Monthly neurology bulletin — September 28, 2026

Colleagues: this issue covers August 29 to September 28, 2026. It was a month driven by regulatory decisions (FDA, EMA, PMDA and ANVISA), with few new trials in acute stroke. We selected 13 verified items; five come from outside North America and Western Europe (Japan, China, Brazil and a Latin American network that includes the Dominican Republic).

Cerebrovascular disease

1. Stroke in young adults nearly doubled over 27 years

[Publication] [United States]
The Greater Cincinnati Northern Kentucky Stroke Study analyzed 2,076 first-ever strokes in people aged 20 to 54, published in Neurology on September 23. Incidence rose from 33.9 to 62.2 per 100,000 person-years between 1993-1994 and 2020, driven mainly by ischemic stroke (23.8 to 47.3); there was no comparable rise in intracerebral or subarachnoid hemorrhage. Documented substance use among cases rose from 4.6% to 40.2%, largely marijuana, and adjusted 30-day mortality fell from 11.7% to 9.4%.
Why it matters: this is single-region trend data without comparable data from people without stroke, so the rise cannot be attributed to any one factor; still, it supports screening young adults for hypertension, diabetes and substance use, a risk profile also common in Dominican practice.
https://www.uc.edu/news/articles/2026/09/more-young-adult-strokes-uc-study.html

2. China (NCN 2026): CABLE trial does not improve global cognition in small vessel disease

[Congress] [China]
At the 29th National Neurology Conference of the Chinese Medical Association (Xi'an, September 10-13), Wang Yilong's group (Beijing Tiantan Hospital) presented CABLE, a randomized, double-blind phase 2 trial of Yangxue Qingnao pills (5 g twice daily) versus placebo in 114 patients with cerebral small vessel disease and mild cognitive impairment. At 6 months there was no MoCA benefit; executive function improved (Stroop D difference −3.67; p=0.02) and fewer patients had moderate-to-severe basal ganglia enlarged perivascular spaces, with no change in white matter hyperintensities or total burden score. The same congress reviewed recombinant prourokinase data (PROST-2, n=1,552: symptomatic intracranial hemorrhage 0.3% vs 1.3% with alteplase).
Why it matters: CABLE is small, unpublished and negative on its primary endpoint; the executive-function signal is hypothesis-generating and needs the larger trial announced. Prourokinase is not available in our region. (source in Chinese)
https://news.qq.com/rain/a/20260915A0BI6700

Neurodegenerative disease and cognition

3. Ulefnersen meets primary endpoint in FUS-ALS (FUSION)

[Clinical trial] [United States / Japan]
Ionis and Otsuka announced on September 22 that FUSION (phase 1-3, randomized, double-blind) of the intrathecal antisense oligonucleotide ulefnersen met its primary endpoint versus placebo in 73 patients with FUS-ALS after 72 weeks. The endpoint was a joint-rank analysis of time to death or permanent ventilation, time to rescue, and change in ALSFRS-R at day 505 (p=0.0005); serum neurofilament light also improved.
Why it matters: this is a company release with no effect size or adverse-event rates; if confirmed, it would be the second genetically targeted ALS therapy after tofersen, but only for a very rare variant that requires genetic testing, which is scarce in the Caribbean.
https://ir.ionis.com/news-releases/news-release-details/ionis-announces-positive-topline-results-phase-3-fusion-study

4. Japan approves subcutaneous lecanemab pen

[Regulatory PMDA] [Japan]
On September 16, Japan approved the 250 mg subcutaneous lecanemab pen (Eisai) for early Alzheimer disease, allowing home dosing instead of biweekly intravenous infusions.
Why it matters: the subcutaneous route reduces infusion burden but not the need for MRI monitoring for ARIA; its arrival in Latin America will depend on registration, price and MRI capacity. (source in Japanese)
https://www.jmedj.co.jp/blogs/product/product_29261

5. Divergent biological responses to lecanemab in real-world care

[Publication] [United States]
A Washington University in St. Louis study in The Lancet Neurology measured 130 plasma proteins (NULISAseq CNS 120 panel) in 2,385 samples from 1,967 participants, 197 of whom were receiving lecanemab in clinical practice. Thirty-four proteins changed with the number of infusions, in different directions; proteins linked to amyloid clearance were largely different from those associated with later cognitive decline, and brain-derived tau forms discriminated better than peripheral forms.
Why it matters: this is an observational, exploratory study publicized by the assay maker; it suggests amyloid clearance is not the same as slowing neurodegeneration, but it cannot yet guide treatment selection.
https://www.globenewswire.com/news-release/2026/09/24/3368813/0/en/lancet-neurology-study-using-alamar-biosciences-technology-reveals-divergent-biological-responses-to-alzheimer-s-treatment.html

