This weekly Neurology update covers key developments across clinical research, market access, and investor sentiment, including trial initiations, access expansions, and signals shaping future CNS innovation.
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🧪 Neurocrine starts Phase 2 for NBI-1065890 in tardive dyskinesia [1] [US • 26 Jan 2026]
https://www.prnewswire.com/news-releases/neurocrine-biosciences-initiates-phase-2-clinical-study-evaluating-nbi-1065890-in-adults-with-tardive-dyskinesia-302669338.html
Context: Randomized, double-blind, placebo-controlled, ~100 adults with TD; primary endpoint AIMS Items 1–7 change at Week 8.
Key point: NBI-1065890 is a selective VMAT2 inhibitor designed for potentially longer-acting TD options.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 BioNxt sublingual cladribine ODF boosts exposure in pigs ~40% vs tablet [2] [Canada • 21 Jan 2026]
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/bionxt-reports-final-preclinical-results-demonstrating-approximately-1129562
Context: Single-dose comparative study in adult miniature pigs; AUC 0–48 h measured with validated methods.
Key point: Sublingual ODF AUC 39.46 ng·h/mL vs 28.11 ng·h/mL for tablet, supporting progression to human PK.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧠 “Gold rush” in brain science, per JPM26 investor sentiment [3] [22 Jan 2026]
https://www.biospace.com/drug-development/the-new-gold-rush-in-brain-science
Context: VCs cite biomarkers, brain mapping, AI, and aging demographics; note 2025 CNS deal flow and select clinical failures.
Key point: Momentum spans neuro/CNS drugs and neurotech, including non-implantable stimulation and neuroAI.
Implication: Signals pipeline investment and modality expansion.
☢️ Plus Therapeutics sets 2026 REYOBIQ and CNSide milestones [4] [US • 22 Jan 2026]
https://www.manilatimes.net/2026/01/22/tmt-newswire/globenewswire/plus-therapeutics-provides-business-update-on-reyobiq-clinical-program-and-us-cnside-commercialization/2263510
Context: Company update includes financing extension and commercialization plans.
Key point: Targets ReSPECT-LM Phase 2 dose/interval data Q3 2026, ReSPECT-GBM Phase 2 completion and FDA EOP meeting with data Q4 2026, PBC Phase 1 start, manufacturing scale-up, and payer coverage goals.
Implication: Signals pipeline investment and modality expansion.
🧩 Re:Cognition Health offers Medicare-covered Leqembi/Kisunla at 4 US sites [5] [US • 22 Jan 2026]
https://www.prnewswire.com/news-releases/recognition-health-announces-medicare-coverage-for-fda-approved-early-stage-alzheimers-disease-treatments-at-its-four-us-clinics-302667061.html
Context: Clinics in Fairfax VA, Chicago IL, Houston TX, and Fort Worth TX; experience administering >11,500 ATT doses across US/UK.
Key point: Medicare coverage now available for eligible early-stage AD patients receiving lecanemab or donanemab at these centers.
Implication: May expand screening, initiation, and follow-up at scale.
Why it matters
- TD pipeline diversification could shape next-gen VMAT2 options in a mature class.
- Alternative cladribine delivery may address adherence and variability, pending human PK.
- Investor appetite in neuro/CNS and neurotech suggests sustained BD and capital flow.
- Radiotherapeutics and CSF diagnostics progress toward clearer clinical and commercial pathways.
- Medicare-enabled access may bring real-world uptake for disease-modifying AD therapies.
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FAQ
What is NBI-1065890 and how is it being tested?
A selective VMAT2 inhibitor from Neurocrine, now in a Phase 2, randomized, double-blind, placebo-controlled TD study (~100 adults) with AIMS change at Week 8 as the primary endpoint [1].
How much higher was cladribine exposure with BioNxt’s ODF vs tablet?
Approximately 40% higher in pigs, with AUC 0–48 h 39.46 ng·h/mL for ODF vs 28.11 ng·h/mL for tablet under study conditions; human PK is planned next [2].
What are Plus Therapeutics’ key 2026 targets for REYOBIQ and CNSide?
ReSPECT-LM Phase 2 dose/interval data in Q3 2026, ReSPECT-GBM Phase 2 completion with FDA end-of-phase meeting and data in Q4 2026, start ReSPECT-PBC Phase 1, manufacturing scale-up, and expanded payer coverage for CNSide [4].
Where can Medicare-covered Leqembi/Kisunla be accessed via Re:Cognition Health?
Clinics in Fairfax VA, Chicago IL, Houston TX, and Fort Worth TX now offer Medicare-covered treatment for eligible early-stage AD patients [5].
What is driving investor interest in neuro/CNS and neurotech in 2026?
Advances in biomarkers and brain mapping, aging demographics, and notable deal activity, alongside growth in non-implantable neurostimulation and neuroAI, despite recent clinical setbacks [3].
Entities / Keywords
Neurocrine Biosciences; NBI-1065890; VMAT2 inhibitor; tardive dyskinesia; AIMS.
BioNxt Solutions; cladribine; sublingual ODF; AUC; pharmacokinetics; Multiple Sclerosis.
BioSpace Insights; neurotech; neuromodulation; neuroAI; CNS M&A.
Plus Therapeutics; REYOBIQ; ReSPECT-LM; ReSPECT-GBM; ReSPECT-PBC; CNSide; radiopharmaceuticals; CSF diagnostics.
Re:Cognition Health; Leqembi (lecanemab); Kisunla (donanemab); Medicare coverage; early-stage Alzheimer’s disease.
References
- https://www.prnewswire.com/news-releases/neurocrine-biosciences-initiates-phase-2-clinical-study-evaluating-nbi-1065890-in-adults-with-tardive-dyskinesia-302669338.html
- https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/bionxt-reports-final-preclinical-results-demonstrating-approximately-1129562
- https://www.biospace.com/drug-development/the-new-gold-rush-in-brain-science
- https://www.manilatimes.net/2026/01/22/tmt-newswire/globenewswire/plus-therapeutics-provides-business-update-on-reyobiq-clinical-program-and-us-cnside-commercialization/2263510
- https://www.prnewswire.com/news-releases/recognition-health-announces-medicare-coverage-for-fda-approved-early-stage-alzheimers-disease-treatments-at-its-four-us-clinics-302667061.html
