Neuroscience Today — November 5, 2025

This week’s neuroscience update highlights major clinical milestones, new approvals, and innovative partnerships driving progress across biopharma.

In Today’s Newsletter

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🧠 Johnson & Johnson initiates Phase 3b EPIC study of IMAAVY™ in gMG [1] [US • 29 Oct 2025]

https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-first-head-to-head-study-comparing-imaavy-with-an-alternative-fcrn-blocker-in-generalized-myasthenia-gravis-gmg-at-aanem-annual-meeting

Context: First head-to-head trial in adults with generalized myasthenia gravis (gMG) comparing IMAAVY™ to efgartigimod. New data from pediatric Vibrance-MG study show sustained IgG reduction and functional improvements in gMG patients aged 12 and older.

Key Point: Study will include a treatment-switch arm; results will help physicians optimize gMG patient care.

Implication: Potential to solidify IMAAVY™ as the preferred FcRn blocker for gMG treatment.

💊 AstraZeneca’s gefurulimab meets primary endpoint in Phase III PREVAIL trial [2] [US • 30 Oct 2025]

https://www.astrazeneca.com/media-centre/press-releases/2025/positive-results-from-prevail-phase-iii-trial-at-aanem-mgfa-scientific-session.html

Context: Gefurulimab shows early and sustained improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores.

Key Point: Statistically significant results at week 26 compared to placebo, with early effects observed as early as week 1.

Implication: Gefurulimab could provide a new, self-administered treatment option for patients with anti-AChR+ gMG.

🏷️ Koselugo approved in EU for NF1-related plexiform neurofibromas [3] [EU • 28 Oct 2025]

https://www.astrazeneca.com/media-centre/press-releases/2025/koselugo-approved-in-the-eu-for-plexiform-neurofibromas-in-adults-with-neurofibromatosis-type-1.html

Context: Koselugo (selumetinib), an oral MEK inhibitor, is now approved for treating symptomatic, inoperable plexiform neurofibromas in adult patients with neurofibromatosis type 1 (NF1).

Key Point: Based on positive results from the KOMET Phase III trial.

Implication: Offers a new treatment option for adult patients, expanding Koselugo’s therapeutic use beyond pediatric patients.

🤝 Teva launches ‘The Other TD’ campaign for Tardive Dyskinesia [4] [US • 3 Nov 2025]

https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Teva-Kicks-Off-The-Other-TD-to-Raise-Awareness-of-Tardive-Dyskinesia-TD-with-Support-from-Pro-Football-Hall-of-Famer-Terrell-Davis/default.aspx

Context: Teva collaborates with Terrell Davis to raise awareness about tardive dyskinesia (TD), a movement disorder linked to psychiatric medications.

Key Point: Focus on increasing recognition of symptoms and encouraging conversations with healthcare providers.

Implication: Campaign aims to address underdiagnosis and improve treatment access for affected individuals.

🔬 Roche invests in Manifold Bio’s BBB technology [5] [US • 3 Nov 2025]

https://www.biospace.com/drug-development/roche-piles-55m-into-blood-brain-barrier-tech-with-manifold

Context: Roche partners with Manifold Bio to develop blood-brain barrier (BBB) shuttles for CNS diseases, investing $55M.

Key Point: Manifold’s AI-driven technology will help develop BBB shuttles to improve drug delivery to the brain.

Implication: Could enhance the effectiveness of treatments for neurodegenerative diseases like Alzheimer’s.

🧬 SK Biopharm partners with Interon Labs for autism therapy [6] [US • 3 Nov 2025]

https://www.koreabiomed.com/news/articleViewAmp.html?idxno=29484

Context: SK Biopharmaceuticals teams up with Interon Labs to develop neuroimmune therapies for autism spectrum disorder (ASD).

Key Point: The collaboration will focus on IL-17 modulation, a novel approach for ASD treatment.

Implication: Potential breakthrough in ASD treatment, expanding SK Biopharm’s CNS portfolio beyond epilepsy.

