-Detect test portfolio, including studies published in the Journal of Investigative Medicine, Frontiers in Neurology and Alzheimer's & Dementia. Broadening access to quality AD assessment With the exception of New York, physicians in the United States may now order the test.1 Patients with a physician's order can provide a blood draw for testing through Quest's network of patient sites. Quest maintains approximately 8,000 patient access points, including an extensive patient service center network of approximately 2,000 locations in the U.S., as well as phlebotomists in physician offices and mobile phlebotomy services. Specimens will be transported for testing to Quest's state-of-the-art laboratory in San Juan Capistrano, California. Nearly 7 million Americans have Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. Approximately 12-18% of adults over the age of sixty are living with mild cognitive impairment, a potential sign of AD. Seventy-seven percent of physicians say new therapies will transform Alzheimer's into a chronic, manageable disease, and 94% of physicians say blood tests would be more cost effective for the healthcare system compared to more invasive methods of detection (e.g., lumbar puncture, imaging studies) according to a special report from Quest. Quest is committed to developing innovative advanced diagnostics to aid in evaluating AD and other brain diseases. For more information, visit About Quest Diagnostics Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world.
Associated Press
07-04-2025
- Health
- Associated Press
Delve Bio to Present on Metagenomic Next Generation Sequencing (mNGS) at the American Academy of Neurology 2025 Annual Meeting
Delve Bio, a pioneer in metagenomic next-generation sequencing (mNGS) for infectious diseases, will share data about its groundbreaking mNGS test, Delve Detect, at the 2025 American Academy of Neurology Annual Meeting today in San Diego. With the ability to identify more than 68,000 pathogens with a single test, Delve's mNGS technology delivers greater diagnostic yield over conventional methods of diagnosing meningitis and encephalitis. 'Diagnosing meningitis and encephalitis has historically required running test after test as physicians try to determine which pathogen is causing a patient's infection. In more than half of those cases, the cause is never found,' said Steve Miller, M.D., Ph.D., chief medical officer at Delve Bio. 'By using a metagenomic test, clinicians can detect viruses, bacteria, parasites, and fungi in just one test. It's an approach with more than seven years of real world evidence behind it showing mNGS outperforms traditional testing methods by over 20%, helping solve complex cases faster.' At this year's AAN Annual Meeting, Delve is presenting its mNGS assay and the technology behind Delve Detect. The backbone of Delve's mNGS platform is Delve Decide, which enables sequence matching of DNA and RNA to a curated database of over 68,000 pathogens through robust bioinformatic analysis, validated QC metrics, dynamic filtering, and visualization of high-quality reads; the results receive expert clinical interpretation to deliver comprehensive microbial analysis impossible through conventional testing. The strength of Delve's approach has been demonstrated through data from more than 4,800 patients tested at the University of California San Francisco (UCSF) over seven years – the largest study of its kind. The study found mNGS identified more pathogens than all other traditional methods (culture, antigen testing, PCR, and serology) combined. Published in Nature Medicine, the data showed mNGS detected pathogens in 14.4% of samples, representing 437 unique pathogen species, including DNA and RNA viruses, bacteria, fungi, and parasites. Among a subset of more than 1,000 patients treated at UCSF, 21.8% (48 of 220) of infections were identified by mNGS alone. Delve Detect is the company's flagship testing service, providing comprehensive test results with a 48-hour turnaround time after sample receipt and access to Delve's Clinical Microbial Sequencing Board, an on-call team of infectious disease experts to review results in clinical context. Delve Detect was built on technology developed at UCSF, which is exclusively licensed to Delve Bio. About Delve Bio, Inc. Delve Bio is a metagenomic next-generation sequencing (mNGS) company that empowers laboratories and clinicians with the insights they need to confidently diagnose routine and rare infectious diseases, thereby minimizing the impact of harmful pathogens on humanity. By leveraging its unbiased, pathogen-agnostic mNGS platform, Delve Bio is able to identify a wide range of pathogens with a single test. Founded by world leaders in genomics and infectious disease Drs. Charles Chiu, Joe DeRisi, Michael Wilson, Pardis Sabeti, and Matthew Meyerson, the company is backed by top institutional investors including Perceptive Xontogeny Venture Fund II, Section 32, and GV, along with leading individual investors. For more information, visit Amy Wong Senior Director of Marketing and Business Development, Delve Bio Media 42 North for Delve Bio INDUSTRY KEYWORD: HEALTH INFECTIOUS DISEASES NEUROLOGY CLINICAL TRIALS RESEARCH SCIENCE SOURCE: Delve Bio, Inc. Copyright Business Wire 2025. PUB: 04/07/2025 07:27 AM/DISC: 04/07/2025 07:26 AM
Yahoo
04-04-2025
- Health
- Yahoo
Lundbeck to present positive pipeline data at American Academy of Neurology (AAN) Annual Meeting
