Author: rachael_acnr

FDA grants priority review to oral fenebrutinib for RMS and PPMS

Posted on October 7, 2026 by - Multiple Sclerosis

The US Food and Drug Administration (FDA) has granted priority review to Roche’s fenebrutinib, an investigational oral treatment for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The FDA aims to complete its review within six months, with a decision expected by spring 2027.

Fenebrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor designed to target both acute inflammation associated with MS relapses and chronic inflammation in the brain that is thought to contribute to disability progression. It can cross the blood-brain barrier and acts on B cells and microglia.

The application is supported by three Phase III studies. In the FENhance 1 and FENhance 2 trials, fenebrutinib reduced annualised relapse rates by 51.1% and 58.5%, respectively, compared with teriflunomide over 96 weeks. The treatment also reduced active and chronic brain lesions, while measures of disability progression showed trends favouring fenebrutinib.

In the FENtrepid study in PPMS, fenebrutinib met its primary endpoint of non-inferiority to Ocrevus (ocrelizumab) in reducing disability progression. Fenebrutinib was associated with a numerical 12% reduction in the risk of confirmed disability progression compared with Ocrevus, although the study was not designed to demonstrate superiority.

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Serious adverse event rates were similar between fenebrutinib and comparators in two of the three pivotal studies, although they were higher with fenebrutinib than teriflunomide in FENhance 2. Liver enzyme elevations were more frequent with fenebrutinib than Ocrevus in FENtrepid.

If approved, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral therapy approved in the US for both RMS and PPMS.

This news item has been summarised using AI and checked by humans before publication.

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Sources

Roche: Fenebrutinib FDA priority review announcement, 30 September 2026

New MRI test speeds up MS diagnosis and avoids painful lumbar punctures

Posted on October 6, 2026 by - Multiple Sclerosis

A new MRI-based test for multiple sclerosis (MS) has been successfully introduced into an NHS diagnostic pathway, reducing the need for painful lumbar punctures while helping patients receive a diagnosis more quickly.

In 2024, the McDonald diagnostic criteria for MS were revised to include the MRI marker central vein sign (CVS), in which a small vein visibly runs through the centre of a lesion. This feature is considered specific to MS and can help distinguish it from other conditions with overlapping symptoms. Despite its inclusion in the criteria, the CVS assessment has remained underutilised in clinical practice.

Researchers at the University of Nottingham developed an approach using a T2*-weighted MRI scan to identify the CVS. The additional imaging takes around six minutes and can be performed using clinical MRI scanners.

MS causes lesions or areas of scarring in the brain and spinal cord, but diagnosis can be difficult because symptoms vary considerably between individuals. Patients suspected of having MS have traditionally undergone MRI followed, in some cases, by a lumbar puncture to analyse spinal fluid. Lumbar punctures can cause headaches, back pain and other complications.

The Nottingham team incorporated the CVS into a fast-track NHS diagnostic pathway, arranging the MRI before the patient’s first clinic appointment. Among patients subsequently diagnosed with MS, the average time from referral to diagnosis was 2.9 months through the fast-track pathway, compared with 5.6 months through usual outpatient care. This represented an average saving of 83 days.

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No patients diagnosed through the fast-track pathway required a lumbar puncture. The researchers also estimated an average cost of £707 per patient, compared with £999 through the usual outpatient pathway, a saving of approximately £292 per patient.

Dr Christopher Gilmartin, first author of the project, said the central vein sign could allow clinicians to make an accurate diagnosis without invasive lumbar punctures and reduce unnecessary delays.

Professor Nikos Evangelou, Professor of Clinical Neurology, who has worked on the approach for two decades, said the team was encouraging other UK hospitals to adopt the MRI test.

The findings have been published in Neurology: Clinical Practice.

This news item has been summarised using AI and checked by humans before publication.

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Sources

News – New diagnostic test for MS is less painful for patients, leads to a quicker diagnosis and cost savings for the NHS – University of Nottingham

Rapid blood test for stroke receives CE mark

Posted on September 29, 2026 by - Stroke

UpFront Diagnostics has announced CE marking for LVOne, a rapid blood-based test designed to support the identification of severe stroke before patients reach hospital. The Cambridge-based company describes LVOne as the first rapid blood test for stroke to achieve CE certification, enabling its commercial launch across the European Union.

