Neuroscience Video Recap—November 12, 2025

LucidQuest

6 days ago

This biweekly video recaps the latest breakthroughs in CNS therapeutics—from promising trials to cutting-edge technologies—spotlighting the trends shaping current research and clinical practice

🎯 Watch Our Video Summary Capturing Neuroscience News from the Last Two Weeks

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Week 28 October–4 November 2025
Week 4–11 November 2025

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Transcript

Welcome to the latest edition of Neuroscience Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

Johnson & Johnson has announced the first head-to-head study comparing IMAAVY™ (nipocalimab) with another FcRn blocker, efgartigimod, for the treatment of generalized myasthenia gravis (gMG). The EPIC study, which aims to compare the efficacy and safety of both treatments in adults with gMG, could help establish IMAAVY™ as the preferred FcRn blocker for gMG patients. If successful, this study could set a new standard for gMG treatment and guide clinical decisions in the real-world setting.

AstraZeneca has reported positive results from its Phase III PREVAIL trial of gefurulimab for gMG. Gefurulimab showed significant improvements in key measures such as Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores. These results position gefurulimab as a promising treatment option for AChR-Ab positive gMG patients, with the added benefit of being a self-administered treatment. The early and sustained benefits observed could make gefurulimab a game-changer for gMG patients.

AstraZeneca also announced that Koselugo (selumetinib) has been approved in the European Union for adults with symptomatic, inoperable plexiform neurofibromas in neurofibromatosis type 1 (NF1). This approval follows positive Phase III trial results, which showed a 20% objective response rate. With this new approval, adults with NF1 now have a treatment option for this rare and challenging condition, addressing an unmet need in this patient population.

Wandercraft has gained a second FDA indication extension for Atalante X, a self-balancing exoskeleton designed for individuals with severe mobility loss. The extension allows the device to be used in patients with high-level spinal cord injury and multiple sclerosis. This development could significantly impact rehabilitation, enabling patients with severe mobility impairments to regain upright motion, potentially transforming rehabilitation approaches for these patients.

Roche has reported positive Phase III results for fenebrutinib in the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The study showed significant efficacy in reducing relapses in RMS and slowing disability progression in PPMS. If approved, fenebrutinib could offer a high-efficacy oral treatment option for both RMS and PPMS patients, marking a major advancement in the MS treatment landscape.

In another major development, Johnson & Johnson’s CAPLYTA® (lumateperone) has received FDA approval as adjunctive therapy for major depressive disorder (MDD) in adults. CAPLYTA® demonstrated superior efficacy and a favorable safety profile in pivotal clinical trials. With this approval, CAPLYTA® offers a new treatment option for the two-thirds of MDD patients who continue to experience residual symptoms despite antidepressant therapy.

MMI has received FDA Investigational Device Exemption (IDE) approval for the first robotic microsurgical study aimed at treating Alzheimer’s disease. The study will focus on restoring lymphatic drainage in the brain using robotic precision. This innovative approach could redefine treatment pathways for neurodegenerative diseases, potentially providing new hope for patients with Alzheimer’s and similar conditions in the future.

Lastly, Neurocrine Biosciences has provided an update on its Phase 2 study of NBI-1070770 for major depressive disorder (MDD), reporting that the study failed to meet its primary endpoint. Despite this setback, the data will be further explored to determine the next steps. While this outcome is disappointing, the findings could offer valuable insights for the development of future MDD treatments.

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Why It Matters

IMAAVY™ in gMG: The head-to-head study could solidify IMAAVY™ as a leading treatment for generalized myasthenia gravis, especially with its potential to treat both AChR and MuSK antibody-positive patients [1].
Gefurulimab for gMG: Gefurulimab’s early and sustained efficacy in gMG could offer patients a more effective and convenient treatment option, especially for those with AChR antibodies [2].
Koselugo in NF1: The approval of Koselugo in the EU provides a much-needed treatment for adults with inoperable plexiform neurofibromas, a rare complication of neurofibromatosis type 1 [3].
Atalante X in rehabilitation: Wandercraft’s FDA approval for Atalante X extends its use to patients with severe mobility loss, offering new hope for spinal cord injury and multiple sclerosis patients [4].
Fenebrutinib for MS: Fenebrutinib’s results could offer a breakthrough in treating both relapsing and primary progressive MS with an oral medication [5].
CAPLYTA® in MDD: The approval of CAPLYTA® for major depressive disorder provides a new treatment avenue for patients who do not fully respond to traditional antidepressants [6].
MMI’s robotic microsurgery for Alzheimer’s: The IDE approval for a robotic microsurgical intervention study could revolutionize treatment approaches for Alzheimer’s and other neurodegenerative diseases [7].
NBI-1070770 in MDD: While the Phase 2 study did not meet its endpoint, further analysis could lead to valuable insights for developing future MDD therapies [8].

🗓️ Explore weekly details and sources

Week 28 October–4 November 2025
Week 4–11 November 2025

📚 View the full Neuroscience archive on our research hub page.

FAQ

What is Johnson & Johnson’s head-to-head study in gMG?

The EPIC study compares IMAAVY™ with efgartigimod in adults with generalized myasthenia gravis, aiming to confirm IMAAVY™ as the preferred FcRn blocker for gMG patients [1].

What did gefurulimab show in the PREVAIL trial?

Gefurulimab demonstrated early and sustained improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores, positioning it as a promising treatment option for gMG [2].

How does Koselugo help NF1 patients?

Koselugo has been approved for adults with inoperable plexiform neurofibromas in neurofibromatosis type 1, offering a much-needed treatment option for this rare condition [3].

What is the significance of Atalante X?

Atalante X’s FDA extension allows use in patients with high-level spinal cord injuries and multiple sclerosis, offering hands-free gait training and rehabilitation [4].

What did Roche’s fenebrutinib show in MS trials?

Fenebrutinib significantly reduced relapses in relapsing multiple sclerosis and slowed disability progression in primary progressive multiple sclerosis, offering a potential breakthrough in MS treatment [5].

What’s new with CAPLYTA® in MDD?

CAPLYTA® was FDA-approved as adjunctive therapy for major depressive disorder, providing a treatment option for patients with residual symptoms despite existing antidepressant therapy [6].

What is MMI’s Alzheimer’s study?

MMI received FDA approval for a robotic microsurgical study aimed at restoring lymphatic drainage in the brain, potentially offering new treatment options for Alzheimer’s [7].

What happened with Neurocrine’s NBI-1070770 in depression?

The Phase 2 study of NBI-1070770 in MDD did not meet its primary endpoint, but further analysis is expected to guide future treatment development [8].

Entities / Keywords

Johnson & Johnson; IMAAVY™; generalized myasthenia gravis
AstraZeneca; gefurulimab; myasthenia gravis
AstraZeneca; Koselugo; neurofibromatosis type 1
Wandercraft; Atalante X; robotic exoskeleton; rehabilitation
Roche; fenebrutinib; multiple sclerosis
Johnson & Johnson; CAPLYTA®; major depressive disorder
MMI; robotic microsurgery; Alzheimer’s
Neurocrine Biosciences; NBI-1070770; major depressive disorder