Neuroscience Weekly News – October 1st 2025

LucidQuest

1 month ago

🧠 This Week in Neuroscience: Alzheimer’s EC Nod, Huntington’s Breakthrough, MS Durability, Parkinson’s NDA, & More

Stay current with pivotal neuroscience developments! This week’s roundup features the EC approval of Lilly’s Kisunla for early Alzheimer’s, pivotal Huntington’s data from uniQure, and durable MS outcomes with Novartis’ Kesimpta and TG’s BRIUMVI. AbbVie advances Parkinson’s with a tavapadon NDA, while China approves Theranica’s Nerivio migraine wearable.

In Today’s Newsletter

💬 Lundbeck teams with patient groups to “Raise the Bar” in migraine care [1] [US • 25 Sep 2025]

https://www.businesswire.com/news/home/20250923717592/en/Lundbeck-Collaborates-with-Migraine-Community-to-Raise-the-Bar-for-Migraine-Care
Context: RSurveys (AMF, AMD) show high disease impact and unmet preventive control among respondents.
Key point: New initiative with six advocacy orgs reframes migraine as progressive and promotes goal-focused, preventive care; launches a Patient Empowerment Guide.
Implication: May expand screening, initiation, and follow-up at scale.

🧠 Kesimpta switch data + 7-year OLE reinforced at ECTRIMS [2] [CH • 24 Sep 2025]

https://www.novartis.com/news/media-releases/new-novartis-data-further-support-benefits-kesimpta-relapsing-ms-following-switch-from-oral-disease-modifying-therapies
Context: Open-label designs; safety consistent with prior ofatumumab experience.
Key point: ARTIOS (Phase IIIb) showed low ARR and >90% NEDA-3 after switch from fingolimod/fumarates; ALITHIOS OLE showed >90% progression-free up to 7 years.
Implication: May influence prescriber choice and payer reviews pending full data.

🤖 AI-built real-world MS registry unveiled (Nira Medical/RMMSC) [3] [US • 24 Sep 2025]

https://www.prnewswire.com/news-releases/nira-medical-and-rocky-mountain-ms-clinic-to-present-first-of-its-kind-ai-powered-multiple-sclerosis-registry-at-ectrims-2025-302565902.html
Context: Poster at ECTRIMS; aims to speed RWE generation vs manual charting.
Key point: LLM (CHARM) abstracted 130k+ variables from unstructured EHRs for 4,241 MS patients; EDSS captured in >97% of visits.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧪 Kyverna KYV-101 CAR-T early MS signals (IITs) [4] [US • 24 Sep 2025]

https://www.globenewswire.com/news-release/2025/09/24/3155539/0/en/Kyverna-Therapeutics-Highlights-Potential-of-KYV-101-in-Multiple-Sclerosis-with-Data-from-Phase-1-Investigator-Initiated-Trials-to-be-Presented-at-ECTRIMS.html
Context: Small N; Stanford and UCSF presentations; bendamustine lymphodepletion used.
Key point: Phase 1 IITs in progressive MS show CNS penetration, B-cell reconstitution to naïve phenotype, stable/improved EDSS; no high-grade CRS/ICANS.
Implication: Signals pipeline investment and modality expansion.

🧴 BRIUMVI 6-year outcomes extend durability claims [5] [US • 24 Sep 2025]

https://www.globenewswire.com/news-release/2025/09/24/3155543/8790/en/New-Data-for-BRIUMVI-Demonstrate-89-9-of-Patients-with-Relapsing-Multiple-Sclerosis-Were-Free-from-Disability-Progression-After-6-Years-of-Continuous-BRIUMVI-Treatment.html
Context: ULTIMATE I/II OLE, ENHANCE dosing study, ENABLE observational data.
Key point: ~90% progression-free at 6 years; ARR as low as 0.012 in year 6; safety stable; real-world ENABLE shows low relapse rates.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 UnitedHealthcare covers CNSide® CSF assay nationally [6] [US • 25 Sep 2025]

https://www.globenewswire.com/fr/news-release/2025/09/25/3156177/0/en/plus-therapeutics-announces-national-coverage-agreement-with-unitedhealthcare-insurance-company-for-cnside-cerebrospinal-fluid-assay-for-metastatic-cns-cancer.html
Context: 11k+ tests since 2020; sensitivity 92%, specificity 95% cited from publications/FORESEE trial.
Key point: Plus Therapeutics’ CNSide test gains national agreement with UnitedHealthcare (effective 15 Sep); addresses leptomeningeal metastases monitoring.
Implication: May expand screening, initiation, and follow-up at scale.

🧬 FORE Bio plixorafenib passes interim in BRAF V600 CNS tumors [7] [US • 25 Sep 2025]

https://www.biospace.com/press-releases/fore-biotherapeutics-announces-positive-outcome-from-a-planned-interim-efficacy-analysis-for-the-forte-basket-study-evaluating-plixorafenib-as-a-monotherapy-for-recurrent-or-progressive-braf-v600-primary-cns-tumors
Context: Monotherapy “paradox breaker” BRAF inhibitor; ORR primary endpoint (n up to 50).
Key point: IDMC recommends continuing Phase 2 FORTE CNS basket after meeting protocol efficacy threshold; topline planned 2H26.
Implication: Signals pipeline investment and modality expansion.

🧷 EC authorizes Kisunla (donanemab) for early AD [8] [EU • 25 Sep 2025]

https://investor.lilly.com/news-releases/news-release-details/lillys-kisunla-donanemab-receives-marketing-authorization-0
Context: Based on TRAILBLAZER-ALZ 2/6; gradual titration lowered ARIA-E incidence vs earlier schedule.
Key point: EU nod for early symptomatic AD in amyloid-confirmed adults (ApoE4 non-carriers/heterozygotes); supports course completion once plaques minimal.
Implication: May influence prescriber choice and payer reviews pending full data.