VALBY, Denmark, April 4, 2025 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) will present positive interim results from the open-label extension of the PACIFIC trial investigating bexicaserin, in addition to new analyses from clinical trials and real-world data with eptinezumab. H. Lundbeck A/S (Lundbeck) today announced that recent pipeline data will be presented at the 2025 AAN Annual Meeting in San Diego, U.S. The data includes an oral presentation of the six-month results from the open-label extension (OLE) of the Phase 1b/2a PACIFIC trial of bexicaserin, a novel treatment under development for seizures associated with Developmental and Epileptic Encephalopathies (DEEs).1 DEEs are the most severe group of epilepsies characterized by drug-resistant seizures, and developmental slowing or regression.2 "DEEs can be caused by a range of acquired, syndromal, and genetic etiologies, with more than 900 genes implicated. However, only a few subtypes currently have approved therapies, leaving many patients in need. The DEE-inclusive PACIFIC trial and six-month OLE data indicate that bexicaserin may be able to help address this unmet need across multiple DEE types, and highlights Lundbeck's expanding commitment to the neuro-rare space. We look forward to engaging with the global neuroscience community at AAN to discuss the data and potential of bexicaserin to support patients, caregivers and healthcare professionals in the management of DEEs," said Johan Luthman, EVP and Head of Research & Development at Lundbeck. The OLE included patients who successfully completed the PACIFIC trial3 and was designed to evaluate the long-term safety (up to 52 weeks), tolerability, and efficacy of bexicaserin in a cohort of participants with DEEs who were newly exposed to bexicaserin for at least 6 months.1 The OLE interim analysis showed that bexicaserin continues to exhibit a favourable safety and tolerability profile at six months, consistent with the safety profile observed during the PACIFIC trial. All bexicaserin treatment-naive patients (n=9) successfully transitioned from placebo to bexicaserin, reinforcing the tolerability of bexicaserin in an inclusive DEE population. In this placebo-bexicaserin switch population, a 57.3% reduction in countable motor seizures and 61.2% reduction in total seizures was observed, consistent with the response in non-naive participants at 6 months (n=32).* Moreover, more than half of patients newly exposed to bexicaserin (n=5/9) experienced a ≥50% reduction from baseline in countable motor seizures.1* In addition, Lundbeck will present recent post-hoc analyses and real-world data for eptinezumab investigating meaningful endpoints, such as good days per month†, and sustained treatment response. Lundbeck remains focused on raising the bar around preventive treatment expectations in migraine and increasing the understanding of the holistic impact of migraine on quality of life. *As compared to baseline at entry into PACIFIC study. †As reported by trial patients based on individual migraine experience Details of Lundbeck presentations at AAN 2025: Bexicaserin Oral Presentation Monday, April 7, Session S20, 4:18 – 4:30pm PT Title: Safety, Tolerability, and Efficacy of Bexicaserin in a Cohort of Participants with Developmental and Epileptic Encephalopathies: Interim Results of a Phase 1b/2a PACIFIC Study Open-Label Extension Eptinezumab Poster Presentations: Title: Long-term Maintenance of ≥50% and ≥75% Migraine Response With Eptinezumab in Patients With High-frequency Episodic Migraine and Chronic Migraine and 2-4 Prior Migraine Preventive Treatment Failures4 I Poster number: P12.005 Title: Patient-reported Impact of ≥75% Increase in Good Days/Month on Migraine Symptoms, Quality of Life, and Brain Fog: Real-world Study of Adults With Chronic Migraine Treated With Eptinezumab5 I Poster number: P12.010 Title: Long-term Reductions in Monthly Headache Days With Eptinezumab Treatment in Adults With Chronic Migraine: Results From the PREVAIL Study6 I Poster number: P12.003 About Bexicaserin Bexicaserin (LP352) is an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist with no observed impact on 5-HT2B and 5-HT2A receptor subtypes. It is being evaluated in a global Phase III clinical program (the DEEp Program). The FDA has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age and older. Bexicaserin is an investigational compound that is not approved for marketing by any regulatory authority worldwide. The PACIFIC trial was a randomised, double-blind, placebo-controlled, DEE-inclusive trial (NCT05364021) in 52 participants with Dravet syndrome, Lennox-Gastaut syndrome, or DEE Other, who had ≥4 countable motor seizures during the 28-day baseline period, and who were on a stable regimen of 1 to 4 concomitant antiseizure medications.3 About eptinezumab (Vyepti®) Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was purposefully developed for IV administration. The efficacy and safety of eptinezumab 100 mg and 300 mg was investigated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), where eptinezumab met its primary endpoint of decrease in mean monthly migraine days (MMD) over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program observed a treatment benefit over placebo that was observed for both doses of eptinezumab as early as day 1 post-infusion. The safety of eptinezumab was evaluated in more than 2,000 adult patients with migraine who received at least one dose of eptinezumab. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. Approximately 8% of patients on 300 mg, 6% of patients on 100 mg and 6% of patients on placebo in PROMISE-1 and PROMISE-2 experienced nasopharyngitis. