Neurology Updates — August 2025


Neurology Updates — August 2025

August 2025 delivered practice-relevant neurology updates worldwide — fresh guideline shifts, pivotal trial readouts, new approvals, and high-impact AI/tools. Below is a concise, clinician-first roundup, capped with a focused deep dive on vorasidenib in IDH-mutant glioma. 🧠

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📋Clinical findings & guideline changes

Head-flat positioning before thrombectomy linked to better outcomes

Data suggest maintaining 0° head position pre-EVT improves stability and outcomes in LVO stroke candidates.

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ACC/AHA publish 2025 hypertension guideline (stroke-relevant)

New guideline emphasizes prevention, earlier treatment when needed, and individualized risk assessment.

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💊New drugs

Donanemab receives CHMP positive opinion for early Alzheimer’s

CHMP backs donanemab for early symptomatic AD; EC decision next for EU availability.

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FDA issues CRL for vatiquinone in Friedreich’s ataxia

Agency requests an additional adequate, well-controlled study before resubmission.

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Efgartigimod hits endpoint in seronegative gMG (ADAPT SERON)

Phase 3 topline shows clinically meaningful benefit across MuSK+, LRP4+, and triple-seronegative subgroups.

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CHMP positive opinion for Aqneursa (levacetylleucine) in NPC

Supports treatment of neurological manifestations in adults and children ≥6 years.

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🛠️New medical devices

FDA approves Genio hypoglossal nerve stimulator for OSA

PMA approval confirms neurostimulation option for moderate–severe OSA (AHI 15–65).

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🤖Specialty software & AI

FDA authorizes AI brain-mapping software for neurosurgery/epilepsy

Machine-learning platform enhances anatomical localization and mapping to guide resections and invasive monitoring.

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🎯Deep Dive — Vorasidenib (Voranigo) for IDH-mutant Grade 2 Glioma

CHMP recommends EU approval; targeted option to delay radiochemotherapy

Therapeutic options: Post-resection IDH-mutant grade 2 glioma care has been a balance between active surveillance and early radiochemotherapy (RT/TMZ) with long-term cognitive and systemic toxicity risks. A brain-penetrant, oral IDH1/2 inhibitor introduces a third path: targeted disease control while delaying RT/TMZ exposure. 🔄

Trial population & design: Phase 3 INDIGO enrolled adults with residual/non-enhancing IDH-mutant grade 2 glioma after surgery, randomized to vorasidenib vs placebo; primary endpoint PFS, key secondary endpoint time-to-next-intervention.

Efficacy: Median PFS 27.7 vs 11.1 months (HR 0.39); time-to-next-intervention HR 0.26 — demonstrating durable disease control and postponement of RT/TMZ.

Safety/monitoring: Grade ≥3 AEs 22.8% vs 13.5% (ALT/AST elevations most common); no treatment-related deaths. Practical points: baseline and periodic LFTs, MRI surveillance, dose holds/reductions as needed.

Clinical takeaway: Pending EC ratification, vorasidenib would be the first targeted oral therapy for this setting, enabling a “preserve cognition, delay toxicity” strategy within multidisciplinary neuro-oncology pathways. ✅

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Deep Dives in Neurology and Neuroscience Updates

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In partnership with Neurology Monthly — September 2025 September 2025 delivered major advances in neurology — from targeted glioma therapies and Alzheimer’s delivery innovations to AI-driven stroke triage and new insights into brain–computer interfaces. 🧠 📋Clinical & Guidelines NCCN adds Modeyso (dordaviprone) for H3 K27M diffuse midline glioma Now a Category 2A recommendation, marking the first systemic therapy in guidelines for this tumor. Read more 💊Drug Approvals & Pipeline FDA approves...

🧬 AMX0035 Shows Sustained Benefit in Wolfram Syndrome at 48 Weeks Amylyx Pharmaceuticals has reported positive long-term results from its Phase 2 HELIOS trial evaluating AMX0035 in individuals with Wolfram syndrome, a rare, progressive neurodegenerative disease. At 48 weeks, the treatment continued to demonstrate improvements or stabilization across multiple disease domains, suggesting durable therapeutic benefit. 🔍 Key Highlights Pancreatic Function: C-peptide response—a marker of residual...

💤 Oral Therapy AD109 Shows Promise in Treating Obstructive Sleep Apnea A recent phase 3 clinical trial has shown that AD109, an investigational oral therapy, significantly reduces the severity of obstructive sleep apnea (OSA) over a six-month period. The SynAIRgy study focused on adults with mild to severe OSA who were either intolerant of or declined CPAP therapy. 🔍 Key Findings Marked Reduction in AHI: Participants receiving AD109 experienced a 55.6% decrease in apnea-hypopnea index (AHI),...