Monthly neurology bulletin — October 8, 2026

Period covered: September 8 to October 8, 2026. The month was dominated by the MDS Congress in Seoul (movement disorders), FDA regulatory actions in Parkinson disease, multiple sclerosis and epilepsy, and a Chinese neuroprotection trial in stroke published in JAMA. It was a light month for acute stroke and for ALS: we found nothing verifiable and substantive on ALS within the window. Thirteen verified items are included.

Cerebrovascular disease

1. Intravenous neuroprotectant loberamisal improves 90-day functional outcome (LAIS trial)

[Clinical trial] [China]
Randomized, double-blind, placebo-controlled trial at 32 Chinese hospitals: 998 adults with ischemic stroke (NIHSS 7–20; median 8) randomized within 48 hours (median onset-to-treatment about 25 hours) to loberamisal 40 mg IV daily for 10 days or placebo; 997 analyzed. Thrombectomy was excluded and only about 17% received thrombolysis. mRS 0–1 at 90 days was 69.7% vs 56.3% (RR 1.24; 95% CI 1.12–1.36; absolute difference 13.3 percentage points). Serious adverse events 8.6% vs 10.7%; mortality 1.2% vs 2.0%. Published in JAMA on September 10, 2026.
Why it matters: an unusually large signal for a neuroprotectant, but the trial was funded by the manufacturer (NeuroDawn), in a Chinese population with moderate stroke, without thrombectomy and with few severe patients; it needs replication outside China before it changes practice, and the drug is not available in the Dominican Republic.
https://jamanetwork.com/journals/jama/article-abstract/2854043
https://www.criticalcarereviews.com/neuro/lais-trial
(Additional source in Russian: https://www.vidal.ru/novosti/loberamizal-uluchshil-funktsionalnyj-ishod-posle-ishemicheskogo-insulta-13012)

Neurodegenerative disease and cognition

2. FDA approves tavapadon (Juvmo), a D1/D5 partial agonist, for Parkinson disease

[Regulatory FDA] [United States]
Approved on September 28, 2026 (AbbVie) as monotherapy in early disease and as adjunct to levodopa in patients with motor fluctuations, once daily. In TEMPO-1 (n = 529), combined MDS-UPDRS II+III improved by 9.7 and 10.2 points (5 and 15 mg) vs a 1.8-point worsening with placebo; in TEMPO-3 (n = 507), ON time without troublesome dyskinesia increased by 1.7 hours vs 0.6 hours with placebo (difference 1.1 hours).
Why it matters: a new mechanism (D1/D5 partial agonism), but no trial compared it with levodopa or D2/D3 agonists, and the long-term extension data are open-label and company-generated.
https://news.abbvie.com/2026-09-28-U-S-FDA-Approves-AbbVies-JUVMO-TM-tavapadon-for-Parkinsons-Disease
https://www.neurologylive.com/view/fda-approves-tavapadon-for-the-treatment-of-parkinson-disease

3. LRRK2 inhibitor BIIB122 fails to slow early Parkinson disease (LUMA trial)

[Congress] [International — presented in Seoul, Korea]
Phase 2b, randomized, double-blind, placebo-controlled: 648 patients with early Parkinson disease (Hoehn and Yahr I–II, diagnosed within the previous 2 years) randomized to BIIB122 225 mg daily or placebo for 48–144 weeks. Time to confirmed worsening (≥6 points on MDS-UPDRS II+III): HR 1.04 (95% CI 0.85–1.28; P = .45). Peripheral LRRK2 inhibition exceeded 90%, but in a CSF substudy (n = 86) pRab10 fell by at most about 30%; discontinuation for adverse events 11.2% vs 4.6%. Presented as a late-breaking abstract at the MDS 2026 Congress (Seoul, October 4–8); Biogen and Denali had already announced in May that they were stopping development in idiopathic Parkinson disease.
Why it matters: an important negative result for the LRRK2 pathway in idiopathic Parkinson disease; it leaves open whether brain penetration was sufficient or whether the target matters only in mutation carriers.
https://www.neurologylive.com/view/lrrk2-inhibitor-biib122-fails-slow-early-stage-parkinson-disease
https://clinicaltrials.gov/study/NCT05348785

4. Metabolic agent vutiglabridin improves motor scores in early Parkinson disease

[Congress] [South Korea]
Korean phase 2a (9 sites), double-blind: 99 patients with newly diagnosed Parkinson disease randomized to 400 mg, 800 mg or placebo for 24 weeks. In the per-protocol analysis (77 patients), MDS-UPDRS III improved by 2.83 points with 800 mg vs a 0.73-point worsening with placebo (difference 3.56; P = .03). Presented at MDS 2026 in Seoul; the drug was originally developed by Glaceum for obesity.
Why it matters: small signal, per-protocol analysis, a single country and a non-peer-reviewed abstract; hypothesis-generating, not practice-changing.
https://www.neurologylive.com/view/metabolic-agent-vutiglabridin-improves-motor-scores-early-stage-study-parkinson-disease