6. FDA approves zilganersen, first treatment for Alexander disease

[Regulatory FDA] [United States]
On September 3, the FDA approved zilganersen (Ionis), a quarterly intrathecal antisense oligonucleotide that lowers GFAP production, for pediatric and adult patients. In a randomized study of 49 patients versus no treatment, walking speed at 61 weeks was significantly better in patients aged 5 and older; the most common adverse events were vomiting, back pain, headache and post-lumbar puncture syndrome.
Why it matters: the control was no treatment rather than placebo, and effect sizes were not released; it matters as proof of concept in leukodystrophies, not as a general practice change.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-alexander-disease

Epilepsy, headache and sleep

7. Azetukalner filed with the FDA for focal seizures

[Regulatory FDA] [Canada]
Xenon Pharmaceuticals submitted an NDA on September 17 for azetukalner, a once-daily Kv7 channel opener, as adjunctive therapy for focal seizures in adults. In X-TOLE2 (n=380, median of 5 prior drugs, 12 weeks) median seizure reduction was −53.2% with 25 mg, −34.5% with 15 mg and −10.4% with placebo (p<0.001); ≥50% responders: 54.8%, 37.6% and 20.8%. Dizziness 20.5% vs 3.2%; discontinuation for adverse events 14.5% with 25 mg.
Why it matters: it would be the first Kv7 opener since ezogabine was withdrawn, with solid efficacy in drug-resistant epilepsy; tolerability and the lack of head-to-head data against cenobamate are the open questions.
https://investor.xenon-pharma.com/news-releases/news-release-details/xenon-announces-azetukalner-nda-submission-fda-focal-seizures

8. ANVISA approves atogepant for migraine prevention

[Regulatory ANVISA] [Brazil]
On September 8, ANVISA registered atogepant (AbbVie), an oral gepant, for adults with at least four migraine attacks per month. In ADVANCE (n=910) it reduced monthly migraine days by 4.1 versus 2.5 with placebo (≥50% response: 59% vs 29%); in PROGRESS (n=778, chronic migraine) by 6.9 versus 5.1 days.
Why it matters: it widens access to targeted oral prevention in the region, with a modest absolute benefit (1.6-1.8 days per month over placebo); the price, still pending, will decide real access. (source in Portuguese)
https://www.otempo.com.br/saude-e-bem-estar/2026/9/8/anvisa-aprova-novo-medicamento-para-tratamento-da-enxaqueca

9. Japan approves cenobamate, eptinezumab and pitolisant

[Regulatory PMDA] [Japan]
In the same September 16 package, Japan approved cenobamate for partial-onset seizures, intravenous eptinezumab for migraine prevention and pitolisant, the country's first H3 antagonist/inverse agonist; inebilizumab was also approved for generalized myasthenia gravis.
Why it matters: these are drugs already known in other markets, with no new data, but they confirm uptake in Asia. (source in Japanese)
https://www.jmedj.co.jp/blogs/product/product_29261

Neuroimmunology and neuromuscular disease

10. Priority review for satralizumab in MOGAD

[Regulatory FDA/EMA] [Switzerland / United States]
On September 10, the FDA granted priority review to satralizumab (Roche) for myelin oligodendrocyte glycoprotein antibody-associated disease, with a decision expected by January 10, 2027; the EMA also validated the application. In METEOROID (phase 3, double-blind, patients ≥12 years) relapse risk fell 68% versus placebo (p=0.0025), and at 48 weeks 87% versus 67% were relapse-free; annualized relapse rate −66%.
Why it matters: it would be the first approved drug for MOGAD; the trial stopped after only 28 adjudicated relapses, so precision is limited and full data are not yet published.
https://www.globenewswire.com/news-release/2026/09/10/3359176/0/en/u-s-fda-grants-priority-review-for-roche-s-enspryng-for-mogad-an-autoimmune-disease-with-no-approved-treatments.html