LVOne is intended primarily to help identify large vessel occlusion (LVO), a form of ischaemic stroke in which rapid access to mechanical thrombectomy can be critical. The point-of-care test uses a finger-prick blood sample and measures D-dimer and glial fibrillary acidic protein (GFAP), biomarkers associated with clot formation and intracerebral haemorrhage respectively. Results are available within 10 minutes.

The technology is designed for use by paramedics and other emergency teams, potentially allowing patients suspected of having an LVO to be identified earlier and transported to an appropriate specialist stroke centre.

A 2026 study involving samples from 210 patients with suspected stroke reported 75% sensitivity, 92% specificity and a 97% negative predictive value for LVO detection using LVOne alongside clinical assessment. An updated version also demonstrated improved identification of intracerebral haemorrhage. The researchers noted that prospective validation in real-world pre-hospital settings remains necessary.

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LVOne had previously received UKCA marking and is being deployed with the London Ambulance Service. The company says the CE mark will now allow the technology to be introduced more widely in European stroke pathways.

Gonzalo Ladreda, CEO and co-founder of UpFront Diagnostics, said the regulatory milestone would help accelerate the company’s aim of reducing delays in stroke diagnosis.

The CE marking represents a further step towards incorporating biomarker-based testing into pre-hospital stroke triage, where rapid identification of patients requiring specialist intervention could help shorten the time to definitive treatment.

This news item has been summarised using AI and checked by humans before publication.

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Sources

UpFront Diagnostics

Ghosh A et al. Prehospital Detection of Large Vessel Occlusion and Intracerebral Hemorrhage Using a Dual-Biomarker Point-of-Care Test. Stroke: Vascular and Interventional Neurology

Transient ischaemic attack associated with increased risk of dementia

Posted on September 29, 2026 by - Dementia, Stroke

Rates of dementia three times higher than rates of having a stroke

Highlights:

  • Having a transient ischaemic attack is associated with an increased risk of dementia.
  • A transient ischaemic attack is when blood flow stops to a part of the brain for a short time causing symptoms that go away within a day with no stroke visible on brain scans.
  • The study does not prove that a transient ischaemic attack causes dementia, it only shows an association.
  • Over an average of seven years, people with a transient ischaemic attack had a 34% higher risk of dementia than people who did not have one.
  • The study also found after a transient ischaemic attack, dementia rates were three times higher than stroke rates.
  • Researchers say prevention strategies after a transient ischaemic attack should go beyond stroke prevention and include efforts to reduce the risk of dementia.

Having a transient ischaemic attack (TIA) is associated with an increased risk of developing dementia, according to a new study published September 23, 2026, in  Neurology®, the medical journal of the American Academy of Neurology. The study does not prove that a transient ischaemic attack causes dementia, it only shows an association.

A TIA is when blood flow stops to a part of the brain for a short time, causing stroke-like symptoms that go away within a day with no stroke visible on brain scans. It can be a precursor to a full stroke.

“After a transient ischaemic attack, there is a well-established increased risk of stroke, but less is known about the risk of dementia,” said study author Raed A. Joundi, MD, DPhil, of McMaster University and the Population Health Research Institute in Hamilton, Canada. “In our study, over an average of seven years, one in five people who had a TIA developed dementia.”

For the study, researchers looked at two decades of health data in Ontario to identify 113,081 people with an average age of 70 who had a first transient ischaemic attack and no prior history of dementia. These participants were matched for age, sex, and health factors such as diabetes and blood pressure to people who did not have a stroke or dementia. They were also matched separately to people who had a first stroke.

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Participants were followed for an average of seven years. During this time, 19% of people with TIA had a new diagnosis of dementia, compared to 15% of those without stroke or TIA and 20% of those with a stroke. Of people with TIA, there were 2.71 new cases of dementia per 100 person years and of people without TIA, there were 2.03 cases per 100 person years. Person-years represent both the number of people in the study and the amount of time each person spent in the study.

Researchers found the risk of developing dementia was highest in the first year after a TIA. After matching for age, sex, urban or rural residence, vascular risk factors like high blood pressure and diabetes, people with transient ischaemic attack had a 75% increased risk of dementia in the first year compared to those without stroke. Researchers say the risk declined but remained elevated over 20 years, with an overall increased risk of 34%.