5. Plasma biomarkers reveal distinct biological responses to lecanemab

[Publication] [United States]
Single-center longitudinal cohort (Washington University in St. Louis) of 197 lecanemab-treated patients followed for nearly 2 years with a 130-analyte proteomic panel. Thirty-four proteins changed with the number of infusions: some normalized, some overshot, and others, such as neurofilament light, moved away from control levels; the latter were not associated with cognitive course, whereas certain other proteins were associated with greater cognitive stability. Published in The Lancet Neurology on September 24, 2026.
Why it matters: it opens the door to blood markers for deciding when to repeat PET or stop the antibody, but these are unvalidated candidates from a single center, without ARIA analysis.
https://www.neurologylive.com/view/new-study-reveals-plasma-biomarkers-highlight-distinct-biological-responses-lecanemab-alzheimer-disease

Epilepsy, headache and sleep

6. Xenon submits NDA for azetukalner in focal seizures

[Regulatory FDA] [United States / Canada]
Xenon announced on September 17, 2026 that it had submitted the application, based on X-TOLE2 (phase 3, randomized, double-blind, 380 patients enrolled and 374 analyzed, drug-resistant focal seizures, 12 weeks): median seizure reduction of 53.2% with 25 mg and 34.5% with 15 mg vs 10.4% with placebo; ≥50% responders 54.8%, 37.6% and 20.8%. Dizziness in 20.5% with azetukalner vs 3.2% with placebo, and discontinuation for adverse events of 14.5% with 25 mg, 4.8% with 15 mg and 3.2% with placebo.
Why it matters: a Kv7 channel opener with one of the largest effect sizes in refractory focal epilepsy, but tolerability at 25 mg is a concern and head-to-head data against modern antiseizure medications are lacking.
https://investor.xenon-pharma.com/news-releases/news-release-details/xenon-announces-azetukalner-nda-submission-fda-focal-seizures
https://www.neurologylive.com/view/xenon-submits-new-drug-application-azetukalner-treatment-focal-seizures

7. Atogepant reduces menstrual migraine days (LUNA trial)

[Industry] [International]
AbbVie reported on September 10, 2026 that the phase 3 LUNA trial (NCT06806293; 468 women with menstrual migraine, sites in Europe and Asia) met its primary endpoint: perimenstrual migraine days fell by 1.20 with atogepant vs 0.40 with placebo (difference 0.80 days; P < .0001), and all 8 ranked secondary endpoints were met.
Why it matters: phase 3 data specific to menstrual migraine with a gepant, but the absolute difference is less than one day per cycle and so far there is only a company press release, without full publication.
https://www.neurologylive.com/view/aan-ahs-issue-updated-guideline-migraine-prevention-atogepant-meets-end-points-phase-3-trial-trientine-enters-phase-3-trial

8. ANVISA approves atogepant (Aquipta) for migraine prevention in Brazil

[Regulatory ANVISA] [Brazil]
The Brazilian agency announced on September 8, 2026 the approval of the oral gepant atogepant (AbbVie) for prevention of episodic and chronic migraine in adults with at least four migraine episodes per month. According to the Brazilian press, no pharmacy launch date has been set.
Why it matters: it expands access to oral anti-CGRP prevention in Latin America; price and public coverage will determine its real impact, and it is a useful precedent for access discussions in the Dominican Republic.
https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-aprova-medicamento-para-prevencao-de-enxaqueca
https://www.jornaldocomercio.com/geral/2026/09/1262610-anvisa-aprova-novo-medicamento-para-prevencao-da-enxaqueca.html
(sources in Portuguese)

Neuroimmunology and neuromuscular disease

9. FDA accepts fenebrutinib under priority review for relapsing and primary progressive MS

[Regulatory FDA] [International]
Genentech announced acceptance of the filing on September 29, 2026 (Roche on September 30). In FENhance 1 and 2 (relapsing MS, vs teriflunomide, 96 weeks), the annualized relapse rate fell by 51.1% and 58.5%. In FENtrepid (primary progressive MS, vs IV ocrelizumab), noninferiority was shown for confirmed disability progression (HR 0.88; 95% CI 0.75–1.03), without superiority.
Why it matters: it is the first BTK inhibitor to have an FDA filing accepted for both relapsing and primary progressive MS, and it would be the first oral drug for primary progressive disease, but liver enzyme elevations were more frequent than with ocrelizumab and an unspecified imbalance in deaths needs clarification.
https://www.roche.com/media/releases/med-cor-2026-09-30
https://www.neurologylive.com/view/fda-accepts-fenebrutinib-nda-under-priority-review-relapsing-primary-progressive-ms

