This week’s Neuroscience update highlights regulatory progress, clinical data readouts, digital-health innovation, scientific advances, and evolving market-access developments across neurological disorders.

In Today’s Newsletter

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💉 Vyepti cleared in South Korea for migraine prevention [1] [South Korea • 26 May 2026]

https://news.cision.com/h–lundbeck-a-s/r/lundbeck-receives-marketing-authorization-for-vyepti—eptinezumab–in-south-korea-for-the-preventiv,c4352361
Context: Lundbeck’s Vyepti (eptinezumab) is an IV anti-CGRP monoclonal antibody for adult migraine prevention.
Key point: South Korea’s MFDS granted marketing authorization, supported by Phase 3 studies including SUNRISE in a predominantly Asian chronic-migraine population.
Implication: May influence prescriber choice and payer reviews pending full data.

📱 Theranica adds AI features and coverage for Nerivio [2] [US • 28 May 2026]

https://www.prnewswire.com/news-releases/theranica-advances-nerivio-as-a-transformative-therapy-for-personalized-migraine-care-302783660.html
Context: Nerivio is Theranica’s remote electrical neuromodulation wearable for acute and preventive migraine care.
Key point: Theranica announced AI-based “Your Day Ahead” features, real-world safety data, and US coverage reaching more than 150 million covered lives.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

🟣 Axsome backs migraine-awareness campaign [3] [US • 01 Jun 2026]

https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-partners-headache-alliance-highlight-impact
Context: Axsome Therapeutics is supporting Headache Alliance education during Migraine and Headache Awareness Month.
Key point: Activities include the first Headache in the City campaign in New York City and a purple lighting of One World Trade Center.
Implication: May expand screening, initiation, and follow-up at scale.

🧠 AHS sets 2026 headache-science agenda [4] [US • 27 May 2026]

https://www.businesswire.com/news/home/20260527631335/en/Groundbreaking-Headache-Medicine-Research-on-New-Frontiers-in-Treatment-Biomarkers-and-the-Gut-Brain-Axis-to-be-Presented-at-the-American-Headache-Society-68th-Annual-Scientific-Meeting
Context: The American Headache Society 68th Annual Scientific Meeting runs 04–07 Jun 2026 in Orlando, Florida.
Key point: The program includes more than 350 abstracts across treatment, biomarkers, gut-brain research, digital biomarkers, and personalized medicine.
Implication: May influence prescriber choice and payer reviews pending full data.

⚕️ Otsuka reports centanafadine ADHD post hoc analyses [5] [US • 29 May 2026]

https://www.otsuka.co.jp/en/company/newsreleases/2026/20260529_1.html
Context: Centanafadine is Otsuka’s investigational NDSRI under US FDA Priority Review for ADHD, with a PDUFA date of 24 Jul 2026.
Key point: Post hoc Phase 3 analyses in 744 adults associated centanafadine with improved executive function and emotional dysregulation at Week 6.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Praxis pauses POWER2 after vormatrigine miss [6] [US • 01 Jun 2026]

https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-provides-vormatrigine-program-update
Context: POWER1 is a Phase 2/3 study of vormatrigine in highly refractory focal-onset seizures.
Key point: Vormatrigine did not meet the primary success measure, though Praxis reported a met 50% response-rate measure and a stronger high-dose signal later in the study.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 NeuExcell presents NXL-004 glioma data at ASCO [7] [US • 31 May 2026]

https://www.manilatimes.net/2026/05/31/tmt-newswire/globenewswire/neuexcell-therapeutics-announces-encouraging-data-of-nxl-004-in-recurrent-malignant-glioma-at-2026-asco/2355169
Context: NXL-004 is NeuExcell’s first-in-class AAV6-NeuroD1 in vivo cell-conversion therapy for recurrent malignant glioma.
Key point: First-in-human data in 11 patients reported no drug-related serious adverse events and encouraging survival signals versus historical benchmarks.
Implication: May influence prescriber choice and payer reviews pending full data.

🧩 Ozanimod cognition analysis in relapsing MS [8] [US • 27 May 2026]

https://www.neurologylive.com/view/ozanimod-preserves-multiple-sclerosis-cognition-new-3-year-analysis
Context: ENLIGHTEN is an open-label Phase 3b study of ozanimod (Zeposia, BMS) in adults with relapsing MS.
Key point: An ad hoc analysis reported largely preserved SDMT-defined cognition over three years, with wide confidence intervals limiting interpretation.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🗣️ National MS Society releases patient-voice report [9] [US • 27 May 2026]

https://www.prnewswire.com/news-releases/national-ms-society-releases-voice-of-the-patient-report-capturing-the-lived-reality-of-multiple-sclerosis-302782506.html
Context: The Voice of the Patient report draws on nearly 3,000 survey responses and direct testimony from people affected by MS.
Key point: Respondents prioritized better treatments for fatigue, walking, spasticity, cognition, and bladder control, plus earlier diagnosis and progression control.
Implication: May expand screening, initiation, and follow-up at scale.