When compared to people who had a stroke, people who had a transient ischaemic attack had a 33% lower risk of dementia in the first year, but after five years, the risk was similar.

People who had a TIA were three times more likely to develop dementia over the entire follow-up period than to have a stroke.

“Transient ischaemic attack is associated with a large and sustained increase in dementia risk,” said Joundi. “In addition, dementia occurs far more frequently after a TIA than having a stroke. This highlights that prevention strategies after a TIA should go beyond stroke prevention and consider dementia as a major long-term complication.”

A limitation of the study was that researchers did not have detailed brain imaging to determine if people had hidden disease at the start of or during the study.

The analysis for this study was done at ICES, a health research institute in Ontario.

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Source:
https://www.aan.com/PressRoom/Home/PressRelease/5368?

FDA approves tavapadon for Parkinson’s disease

Posted on September 28, 2026 by - Movement Disorders, Parkinson’s Disease

The US Food and Drug Administration (FDA) has approved tavapadon (Juvmo) for the treatment of adults with Parkinson’s disease, introducing a new once-daily oral treatment that selectively targets dopamine D1/D5 receptors.

The FDA approved tavapadon on 25 September. The drug can be used in early Parkinson’s disease and alongside levodopa in patients experiencing motor fluctuations. It is the first selective D1/D5 dopamine receptor agonist approved in the US.

Approval was supported by the phase 3 TEMPO clinical trial programme. In the TEMPO-1 study, patients with early Parkinson’s disease receiving tavapadon showed significant improvements in activities of daily living and motor function compared with placebo after 26 weeks.

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The TEMPO-3 trial evaluated tavapadon as an adjunct to levodopa in 507 patients experiencing motor fluctuations. Tavapadon increased daily ‘on’ time without troublesome dyskinesia by 1.7 hours from baseline, compared with 0.6 hours with placebo. Daily ‘off’ time decreased by 1.88 hours with tavapadon compared with 0.93 hours with placebo.

Adverse events were more frequent with tavapadon than placebo in TEMPO-3, occurring in 71.7% and 55.1% of participants respectively, although most were non-serious and mild to moderate. Common adverse events included nausea, dyskinesia and dizziness.

Unlike established dopamine agonists that primarily target D2/D3 receptors, tavapadon is a selective D1/D5 receptor partial agonist. The phase 3 trials did not directly compare tavapadon with existing dopamine agonists or other adjunctive Parkinson’s therapies, and longer-term efficacy and safety continue to be evaluated.

AbbVie expects tavapadon to become available in the US in October 2026.

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This news item has been summarised using AI and checked by humans before publication.

Sources

U.S. FDA Approves AbbVie’s JUVMO™ (tavapadon) for Parkinson’s Disease

AbbVie, US FDA approves Juvmo (tavapadon) for Parkinson’s disease

JAMA Neurology, Fixed-Dose Tavapadon for Early Parkinson Disease: A Randomized Clinical Trial

JAMA Neurology, Tavapadon as Adjunctive Treatment for Parkinson Disease: The TEMPO-3 Randomized Clinical Trial

NHS pilots rapid genomic test to transform brain tumour diagnosis

Posted on September 28, 2026 by - Brain tumours, Industry News

Thousands of patients with suspected brain tumours could receive a definitive diagnosis within days rather than weeks under an NHS England pilot of rapid genomic testing being expanded across specialist centres.

The technology rapidly analyses DNA from a small tumour sample collected during biopsy or surgery, helping clinicians identify the precise tumour type and potentially allowing appropriate treatment, including radiotherapy and chemotherapy, to begin sooner.

In some operations where the tumour type is not yet known, testing can provide information to surgeons in under two hours while surgery is still taking place. This could help surgical teams decide how much tumour tissue can safely be removed while protecting healthy brain tissue.

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The approach has already been piloted in Nottingham and Birmingham. During a recent operation at Nottingham University Hospitals, sequencing took around 20 minutes and an initial tumour classification was returned to the surgical team less than two hours after the sample reached the laboratory. Further analysis provided a fuller molecular diagnosis within days.