10. Satralizumab on track to become the first approved drug for MOGAD

[Regulatory FDA] [International]
The FDA granted priority review, announced by Roche on September 10, 2026, with a decision expected by January 10, 2027. In the phase 3 METEOROID trial (relapsing MOGAD, age 12 and older), satralizumab reduced the risk of first relapse by 68% (P = .0025); 87% vs 67% were relapse-free at 48 weeks, and the annualized relapse rate fell by 66%.
Why it matters: MOGAD has no approved therapy and is currently managed by extrapolation; total enrollment and full data have not yet been published.
https://www.roche.com/media/releases/med-cor-2026-09-10
https://www.neurologylive.com/view/fda-priority-review-puts-satralizumab-track-first-mogad-drug

Cross-cutting

11. New AAN/AHS migraine prevention guideline

[Guideline] [United States] [Outside the period: August 31]
Published in Neurology on August 31, 2026 (included for its weight, although it falls outside the window). It recommends offering prevention to adults with at least 4 migraine or moderate-to-severe headache days per month or substantial disability; it names no preferred drug and asks clinicians to choose based on efficacy, tolerability, long-term safety, cost and preference; response should be assessed at 8–12 weeks (24 weeks for onabotulinumtoxinA), with sections on pregnancy, lactation, older adults and medication overuse.
Why it matters: it does not favor anti-CGRP therapies and gepants over classic preventives or vice versa, and it legitimizes choosing by cost, which is key in our setting.
https://www.aan.com/PressRoom/Home/PressRelease/5361

12. FDA clears MICSI-PET, AI software for automated neurological PET analysis

[Regulatory FDA / AI] [United States]
510(k) clearance (K261305, Microstructure Imaging) with an FDA decision date of September 11, 2026, reported on September 15: the software uses structural MRI to denoise and super-resolve PET images and automatically calculates Centiloid (amyloid), CenTauR (tau) and regional SUVr values with z-scores against controls.
Why it matters: automated PET quantification will be key in the anti-amyloid era, but no performance metrics or independent validation have been published.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261305
https://www.neurologylive.com/view/micsi-pet-cleared-by-fda-for-automated-neurological-pet-analysis

13. Latin American Epilepsy Congress abstracts published in Epilepsia for the first time

[Publication] [Latin America]
ILAE announced on September 29, 2026 a supplement of Epilepsia (vol. 67, S1) with more than 200 abstracts from the XIV Latin American Epilepsy Congress (Lima, May 16–18, 2026), in Spanish and English.
Why it matters: it gives indexed visibility to regional epilepsy research; a useful source of Latin American data, although these are abstracts without full peer review.
https://www.ilae.org/news-and-media/news-about-ilae/trabajos-libres-de-laec-2026-se-publican-por-primera-vez-en-epilepsia

No verifiable news this month on ALS, nor from Japan, India, Russia, the Middle East or Turkey, nor from the Dominican Society of Neurology and Neurosurgery.

Upcoming meetings and dates

• World Stroke Congress (WSC 2026): October 21–23, 2026, Seoul, Korea (COEX). https://www.world-stroke.org/news-and-blog/news/save-the-date-for-world-stroke-congress-2026/
• FDA decision on satralizumab in MOGAD: expected January 10, 2027 (beyond the 6-week window, worth keeping on the radar).

Monthly neurology bulletin — October 8, 2026

13 verified items from the past month, from JAMA, The Lancet Neurology, the MDS 2026 Congress (Seoul), and FDA and ANVISA decisions.

Three worth your time:
• Loberamisal (LAIS trial, JAMA): in 998 Chinese patients with ischemic stroke, 90-day mRS 0–1 was 69.7% vs 56.3% with placebo. Manufacturer-funded and without thrombectomy: it needs replication.
• LUMA: the LRRK2 inhibitor BIIB122 did not slow early Parkinson disease (648 patients; HR 1.04). A setback for the LRRK2 pathway in idiopathic disease.
• Fenebrutinib, under FDA priority review: relapses down 51% and 58% vs teriflunomide, and noninferior to ocrelizumab in primary progressive MS. Watch the liver signal.

Full bulletin, with a critical reading of each study and links to their sources:
https://boletinesmedicos.com/en/neurologia/2026-10-08.html

#Neurology #Stroke #Parkinsons #MultipleSclerosis #Migraine

Neurology, Oct 2026: loberamisal improves 90-day mRS 0–1 after stroke (69.7% vs 56.3%, JAMA); LRRK2 inhibitor BIIB122 fails in early Parkinson disease (HR 1.04). https://boletinesmedicos.com/en/neurologia/2026-10-08.html