🧠 uniQure AMT-130 pivotal Ph1/2 positive in Huntington’s [9] [24 Sep 2025]

https://www.uniqure.com/investors-media/press-releases
Context: 29 treated; external controls from Enroll-HD; BLA planned Q1 2026; safety manageable; CSF NfL below baseline.
Key point: High-dose AMT-130 met primary endpoint with 75% slowing on cUHDRS at 36 months vs propensity-matched control; TFC and other measures favored treatment.
Implication: May influence prescriber choice and payer reviews pending full data.

🇦🇺 TGA approves lecanemab (LEQEMBI) for mild AD [10] [AU • 24 Sep 2025]

https://www1.racgp.org.au/newsgp/clinical/new-era-for-alzheimer-s-treatment-lecanemab-gains
Context: Follows TGA approval of donanemab (May 2025); not a cure; monitoring required.
Key point: Reversal of prior rejection; indicated for mild cognitive impairment/mild dementia due to AD with amyloid confirmation; safety counseling emphasized.
Implication: May influence prescriber choice and payer reviews pending full data.

🧩 AbbVie files NDA for tavapadon in Parkinson’s [11] [US • 26 Sep 2025]

https://news.abbvie.com/2025-09-26-AbbVie-Submits-New-Drug-Application-to-U-S-FDA-for-Tavapadon-for-the-Treatment-of-Parkinsons-Disease
Context: D1/D5 partial agonist, once-daily; safety profile acceptable in Phase 3.
Key point: NDA supported by three positive Phase 3 TEMPO trials (early PD monotherapy and adjunct to levodopa); improved MDS-UPDRS and “on” time.
Implication: May influence prescriber choice and payer reviews pending full data.

🇨🇳 China NMPA approves Nerivio® REN migraine wearable [12] [CN • 29 Sep 2025]

https://www.prnewswire.com/news-releases/pier-88-health-and-theranica-announce-china-nmpa-approval-of-the-nerivio-ren-wearable-for-acute-treatment-of-migraine-302570133.html
Context: Registration certificate issued 11 Aug 2025; Pier 88 to integrate into digital ecosystem for adoption.
Key point: First REN-based device approved in China for acute migraine in adults; smartphone-controlled, drug-free therapy.
Implication: DTC/telehealth: Could streamline initiation and adherence via remote prescribing and logistics.

Why it matters

MS landscape: long-horizon anti-CD20 data and switch/OLE results may shift sequencing and earlier use [2][5].
Neuroimmunology: Early CAR-T and in vivo data point to B-cell “reset” concepts in MS and beyond [4].
Neurodegeneration: Dual approvals/authorizations (donanemab EU, lecanemab AU) intensify amyloid-targeting uptake and payer scrutiny [8][10].
Oncology diagnostics: National coverage for CSF tumor cell assay may standardize LM monitoring and treatment adjustments [6].
Digital/neuromod: China’s REN device approval expands non-pharmacologic migraine options at population scale [12].

📢 Stay Ahead in Neuroscience Research!

✅ Contact LucidQuest at info@lqventures.com for strategic guidance on neuroscience and breakthrough therapies

FAQ

What did Novartis show for Kesimpta in switchers?
ARTIOS suggested low ARR and >90% NEDA-3 after switching from fingolimod/fumarates; ALITHIOS OLE reported >90% progression-free up to seven years. Both were open-label; no new safety concerns reported [2].

How durable is BRIUMVI efficacy?
In ULTIMATE OLE, ~89.9% were progression-free after six years; ARR dropped to ~0.012 in year 6. Safety remained consistent; real-world data aligned with trials [5].

What is KYV-101’s status in MS?
Phase 1 IITs showed CNS penetration, B-cell reconstitution to naïve phenotype, and stable/improved EDSS with tolerable safety (no high-grade CRS/ICANS). Small cohorts; further study is needed [4].

What exactly did EU authorize for Kisunla?
Early symptomatic AD with confirmed amyloid in ApoE4 non-carriers/heterozygotes. Gradual titration reduced ARIA-E incidence in Phase 3b relative to earlier schedule [8].

How strong are uniQure’s Huntington’s data?
High-dose AMT-130 met the primary cUHDRS endpoint (75% slowing at 36 months vs external control) and a key TFC endpoint; safety manageable; BLA targeted for Q1 2026 [9].

What did AbbVie file for in Parkinson’s?
An NDA for tavapadon, a D1/D5 partial agonist. Across TEMPO trials, it improved MDS-UPDRS in early PD and increased “on” time as adjunct to levodopa; common AEs included nausea, headache, dizziness [11].

Entities / Keywords

Lundbeck; American Migraine Foundation; Association of Migraine Disorders; Novartis; Kesimpta (ofatumumab); Nira Medical; Century Health CHARM; Rocky Mountain MS Clinic; Kyverna Therapeutics; KYV-101 (CD19 CAR-T); TG Therapeutics; BRIUMVI (ublituximab-xiiy); Plus Therapeutics; CNSide® CSF assay; UnitedHealthcare; FORE Biotherapeutics; plixorafenib (BRAF “paradox breaker”); Eli Lilly; Kisunla (donanemab); uniQure; AMT-130 (Huntington’s); Eisai/Biogen; lecanemab (LEQEMBI); AbbVie; tavapadon (D1/D5); Theranica; Pier 88 Health; Nerivio (REN).