11. CHMP recommends ocrelizumab for relapsing MS from age 10

[Regulatory EMA] [Europe]
On September 18, the CHMP issued a positive opinion for intravenous ocrelizumab in patients aged 10 and older. In OPERETTA 2 (n=187, versus fingolimod) the annualized relapse rate was 48% lower (rate ratio 0.52; 95% CI 0.19-1.33, noninferiority met), with 48% fewer new or enlarging T2 lesions and 87% fewer gadolinium-enhancing lesions at 12 weeks.
Why it matters: the confidence interval on the clinical endpoint is wide; the firmest support is radiological. Useful for pediatric neurologists already using anti-CD20 therapy off label.
https://www.neurologylive.com/view/chmp-recommends-eu-approval-ocrelizumab-pediatric-relapsing-ms

12. FDA approves apitegromab for spinal muscular atrophy

[Regulatory FDA] [United States]
On September 11, the FDA approved apitegromab (Scholar Rock), an antibody that blocks myostatin activation, for patients aged 2 and older with SMA already on SMN2-targeted therapy. In SAPPHIRE (n=188 non-ambulatory, 52 weeks) the HFMSE difference was 2.2 points with 10 mg/kg (nominal p=0.0121), and 34.2% versus 13.5% improved by ≥3 points. The FDA warns of a higher fracture risk.
Why it matters: it is the first muscle-targeted SMA therapy, with a modest benefit and added cost on top of already expensive therapies; local applicability is limited while access to nusinersen or risdiplam remains restricted.
https://investors.scholarrock.com/news-releases/news-release-details/scholar-rock-announces-fda-approval-isembyldtm-apitegromab-mstn

Cross-cutting

13. LatAm-FINGERS: from evidence to implementation in Latin America

[Clinical trial] [Latin America, 11 countries including the Dominican Republic]
In Buenos Aires (September 16-17), the Alzheimer's Association and the World Dementia Council convened experts to discuss implementing LatAm-FINGERS, published in The Lancet on July 13. The trial randomized 1,065 adults aged 60 to 77 at risk of dementia to a structured multidomain program (physical activity, MIND diet, cognitive training, vascular risk control and socialization) or to health advice; the structured group improved global cognition about 55% more, with the largest effect on episodic memory.
Why it matters: the paper dates from July (outside the window) but is included for its regional weight and because the Dominican Republic was a trial site; the intervention is simple to replicate in primary care. (source in Spanish)
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)01278-X/abstract
https://www.infobae.com/salud/ciencia/2026/09/15/hasta-el-54-de-los-casos-de-demencia-se-podrian-prevenir-expertos-debaten-como-implementar-cinco-pilares-para-la-salud-cerebral-en-america-latina/

No verifiable news this month: new AAN, EAN, ESO, ILAE, IHS or MDS guidelines; artificial intelligence with new clinical data; Korea, India, Russia, the Middle East, Turkey, Australia and non-English-speaking Europe; COFEPRIS and DIGEMAPS.

Upcoming meetings and dates

• October 1-4: 34th International Congress of the Dominican Society of Neurology and Neurosurgery, Punta Cana Convention Center. https://diariosalud.do/34-congreso-internacional-neurologia-neurocirugia-2026
• October 21-23: 18th World Stroke Congress (WSC 2026), COEX, Seoul.
• December 27: FDA action date for relutrigine in SCN2A/SCN8A epileptic encephalopathies.
• January 10, 2027: FDA decision on satralizumab in MOGAD.

Curated by Aura Celeste Vascular · Medical Bulletins

Monthly neurology bulletin — September 28, 2026

13 verified items from Neurology, The Lancet, The Lancet Neurology and FDA, EMA, PMDA and ANVISA announcements.

Three worth your time:
• Stroke in young adults: incidence at ages 20-54 rose from 33.9 to 62.2 per 100,000/yr between 1993 and 2020 (Neurology). Single-region trend data; no causal inference.
• Azetukalner, the first Kv7 opener in years, is filed with the FDA: −53% focal seizures on 25 mg vs −10% on placebo (n=380). Dizziness in 1 in 5.
• Satralizumab in MOGAD: 68% lower relapse risk in METEOROID; FDA decision by January 10, 2027. Only 28 adjudicated relapses.

Full bulletin, with a critical read of each study and links to primary sources:
https://boletinesmedicos.com/en/neurologia/2026-09-28.html

#Neurology #Stroke #Epilepsy #MOGAD #ALS

Neurology, September: stroke at ages 20-54 nearly doubled (33.9→62.2 per 100,000), and azetukalner is filed with the FDA after cutting focal seizures 53% (vs 10% placebo). Full bulletin: https://boletinesmedicos.com/en/neurologia/2026-09-28.html