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Neurology

Sage’s Pipeline Prospects Narrow Further As Dalzanemdor Fails In Huntington’s

Sage will end development for dalzanemdor after it failed in a Phase II Huntington’s disease trial, leaving the company with one commercial drug and three early-stage assets.

When It Comes To Stroke Care, Spanish Start-Up Embodies ‘Time Is Brain’ Medical Principle To Save Neurons And Lives

Medtech Insight spoke with executives from Spanish medtech firm Time is Brain about their wearable device that monitors stroke victims in real time, potentially saving lives.

Gohibic For SARS-CoV-2-Induced ARDS Among Eight New Drugs To Win EMA Nod

Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.

Leqembi Secures EMA Thumbs Up For Narrower Indication

After an initial rejection, the European Medicines Agency now says that Eisai/Biogen’s Alzheimer’s disease drug should be approved, albeit with a recommendation for initial generic screening and ongoing safety scans.

Trace Launches With $101m To Pursue ALS Drug Based On Genomic Insights

Trace Neuroscience will take its antisense oligonucleotide that restores UNC13A protein production through proper mRNA splicing into the clinic in early 2026.

EU Crunch Time For Kizfizo, Sipavibart, Coacillium And Eight Other Products

The European Medicines Agency’s human medicines committee is meeting this week due to decide whether or not to back pan-EU marketing approval for a number of new drugs.

EMA's Final Call On Alzheimer's Drug Leqembi Imminent

Patient representatives are due to have their say today at a high-stakes meeting at the European Medicines Agency, which, after re-examining its previous rejection of Leqembi, is expected to deliver its final decision on whether the drug should be approved for marketing in the EU.

Octave Bioscience’s Multi-Biomarker Test Provides Key Insights To Predict Multiple Sclerosis Disease State

Octave Bioscience’s CEO Doug Biehn sat down with Medtech Insight at HLTH to talk about the company’s plans for expanding their multivariate biomarker blood test for MS analysis and development of a diagnostic for Parkinson’s disease.

Eisai Cuts US Leqembi Sales Forecast But Japan, China Exceed Expectations

Eisai/Biogen’s Alzheimer’s disease medicine Leqembi has been a challenge to launch, but while access to pre-treatment testing has improved, infusion center capacity is impacting US sales.

Sarepta’s Elevidys Sales Surge, But Next-Gen DMD Drug Platform Discontinued

Q3 sales of DMD gene therapy Elevidys beat forecasts, but the company declined to raise Q4 and 2025 guidance. It plans to file a second gene therapy with the US FDA next year.