Neuroscience Today — November 19, 2025

This week’s neuroscience news brings you the most important developments, regulatory updates, and industry breakthroughs across biopharma.

In Today’s Newsletter

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🧠 Lundbeck files Asian NDAs for Vyepti (eptinezumab) [1] [14 Nov 2025]

https://www.prnewswire.com/news-releases/lundbeck-files-for-marketing-authorization-across-key-asian-markets-for-vyepti-eptinezumab-for-the-preventive-treatment-of-migraine-302615423.html
Context: NDA acceptance in Japan, with similar applications accepted in China and South Korea, supported by SUNRISE Phase 3 in Asian patients.
Key point: First potential Lundbeck marketing authorization in Japan, and first biologic launch by Lundbeck in China and South Korea if approved.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.

💊 Pfizer launches rimegepant ODT in India for acute migraine [2] [IN • 17 Nov 2025]

https://www.biospectrumindia.com/news/16/26934/pfizer-launches-new-rimegepant-oral-medication-in-india-for-rapid-migraine-relief-.html
Context: 75 mg orally disintegrating tablet for adults with prior insufficient response to triptan.
Key point: Positions CGRP receptor antagonist for rapid, sustained relief up to 48 hours, with convenient water-free administration.
Implication: Access programs: May expand screening, initiation, and follow-up at scale.

🧬 TYRUKO (natalizumab-sztn) US launch, first MS biosimilar [3] [US • 17 Nov 2025]

https://www.sandoz.com/sandoz-launches-tyrukor-natalizumab-sztn-us-first-and-only-multiple-sclerosis-biosimilar/
Context: FDA-approved for all Tysabri indications; distributed via REMS addressing PML risk; Labcorp JCV testing offered at no cost to eligible patients.
Key point: First and only US MS biosimilar, expected growth driver, also available in 14 European countries.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.

🧪 FPR1 mechanism in neurodegeneration, T0080 candidate unveiled [4] [CN • 14 Nov 2025]

https://www.yicaiglobal.com/news/chinese-scientists-make-breakthrough-in-treating-neurodegenerative-diseases
Context: Tianjin Medical University team publishes in Science, identifying FPR1 as driver of CNS inflammation and degeneration in models.
Key point: Small-molecule FPR1 antagonist T0080 shows preclinical efficacy and is preparing for clinical trials.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.

🔬 Aldeyra extends RASP platform to CNS; reproxalap inspections closed VAI [5] [13 Nov 2025]

https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-expansion-rasp-platform-include
Context: ADX-248 preclinical signals in Parkinson’s and ALS models, with functional and biomarker improvements; FDA facility inspections for reproxalap closed as VAI.
Key point: Company broadens target indications to neuroinflammatory CNS diseases; manufacturing status updated.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.

🧓 IGC Pharma wins US patent covering IGC-AD1 composition [6] [US • 13 Nov 2025]

https://finance.yahoo.com/news/uspto-grants-igc-pharma-patent-140000386.html
Context: USPTO grants patent on methods and composition for treating CNS disorders, including AD agitation and pathology.
Key point: Claims span Aβ, tau, mitochondrial function, and neuroinflammation mechanisms, aligned to Phase 2 CALMA program.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.

🧴 NeOnc’s intranasal NEO100 shows signals in recurrent IDH1-mutant astrocytoma [7] [12 Nov 2025]

https://www.manilatimes.net/2025/11/12/tmt-newswire/globenewswire/neonc-technologies-reports-updated-clinical-results/2222004
Context: Combined Phase 1/2a plus compassionate cohort, n=24, recurrent WHO Grade III/IV IDH1-mutant astrocytoma.
Key point: Reported radiographic responses and PFS-6 signal, with no significant toxicity; endpoints and comparators are source-described.
Implication: Observational/RWE: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧫 Regulatory momentum for organoid neurotoxicity NAMs [8] [17 Nov 2025]

https://www.fiercebiotech.com/sponsored/regulatory-momentum-builds-organoid-neurotoxicity-testing
Context: Sponsored analysis summarizing 2025 US policy steps toward NAMs and standardization efforts for CNS safety testing.
Key point: Highlights push for human-relevant, reproducible organoid models to detect seizurogenic and network-level risks earlier.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.

🧷 ABL Bio inks GSK and Lilly deals for BBB shuttle Grabody-B [9] [KR • 13 Nov 2025]

https://www.koreabiomed.com/news/articleView.html?idxno=29607
Context: Follows Sanofi license of ABL301; new platform deals span antibodies and nucleic acids, with disclosed upfronts.
Key point: Expands global network to deliver modalities across the BBB for neurodegenerative targets.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.

Why it Matters

MS care in the US gets its first biosimilar option, which may pressure Tysabri pricing and access [3].
Asia-focused migraine moves could broaden CGRP class availability and payer choices in Japan, China, and South Korea [1].
India adds an on-label CGRP ODT for acute migraine, improving convenience and potential adherence [2].
BBB delivery platforms and NAMs suggest a shift toward more brain-penetrant therapeutics and human-relevant safety data [8][9].
Early CNS oncology and neuroinflammation programs show directional promise but need controlled, larger studies [4][5][7].

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FAQ

What did Lundbeck file for in Asia, and what supports it?

Lundbeck filed Vyepti (eptinezumab) for preventive migraine, with NDA acceptance in Japan and applications accepted in China and South Korea, supported by SUNRISE Phase 3 in Asian patients [1].

Is TYRUKO interchangeable with Tysabri in the US?

The source states TYRUKO is FDA-approved for all Tysabri indications and is the first natalizumab biosimilar available in the US; interchangeability status is not specified in the source [3].

What exactly did Pfizer launch in India?

Pfizer launched rimegepant 75 mg orally disintegrating tablets for acute treatment of migraine in adults with prior insufficient response to triptan, emphasizing rapid and sustained relief and convenience [2].

What is ABL Bio’s Grabody-B, and who are the partners?

Grabody-B is a BBB shuttle targeting IGF1R to deliver CNS therapeutics. ABL Bio has platform deals with GSK and Lilly, and earlier licensed ABL301 to Sanofi [9].

What is NeOnc reporting in recurrent IDH1-mutant astrocytoma?

Updated results from Phase 1/2a and compassionate cases suggest radiographic responses and PFS-6 signal with intranasal NEO100, with reported tolerability; interpretation depends on study design [7].

What protection did IGC Pharma secure?

A US patent covering composition and methods for IGC-AD1 targeting AD agitation and disease mechanisms, aligned with its Phase 2 CALMA program [6].

Entities / Keywords

Vyepti, eptinezumab; rimegepant ODT; TYRUKO, natalizumab-sztn, Tysabri; FPR1, T0080; Aldeyra, ADX-248, reproxalap; IGC-AD1; NeOnc, NEO100, IDH1-mutant astrocytoma; NAMs, organoids, CNS safety; ABL Bio, Grabody-B, BBB shuttle; GSK, Lilly, Sanofi; CGRP; MS; migraine; ALS; Parkinson’s; Alzheimer’s.