NHS England will initially introduce the technology at five specialist centres: University Hospitals Birmingham, Nottingham University Hospitals, Great Ormond Street Hospital for Children, King’s College Hospital and Newcastle Hospitals. Genomic laboratory sites in Bristol, Oxford, Leeds and Manchester are expected to join during a second phase.

The programme is supported by more than £2 million of NHS England investment over two years through the Brain Cancer NHS Genomic Network of Excellence.

Professor Dame Sue Hill, Chief Scientific Officer for England, said the aim was to build evidence for rapid genomic testing to become part of routine NHS care, giving patients more equal access to faster and more precise diagnosis.

Around 13,000 people in the UK are diagnosed with a primary brain tumour each year. Faster molecular diagnosis could also allow eligible patients to access clinical trials sooner.

This news item has been summarised using AI and checked by humans before publication.

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Continuous neuroimaging reveals hidden events

Posted on September 21, 2026 by - Industry News, Research

Researchers at Johns Hopkins Medicine have developed a miniaturised, cloud‑connected microscope that enables continuous neuroimaging for more than 24 hours in freely moving mouse models, overcoming a long‑standing limitation in preclinical neuroscience research. The device, CloudScope, streams live imaging data remotely, allowing investigators to observe physiological changes as neurological disease evolves over extended periods.

The team reports that this extended‑window approach captures dynamic changes in neuronal activity, blood flow, vessel remodelling, oxygenation and cellular behaviour that conventional short‑window imaging would miss. Crucially, they observed spontaneous seizures occurring several hours after a drug‑induced event, revealing clinically relevant phenomena that fall outside typical laboratory observation periods.

In parallel tumour studies, researchers tracked individual cancer cell behaviour and microenvironment changes as disease progressed, offering a more granular view of tumour dynamics than standard imaging allows. The authors describe this continuous‑monitoring paradigm as “neurosurveillance”, proposing it as a new framework for studying brain function and disease progression over realistic biological timescales.

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The group also demonstrated an early application of AI, training a model to predict levels of animal mobility based solely on neuronal activity recorded by the device — pointing toward future opportunities to link behaviour and brain activity in disease models such as stroke or Parkinson’s disease.

The research appears in Nature Methods and was supported by the National Cancer Institute and the National Institute of Neurological Disorders and Stroke.

Credit: Cheryl Famulare and Arvind Pathak This stylized image illustrates the trajectories of brain cancer cells that were acquired in vivo over a period of 72 hours using the CloudScope. These cell trajectories are represented as colored trails, which are superimposed on the corresponding vasculature, depicted in red. The world map in the background highlights the global accessibility of this cloud-based imaging platform.

Credit: Cheryl Famulare and Arvind Pathak 

This stylised image illustrates the trajectories of brain cancer cells that were acquired in vivo over a period of 72 hours using the CloudScope. These cell trajectories are represented as colored trails, which are superimposed on the corresponding vasculature, depicted in red. The world map in the background highlights the global accessibility of this cloud-based imaging platform.

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AI tool helps radiologists detect 39% more brain aneurysm cases in real-world study

Posted on September 17, 2026 by - Uncategorized

A new prospective study published in the Journal of the American College of Radiology reports that an FDA-cleared artificial intelligence tool can meaningfully enhance the detection of intracranial aneurysms when used alongside radiologists. The evaluation, carried out at Northwell Health, assessed the algorithm across 3,856 CT angiography examinations performed in routine clinical practice, providing real-world evidence of its potential value in neurovascular imaging.

Researchers found that radiologists and the AI tool agreed in more than 96% of cases, with the algorithm identifying 55 true-positive aneurysms that were not reported by radiologists. This represented a 39% relative increase in detection compared with radiologist-only interpretation. The AI system showed higher sensitivity than radiologists alone, detecting more aneurysms that were truly present, including many of the smallest lesions. The authors note that early identification of small aneurysms may support risk assessment, surveillance and treatment before rupture occurs.

The study was conducted in a shadow-mode design, meaning AI processed scans in parallel but did not influence patient care. Independent expert neuroradiologists reviewed discrepancies to establish the correct findings. Both radiologists and AI missed some aneurysms, but each detected cases the other did not, highlighting their complementary strengths.

