Neuroscience Video Recap—November 26, 2025

This biweekly Neuroscience video recap covers regulatory decisions, regional launches, biosimilar entries, preclinical neuroscience findings, trial readouts, and pivotal-path planning—plus more.

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Week 12–18 November 2025
Week 19–25 November 2025

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Transcript

Welcome to the latest edition of Neuroscience Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

Lundbeck reports that new drug applications for eptinezumab were accepted in Japan, China, and South Korea, supported by the SUNRISE Phase 3 study in Asian patients. If approved, Vyepti could become Lundbeck’s first marketing authorization in Japan and its first biologic launches in China and South Korea, potentially shaping preventive migraine access and payer reviews.

Pfizer launched rimegepant orally disintegrating tablet, 75 mg, in India for acute migraine in adults with prior triptan insufficiency. The company cites rapid and sustained pain relief up to 48 hours, with ODT format improving usability, which may support remote prescribing and adherence.

Sandoz launched TYRUKO, natalizumab-sztn, in the United States as the first biosimilar to Tysabri, covering all reference product indications. A REMS is in place for progressive multifocal leukoencephalopathy risk with JCV testing. The biosimilar introduces competition that may influence pricing and formulary access for relapsing multiple sclerosis and adult Crohn’s disease.

A Tianjin Medical University team reported in Science that formyl peptide receptor 1, or FPR1, drives central nervous system inflammation, citing mouse models of multiple sclerosis. Their small-molecule antagonist T0080 reduced inflammation and slowed neurodegeneration in animals, and the team is preparing for clinical trials. Interpretation will depend on study design and control of confounders.

The FDA approved selumetinib, Koselugo, for symptomatic, inoperable neurofibromatosis type 1 plexiform neurofibromas in adults, based on the KOMET Phase 3, placebo controlled global study with objective response rate as the primary endpoint. Safety aligned with pediatric experience, and efficacy showed an ORR advantage versus placebo.

Novo Nordisk announced that two two year, randomized, double blind Phase 3 trials, evoke and evoke plus, in early symptomatic Alzheimer’s disease, totaling 3,808 participants, did not show superiority over placebo on the Clinical Dementia Rating Sum of Boxes. Biomarker changes did not translate to clinical benefit, and the extension studies were discontinued.

Plus Therapeutics completed an FDA Type B meeting on future clinical development plans for REYOBIQ in leptomeningeal metastases. The discussion addressed the design of a planned pivotal or registrational study, with protocol amendments expected and company guidance after meeting minutes in early 2026.

Contineum reported topline results from the randomized, double blind, placebo controlled Phase 2 VISTA proof of concept study of PIPE-307, an M1 antagonist, in relapsing remitting multiple sclerosis. The trial did not meet the primary outcome on low contrast letter acuity, nor secondary measures, while safety was acceptable. Full data are planned.

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Why It Matters

Asia-focused filings and an India launch highlight rapid CGRP pathway expansion and preventive options in underserved migraine markets [1][2].
First US MS biosimilar introduces meaningful competition in a high-cost biologic class with REMS-managed safety considerations [3].
Mixed neurology readouts, with an NF1 PN approval and AD Phase 3 negative, reinforce indication-specific development risk profiles [5][6].
China’s FPR1 program adds a novel neuro-immunology target with translational ambitions from strong preclinical signals [4].
LM program planning progresses while RRMS PoC disappointment underscores trial-design and endpoint challenges [7][8].

🗓️ Explore weekly details and sources

Week 12–18 November 2025
Week 19–25 November 2025

📚 View the full Neuroscience archive on our research hub page.

FAQ

What is Vyepti’s status in Asia?

NDAs for eptinezumab have been accepted in Japan, China, and South Korea, supported by the SUNRISE Phase 3 trial in Asian patients. Approvals would mark key firsts for Lundbeck in these markets [1].

What did Pfizer launch in India?

Rimegepant 75 mg orally disintegrating tablet for acute migraine, for adults with prior insufficient response to triptans. The company cites rapid, sustained relief and convenient ODT administration [2].

How is TYRUKO different from Tysabri?

TYRUKO is an FDA-approved biosimilar to Tysabri for all reference indications, launched in the US with a REMS for PML risk and JCV testing support via a Labcorp program [3].

What is the Chinese FPR1 breakthrough about?

A Science paper identifies FPR1 as a driver of CNS inflammation. The group’s antagonist T0080 reduced inflammation and neurodegeneration in animal models and is being prepared for clinical testing, per reports [4].

What changed for NF1 PN care in the US?

Selumetinib (Koselugo) gained FDA approval for adults with symptomatic, inoperable plexiform neurofibromas, supported by KOMET Phase 3 ORR results [5].

Did oral semaglutide work in early Alzheimer’s?

No. The evoke/evoke+ Phase 3 trials did not show benefit on CDR-SB versus placebo, despite biomarker improvements. Extensions will stop [6].

Entities / Keywords

Vyepti, eptinezumab; H. Lundbeck; SUNRISE.
Rimegepant ODT; Pfizer India; CGRP.
TYRUKO, natalizumab-sztn; Sandoz; Tysabri; REMS; PML; JCV.
FPR1; T0080; Tianjin Medical University; Science.
Koselugo, selumetinib; Alexion, AstraZeneca; NF1 PN; KOMET.
Semaglutide; Novo Nordisk; evoke, evoke+.
Reyobiq; Plus Therapeutics; leptomeningeal metastases.
PIPE-307; Contineum; RRMS; VISTA; LCLA.