⚖️ Biogen faces Italian antitrust probe over MS test access [10] [Italy • 27 May 2026]

https://www.fiercepharma.com/marketing/biogen-investigated-italian-regulator-over-multiple-sclerosis-market-abuse-claims
Context: Italy’s AGCM is investigating Biogen and its Italian subsidiary over alleged conduct involving Stratify anti-JCV testing for natalizumab.
Key point: The regulator alleges Biogen may have limited access for patients using Sandoz’s Tyruko biosimilar; Biogen’s premises were inspected on 26 May 2026.
Implication: Introduces competition that may affect pricing and formulary access.

Why it Matters

  • Migraine care continues to broaden across biologics, neuromodulation, digital features, awareness, and scientific-meeting pipelines.
  • CNS regulation remains active, with South Korea authorizing Vyepti and the US FDA reviewing centanafadine.
  • Trial risk is visible in epilepsy, where Praxis paused POWER2 after POWER1 missed its primary measure.
  • MS stakeholders are pushing both evidence generation and access scrutiny, from patient-reported priorities to Italian antitrust claims.

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FAQ

What changed for Vyepti (eptinezumab) in South Korea?

Lundbeck said South Korea’s MFDS granted marketing authorization for Vyepti for adult migraine prevention, supported partly by SUNRISE data in a predominantly Asian chronic-migraine population. [1]

What is new with Theranica’s Nerivio?

Theranica announced AI-based app enhancements, including “Your Day Ahead,” plus real-world safety evidence and expanded US insurance coverage for Nerivio. [2]

What did Otsuka report for centanafadine in adult ADHD?

Otsuka presented exploratory post hoc analyses from two Phase 3 trials, reporting improvements in patient-reported executive function and emotional dysregulation at Week 6. [5]

Did Praxis’s vormatrigine POWER1 study succeed?

Praxis said POWER1 did not meet its primary success measure in focal-onset seizures, while a 50% response-rate measure was met and higher-dose signals were noted. [6]

What is the Biogen antitrust issue in Italy?

Italy’s AGCM is investigating whether Biogen used its Stratify anti-JCV test access to limit competition from Sandoz’s natalizumab biosimilar Tyruko. [10]

Entities / Keywords

Lundbeck, Vyepti, eptinezumab, anti-CGRP, MFDS, South Korea, SUNRISE, migraine prevention
Theranica, Nerivio, remote electrical neuromodulation, REN, Your Day Ahead, migraine, digital health
Axsome Therapeutics, Headache Alliance, Headache in the City, Migraine and Headache Awareness Month
American Headache Society, AHS 2026, biomarkers, gut-brain axis, GLP-1, personalized headache medicine
Otsuka, centanafadine, NDSRI, ADHD, executive function, emotional dysregulation, ASCP
Praxis Precision Medicines, vormatrigine, POWER1, POWER2, focal-onset seizures
NeuExcell Therapeutics, NXL-004, AAV6-NeuroD1, recurrent malignant glioma, ASCO 2026
BMS, ozanimod, Zeposia, ENLIGHTEN, relapsing MS, SDMT, cognition
National MS Society, Voice of the Patient, EL-PFDD, MS symptoms, disease progression
Biogen, Sandoz, Tysabri, Tyruko, natalizumab, Stratify, anti-JCV test, AGCM

References

  1. https://news.cision.com/h–lundbeck-a-s/r/lundbeck-receives-marketing-authorization-for-vyepti—eptinezumab–in-south-korea-for-the-preventiv,c4352361
  2. https://www.prnewswire.com/news-releases/theranica-advances-nerivio-as-a-transformative-therapy-for-personalized-migraine-care-302783660.html?tc=eml_cleartime
  3. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-partners-headache-alliance-highlight-impact
  4. https://www.businesswire.com/news/home/20260527631335/en/Groundbreaking-Headache-Medicine-Research-on-New-Frontiers-in-Treatment-Biomarkers-and-the-Gut-Brain-Axis-to-be-Presented-at-the-American-Headache-Society-68th-Annual-Scientific-Meeting
  5. https://www.otsuka.co.jp/en/company/newsreleases/2026/20260529_1.html
  6. https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-provides-vormatrigine-program-update
  7. https://www.manilatimes.net/2026/05/31/tmt-newswire/globenewswire/neuexcell-therapeutics-announces-encouraging-data-of-nxl-004-in-recurrent-malignant-glioma-at-2026-asco/2355169
  8. https://www.neurologylive.com/view/ozanimod-preserves-multiple-sclerosis-cognition-new-3-year-analysis
  9. https://www.prnewswire.com/news-releases/national-ms-society-releases-voice-of-the-patient-report-capturing-the-lived-reality-of-multiple-sclerosis-302782506.html
  10. https://www.fiercepharma.com/marketing/biogen-investigated-italian-regulator-over-multiple-sclerosis-market-abuse-claims

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