Neuroscience Weekly News - October 8th 2025

🧠 This Week in Neuroscience: China’s Nerivio Nod, Ocrevus in Pediatric MS, Octave’s Biomarkers, and More!

This week’s roundup highlights China’s approval of Theranica’s Nerivio, the first drug-free REN wearable for migraine, and Roche/Genentech’s OPERETTA 2 data showing Ocrevus rivaling Gilenya in pediatric MS. Octave Bioscience advances an AI-driven blood test for MS progression with Valhalla Foundation support, Dyne Therapeutics reports functional gains in DM1, C2N Diagnostics files for FDA review of its Alzheimer’s blood test, and Neurocrine posts long-term INGREZZA data in Huntington’s disease.

In Today’s Newsletter

✅ China clears REN wearable for migraine (Nerivio) [1] [China • 03 Oct 2025]

https://www.biospectrumasia.com/news/48/26698/china-approves-first-and-only-remote-electrical-neuromodulation-based-migraine-treatment.html
Context: Pier 88 Health (Greater China) and Theranica (Israel) announced NMPA approval.
Key point: First approval in China for a wearable using remote electrical neuromodulation for migraine, drug-free and smartphone controlled.
Implication: May expand screening, initiation, and follow-up at scale.

🧒 Ocrevus vs Gilenya in pediatric MS hits all goals [2] [EU • 02 Oct 2025]

https://multiplesclerosisnewstoday.com/ectrims/2025/10/02/ectrims-2025-ocrevus-equally-effective-gilenya-children-ms-trial-data/
Context: ECTRIMS presentation of Phase 3 OPERETTA 2 in pediatric-onset MS.
Key point: Noninferiority met vs Gilenya on relapse rate, with reported larger reductions in relapses and MRI activity with Ocrevus at interim.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Grant backs first MS progression blood test (Octave) [3] [US • 06 Oct 2025]

https://www.biospace.com/press-releases/octave-bioscience-awarded-valhalla-foundation-grant-to-accelerate-development-of-the-first-ms-disease-progression-test
Context: Octave to develop multi-protein biomarker models building on its MSDA test.
Key point: Valhalla Foundation funding supports an AI-enabled blood test aimed at tracking MS progression across RRMS, PPMS, SPMS.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧠 RNAi to the brain: Aerska launches with $21M seed [4] [01 Oct 2025]

https://firstwordpharma.com/story/6229151
Context: Dublin startup emerges from stealth to pair RNAi with brain-shuttle antibodies.
Key point: Platform targets BBB delivery for neuro diseases, initially genetic Alzheimer’s and Parkinson’s.
Implication: Signals pipeline investment and modality expansion.

🔬 Beyond BTK inhibitors in MS, remyelination in focus [5] [06 Oct 2025]

https://www.biospace.com/drug-development/beyond-btk-inhibitors-next-gen-ms-treatments-could-transcend-symptom-management
Context: Industry overview citing ECTRIMS updates and programs from Sanofi, Roche, Immunic, academics.
Key point: BTK inhibitors advance despite prior safety holds; parallel neuroprotective and remyelination strategies gain momentum.
Implication: Signals pipeline investment and modality expansion.

💪 Dyne’s DM1 candidate shows one-year functional gains [6] [06 Oct 2025]

https://www.manilatimes.net/2025/10/07/tmt-newswire/globenewswire/dyne-therapeutics-announces-additional-one-year-clinical-data-demonstrating-functional-improvement-from-phase-12-achieve-trial-of-zeleciment-basivarsen-dyne-101-for-myotonic-dystrophy-type-1-dm1/2195792
Context: Phase 1/2 ACHIEVE, n=6 at selected dose cohort; presented at WMS 2025.
Key point: Reported improvements across myotonia, functional tests, upper-lower limb strength, PROs; safety consistent with prior data (endpoint details as reported).
Implication: May influence prescriber choice and payer reviews pending full data.

💊 ANAVEX3-71 once-daily tablet meets PK/safety goal [7] [US • 02 Oct 2025]

https://www.manilatimes.net/2025/10/02/tmt-newswire/globenewswire/anavex-life-sciences-announces-successful-development-of-once-daily-oral-tablet-formulation-for-the-anavex3-71-program/2193833
Context: Phase 1b randomized comparison of immediate- vs modified-release in healthy adults.
Key point: Modified-release tablet showed PK supportive of once-daily dosing with safety consistent with prior studies.
Implication: Signals pipeline investment and modality expansion.