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions. Eptinezumab was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Medicines Agency (EMA) for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in the U.S. market, as well as in more than 30 markets worldwide. Contacts Marie Petterson Jens Høyer Media Relations Lead, Corp. Communication Vice President, Head of Investor Relations MEEP@ JSHR@ +45 29 82 21 82 +45 30 83 45 01Palle Holm OlesenVice President, Investor RelationsPALO@ 30 83 24 26 About H. Lundbeck A/S Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has approximately 5,500 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site and connect with us via LinkedIn. References: 1. American Academy of Neurology Annual Meeting 2025. Safety, Tolerability, and Efficacy of Bexicaserin in a Cohort of Participants with Developmental and Epileptic Encephalopathies: Interim Results of a Phase 1b/2a PACIFIC Study Open-Label Extension. 2. Sheffer I, et al. Epilepsia. 2025 Feb 10.1111/epi.18265. 3. Kaye R, et al. Efficacy and safety of bexicaserin (LP352) in adolescent and adult participants with developmental and epileptic encephalopathies: Results of the phase 1b/2a PACIFIC study. Presented at the Annual Meeting of the American Academy of Neurology; April 13-18, 2024 4. Ailani J, et al. Poster Presentation. American Academy of Neurology Annual Meeting 2025. 5. Argoff C, et al. Poster presentation. American Academy of Neurology Annual Meeting 2025. 6. Starling A, et al. Poster Presentation. American Academy of Neurology Annual Meeting 2025. CONTACT: H. Lundbeck A/SOttiliavej 9, 2500 Valby, Denmark+45 3630 1311info@ This information was brought to you by Cision The following files are available for download: Lundbeck AAN_ Final View original content: SOURCE H. Lundbeck A/S Sign in to access your portfolio
Yahoo
03-04-2025
- Business
- Yahoo
Annexon Highlights Leadership in Advancing Clinical Research and Education for Guillain-Barré Syndrome (GBS) at American Academy of Neurology (AAN) 2025 Annual Meeting
Oral Plenary Presentation on Tuesday, April 8 Features Phase 3 Data for ANX005, the First Potential Targeted Therapy for GBS, Showing Rapid and Durable Benefit Across Clinical Measures and Time Points Educational Symposium Focuses on Advancing GBS Care and Role of Classical Complement Pathway New Disease Education Campaign 'Move GBS Forward' Draws Attention to Life-altering Physical and Mental Impact of GBS BRISBANE, Calif., April 03, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlights the company's leadership in advancing clinical research and education for GBS at the AAN Annual Meeting taking place April 5–9, 2025, in San Diego, California. Highlighted activities at the conference include: An oral plenary session, part of the 'Clinical Trials Plenary' session, for the first placebo-controlled Phase 3 trial in GBS, 'A Phase 3 Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ANX005 in Patients with Guillain-Barré Syndrome (GBS)'. Presenter: Jeff Allen, MD, Professor of Neurology at the University of Minnesota Program Number: PL5.006 Date/Time: Tuesday, April 8, 10:30-10:45 a.m. Pacific Time An educational symposium, 'Advancing GBS Care: Latest Insights into the role of classical complement pathway in GBS,' where experts will discuss the risks associated with GBS, current state of patient care and need for new targeted treatments. Presenters: Jeff Allen, MD, Professor of Neurology at the University of Minnesota; Avni Kapadia, MD, Assistant Professor of Neurology at Baylor College of Medicine; and Nick Silvestri, MD, FAAN, Professor of Neurology, Associate Dean at University of Buffalo Date/Time: Tuesday, April 8, 6:00-7:00 p.m. Pacific Time At AAN (Booth #2133), Annexon is launching a new disease education campaign for healthcare professionals called 'Move GBS Forward,' which is designed to advance awareness and understanding of the sudden and long-term impact of GBS so as to encourage prompt diagnosis and care. GBS is a neuromuscular emergency that affects at least 150,000 people worldwide each year, with no FDA-approved therapies. This rare autoimmune disease is characterized by rapidly progressing and severe weakness that can lead to complete paralysis, often requiring intensive care and mechanical ventilation. ANX005 is a first-in-kind monoclonal antibody designed to block C1q, the initiating molecule of the classical complement cascade, with a single infusion to halt ongoing neuroinflammation and nerve damage in the acute phase of GBS to improve and expedite overall recovery. About Annexon Annexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neurodegeneration as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement's potent inflammatory pathway that when misdirected can lead to tissue damage and loss. By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade in disease before it starts. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. Annexon's mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'design,' 'due,' 'estimate,' 'expect,' 'goal,' 'intend,' 'may,' 'objective,' 'plan,' 'positioned,' 'potential,' 'predict,' 'seek,' 'should,' 'target,' 'will,' 'would' and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the ability of ANX005 to block C1q activity within a single infusion; the potential therapeutic benefit of ANX005; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company's portfolio. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company's history of net operating losses; the company's ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company's product candidates; the effects of public health crises on the company's clinical programs and business operations; the company's ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company's product candidates; the company's reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company's ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled 'Risk Factors' contained in the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company's other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Joyce AllaireLifeSci Advisorsjallaire@ Media Contact: Sheryl SeapyReal Chemistry949-903-4750sseapy@