🦽 Wandercraft’s Atalante X receives second FDA indication extension [7] [US • 3 Nov 2025]

https://www.globenewswire.com/news-release/2025/11/03/3179388/0/en/Wandercraft-Gains-Second-FDA-Indication-Extension-for-Atalante-X-in-Less-Than-Two-Years-Extending-Advanced-Robotic-Rehabilitation-for-More-Patients-with-Severe-Mobility-Loss.html

Context: Atalante X exoskeleton now FDA-approved for patients with spinal cord injury (SCI) from C4 to L5 and multiple sclerosis (MS).

Key Point: The extension expands the device’s use to more patients with severe mobility loss.

Implication: Significant step forward in advanced robotic rehabilitation, enhancing patient mobility and quality of life.

Why it Matters

FcRn blocker competition [1]: The EPIC study may solidify IMAAVY™ as a key player in gMG treatment, potentially influencing treatment strategies and payer decisions.
Breakthrough in gMG treatment [2]: Gefurulimab’s positive trial results suggest a new convenient, self-administered treatment option for patients with AChR+ gMG.
NF1 treatment expansion [3]: Koselugo’s EU approval expands treatment options for adult NF1 patients, following its success in pediatric populations.
Increased TD awareness [4]: Teva’s campaign could lead to better diagnosis and treatment for TD, which remains underdiagnosed in many populations.
BBB drug delivery innovation [5]: Roche’s investment in Manifold Bio could lead to improved treatments for CNS disorders by enhancing the delivery of therapeutics across the blood-brain barrier.
New ASD therapy on the horizon [6]: SK Biopharm’s collaboration with Interon Labs may provide a novel treatment for autism, broadening their CNS portfolio.
Robotic rehabilitation advances [7]: Wandercraft’s FDA extension for Atalante X brings advanced mobility restoration to a broader patient population, improving functional outcomes for SCI and MS patients.

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FAQ

What did Johnson & Johnson report about IMAAVY™ in gMG?

Johnson & Johnson launched the EPIC Phase 3b study comparing IMAAVY™ with efgartigimod in gMG, with new positive pediatric data from the Vibrance-MG study showing sustained disease control and IgG reductions [1].

What are the results of AstraZeneca’s gefurulimab trial?

Gefurulimab met its primary endpoint in the PREVAIL Phase III trial, showing a significant improvement in MG-ADL scores, with early effects observed as soon as week 1, offering a promising self-administered option for gMG patients [2].

What are the key points from Koselugo’s EU approval?

Koselugo was approved for treating adult patients with symptomatic, inoperable plexiform neurofibromas associated with neurofibromatosis type 1, based on positive KOMET Phase III trial results [3].

What is the purpose of Teva’s ‘The Other TD’ campaign?

Teva launched the campaign to raise awareness about tardive dyskinesia (TD), highlighting the need for better diagnosis and treatment, especially for underdiagnosed groups [4].

How does Roche’s investment in Manifold Bio impact CNS drug development?

Roche’s $55M investment in Manifold Bio aims to enhance drug delivery across the blood-brain barrier, potentially improving treatments for CNS disorders such as Alzheimer’s [5].

What is SK Biopharm’s new collaboration with Interon Labs?

SK Biopharm partnered with Interon Labs to develop a novel neuroimmune therapy for autism spectrum disorder, using IL-17 modulation to target the immune system’s role in ASD [6].

What is the significance of Wandercraft’s FDA approval for Atalante X?

Wandercraft’s second FDA indication extension for Atalante X allows more patients with high-level spinal cord injury and multiple sclerosis to benefit from hands-free, self-balancing exoskeleton rehabilitation [7].

Entities / Keywords

Johnson & Johnson; IMAAVY™; EPIC study; generalized myasthenia gravis
AstraZeneca; gefurulimab; PREVAIL trial; Myasthenia Gravis Activities of Daily Living
Alexion; Koselugo; neurofibromatosis type 1; plexiform neurofibromas
Teva Pharmaceuticals; tardive dyskinesia; Terrell Davis; awareness campaign
Roche; Manifold Bio; blood-brain barrier; CNS therapeutics
SK Biopharmaceuticals; Interon Labs; autism spectrum disorder; IL-17 modulation
Wandercraft; Atalante X; exoskeleton; spinal cord injury; multiple sclerosis