🧬 PrimeC lowers AD-linked microRNAs in Phase 2b samples [8] [US • 06 Oct 2025]

https://www.prnewswire.com/news-releases/neurosense-primec-produces-statistically-significant-reductions-in-alzheimers-disease-biomarkers-302575654.html
Context: Analysis of plasma from PARADIGM Phase 2b.
Key point: Reported significant reductions in AD-associated microRNAs tied to neuroinflammation and neurodegeneration.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧪 FDA filing for Alzheimer’s blood test using HRMS (C2N) [9] [US • 01 Oct 2025]

https://www.businesswire.com/news/home/20251001365748/en/C2N-Submits-U.S.-FDA-Regulatory-Filing-for-Its-Alzheimers-Disease-Blood-Test
Context: Submission for a multi-analyte algorithmic test quantifying plasma Aβ and p-tau isoforms.
Key point: Company positions it as a first of its kind; prior Breakthrough Device designation noted.
Implication: Introduces competition that may affect pricing and formulary access.

🧭 3-year INGREZZA data in Huntington’s chorea [10] [US • 06 Oct 2025]

https://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-new-three-year-data-demonstrating-sustained-clinical-benefits-and-established-safety-profile-of-ingrezza-valbenazine-capsules-for-huntingtons-disease-chorea-302575129.html
Context: Open-label KINECT-HD2, adults, once-daily dosing; MDS Congress.
Key point: Early and sustained TMC improvements through Week 156 and tolerability consistent with label, per analysis.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

Pediatric MS options remain limited; positive Ocrevus data could reshape treatment discussions. [2]
Objective MS progression tools are a gap; Octave’s approach, if validated, could aid earlier intervention. [3]
Non-pharmacologic migraine therapies broaden choice, especially where specialist access is constrained. [1]
BBB-shuttle and remyelination strategies diversify CNS pipelines beyond inflammation control. [4][5]
Practical diagnostics like C2N’s blood test may streamline AD workups in primary care. [9]

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FAQ

What exactly did OPERETTA 2 show for Ocrevus in pediatric MS?

Top-line ECTRIMS data indicate noninferiority vs Gilenya on relapses, with reported larger reductions in relapse risk and MRI activity at interim. Safety profiles appeared similar overall. Full endpoints are not yet published. [2]

How is Octave’s progression test different from MSDA?

MSDA tracks disease activity using multi-protein biomarkers. The new MSDP effort aims to measure progression, combining additional proteins with AI to generate longitudinal scores across MS phenotypes. Details will be peer-reviewed. [3]

What is unique about C2N’s FDA submission?

It is described as a first multi-analyte, HRMS-based blood test for AD pathology assessment, combining Aβ42/40 and p-tau217 ratios within a proprietary algorithm. C2N previously received Breakthrough Device designation. [9]

Did Dyne’s DM1 data include a large cohort?

The one-year analysis at the selected dose referenced n=6 within the randomized MAD portion, showing consistent functional and strength improvements, with safety consistent with earlier cohorts. [6]

Is PrimeC an AD drug now?

No approval claim. The new analysis shows reductions in AD-associated microRNAs from a Phase 2b study, suggesting modulation of disease-relevant pathways. Clinical efficacy in AD would need further trials. [8]

What is new for Huntington’s disease chorea with INGREZZA?

Open-label data suggest sustained chorea improvement and tolerability through three years, including early benefits. Concomitant antipsychotic use did not appear to blunt chorea improvements in the analysis. [10]

Entities / Keywords

Nerivio, remote electrical neuromodulation, NMPA; Ocrevus (ocrelizumab), Gilenya (fingolimod), pediatric-onset MS; Octave Bioscience, MS progression biomarkers; Aerska, RNAi, brain-shuttle antibodies, BBB; BTK inhibitors, tolebrutinib, fenebrutinib, remyelination; Dyne Therapeutics, z-basivarsen (DYNE-101), DM1; ANAVEX3-71, modified-release tablet; NeuroSense, PrimeC, microRNAs; C2N Diagnostics, HRMS Alzheimer’s blood test; Neurocrine, INGREZZA (valbenazine), KINECT-HD2.