Performance varied across care settings. The inpatient environment showed the most favourable results, with 18 additional aneurysms detected and only seven false positives. Emergency department performance was also positive, while outpatient gains were modest, with more false-positive than true-positive findings.

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The authors emphasise the importance of evaluating AI tools in real-world clinical environments and monitoring performance after implementation to understand how they support physician decision-making and patient care .

This article was created with AI assistance and reviewed by an ACNR editor.

Sources

AI Helps Radiologists Detect 39% More Brain Aneurysm Cases in Real-World Study

Journal of the American College of Radiology

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Nusinersen accepted in Scotland for pre symptomatic SMA

Posted on September 10, 2026 by - Uncategorized

The Scottish Medicines Consortium has accepted nusinersen for restricted use within NHS Scotland for babies with genetically confirmed 5q spinal muscular atrophy before symptoms appear. The decision, published in August 2026, provides clinicians with an additional early treatment option for infants identified through newborn screening or targeted genetic testing.

The SMC advice confirms that nusinersen can be used in pre symptomatic infants with either two or three copies of the SMN2 gene. Evidence reviewed by the committee showed that early treatment was associated with substantially improved outcomes compared with historical cohorts. Most infants treated before symptom onset achieved major motor milestones, including sitting and walking independently, and the majority did not require respiratory support during follow up. The committee concluded that initiating therapy at the earliest possible stage offered clear clinical benefit.

With this decision, all three licensed SMA treatments are now available in Scotland for babies before symptoms develop. The SMC noted that early access enables clinicians and families to make informed choices about therapy based on clinical characteristics, family preference and the evolving evidence base. The advice also highlighted the importance of newborn screening pathways in ensuring timely diagnosis and referral to specialist neuromuscular teams.

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Nusinersen will continue to be prescribed and monitored within specialist services, with ongoing assessment of clinical response. The SMC’s acceptance is expected to support more consistent access to early treatment and may contribute to improved long term outcomes for infants diagnosed through Scotland’s screening programme.

This news item was drafted with AI assistance and reviewed by ACNR’s editorial team.

Sources

https://www.scottishmedicines.org.uk

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HeBA study adds NeuraLight eye-movement biomarkers to track early brain changes

Posted on August 31, 2026 by - Industry News

The Healthy Brain Ageing (HeBA) initiative is integrating NeuraLight’s eye-movement biomarkers into its large European study investigating early changes associated with neurodegenerative disorders, with a particular focus on Parkinson’s disease. The collaboration will add a scalable measure of brain function to a programme involving nearly 13,000 adults aged 50 to 80.

HeBA operates across Germany, Austria, Spain and Luxembourg and is supported by The Michael J. Fox Foundation. The initiative aims to improve the identification of people at increased risk of developing Parkinson’s disease before a clinical diagnosis, including during the prodromal phase when symptoms may be absent or subtle.

NeuraLight’s technology uses a 10-minute eye-movement assessment to quantify aspects of brain function. Eye movements are controlled by distributed neural networks, and the company’s biomarkers are designed to measure changes in specific neural circuits, including those that may be affected during ageing and neurodegenerative disease.

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The biomarkers will be incorporated alongside the biological and clinical assessments already used by HeBA. Researchers hope the additional measurements will help identify and track subtle functional changes over time that may not yet be apparent through conventional clinical assessment.

The approach has previously been evaluated in a peer-reviewed study published in Pharmaceutical Medicine. That research assessed eye-movement biomarkers for monitoring Parkinson’s disease progression and reported sensitivity to change over a nine-month period.

HeBA recruits adults without a neurodegenerative diagnosis and uses online assessments to identify participants who may benefit from further investigation. Selected participants are offered in-person evaluation and prospective follow-up.

The collaboration could provide researchers with additional longitudinal data on how measurable brain function changes before and during the emergence of neurodegenerative disease, potentially supporting the development of earlier detection and monitoring approaches.

This news item has been summarised using AI and checked by humans before publication.

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Sources

https://www.businesswire.com/news/home/20260813008681/en/Landmark-International-Brain-Health-Initiative-Deploys-NeuraLights-Biomarkers-to-Quantify-Change-in-Brain-Function

https://ageinghealthy.eu/