Latest
Frontotemporal dementia therapy programs reach late-stage trials
Progranulin-replacement therapy in GRN-mutation FTD, ASO programs in C9orf72 FTD-ALS, and tau-targeted programs are emerging in a previously bare category.
Dementia with Lewy bodies care formalises around alpha-synuclein-aware management
Cholinesterase inhibitor optimisation, antipsychotic-avoidance protocols, RBD recognition pathways, and emerging alpha-synuclein-targeted programs are reshaping DLB care.
CIDP therapy reshapes around FcRn antagonist class entry
Efgartigimod CIDP indication, follow-on FcRn antagonist programs, and structured maintenance protocols are reshaping chronic inflammatory demyelinating polyneuropathy management.
Chronic neuropathic pain therapy reshapes around novel sodium channel mechanisms
Suzetrigine (Nav1.8 inhibitor) acute pain approval and follow-on Nav1.8 and Nav1.7 programs in chronic pain are reshaping non-opioid pain management.
By signal pillar
Clinical readouts
6The "clinically meaningful" debate around CDR-SB is not settling
The interpretive argument over whether a sub-half-point CDR-SB delta represents a clinically meaningful slowing of decline continues to shape regulatory, payer, and clinician views.
Donanemab introduces a finite-duration treatment model
Donanemab's protocol allows treatment cessation once amyloid plaque clearance is confirmed - a meaningfully different model from indefinite biologic dosing.
APOE4 genotype is reshaping eligibility, dosing, and disclosure
Anti-amyloid trial readouts and post-marketing surveillance both show APOE4 homozygotes face higher ARIA risk - pushing genotype testing into pre-treatment workflows.
GLP-1 receptor agonists enter Alzheimer's clinical trials
Phase 3 readouts on semaglutide in Alzheimer's are due, with mechanistic interest in metabolic, vascular, and inflammatory pathways.
Subcutaneous anti-amyloid formulations move toward filing
Subcutaneous lecanemab data has been submitted to regulators; subcutaneous donanemab is in late development. Both reframe the access question.
Tau-targeting programs advance behind the amyloid wave
Anti-tau immunotherapies and small molecules are progressing through mid-stage trials, with the field watching for the first credible clinical signal.
Regulatory
2NICE keeps the UK out of step with US and EU on anti-amyloid coverage
NICE's negative cost-effectiveness opinion on lecanemab and donanemab leaves the UK as a meaningful policy outlier, even after MHRA authorization.
FDA's accelerated approval pathway under continued post-Aduhelm scrutiny
Aducanumab's voluntary withdrawal in 2024 left lasting institutional caution about surrogate-endpoint approvals in neurodegeneration.
Market access & reimbursement
4NICE's rejection of lecanemab and donanemab is widening the transatlantic access gap
Final NICE guidance declined both anti-amyloid antibodies for routine NHS use on cost-effectiveness grounds. The same products are reimbursed in Germany and approved (with payer fragmentation) in the US. The bifurcation is hardening rather than resolving.
Donanemab's limited-duration treatment paradigm is reshaping the lifetime cost calculation against lecanemab
Donanemab's protocol stops dosing once amyloid clearance is achieved, typically 12-18 months. Lecanemab is continuous indefinitely. Over a 10-year treatment horizon, the implied lifetime cost difference is substantial.
Tau PET reimbursement is the next diagnostic access question
Amyloid PET has settled into routine coverage and availability. Tau PET - which will be the confirmatory pathway for tau-directed therapies - is sited at meaningfully fewer centers and reimbursed unevenly. The access conversation that defined anti-amyloid rollout is about to repeat, one mechanism later.
Commercial payer coverage of anti-amyloid therapy is diverging from Medicare
Commercial payers are setting prior authorization and step-therapy criteria that meaningfully diverge from Medicare's coverage-with-evidence-development frame.
Policy & system
2Caregiver support is becoming part of the Alzheimer's policy frame
CMS's GUIDE Model and adjacent caregiver-support policy are reshaping how dementia care is paid for outside the medication and diagnostic frame.
Medicare's coverage-with-evidence-development decision still shapes the rollout
The CMS coverage framework requiring registry participation has had measurable effects on which sites prescribe and where patients get treated.
Scientific
22Frontotemporal dementia therapy programs reach late-stage trials
Progranulin-replacement therapy in GRN-mutation FTD, ASO programs in C9orf72 FTD-ALS, and tau-targeted programs are emerging in a previously bare category.
Dementia with Lewy bodies care formalises around alpha-synuclein-aware management
Cholinesterase inhibitor optimisation, antipsychotic-avoidance protocols, RBD recognition pathways, and emerging alpha-synuclein-targeted programs are reshaping DLB care.
CIDP therapy reshapes around FcRn antagonist class entry
Efgartigimod CIDP indication, follow-on FcRn antagonist programs, and structured maintenance protocols are reshaping chronic inflammatory demyelinating polyneuropathy management.
Chronic neuropathic pain therapy reshapes around novel sodium channel mechanisms
Suzetrigine (Nav1.8 inhibitor) acute pain approval and follow-on Nav1.8 and Nav1.7 programs in chronic pain are reshaping non-opioid pain management.
Restless legs syndrome therapy reshapes around augmentation avoidance
Alpha-2-delta ligand first-line preference, low-dose opioid use, and novel mechanism programs are restructuring restless legs syndrome management.
Post-stroke spasticity therapy options widen past oral baclofen
Botulinum toxin maturity, intrathecal baclofen pump access, and emerging novel mechanism programs are reshaping post-stroke spasticity management.
Stroke prevention restructures across atrial fibrillation, lipids, and acute window
Factor XIa inhibitors entering late-stage trials, expanded thrombectomy windows, and tenecteplase displacement of alteplase are restructuring stroke prevention and acute care.
Diabetic peripheral neuropathy therapy advances after a long quiet period
Capsaicin patch maturity, novel sodium channel modulators, and emerging disease-modifying programs are reshaping diabetic peripheral neuropathy management.
Genetically-targeted Parkinson's programs reach pivotal data
LRRK2 inhibitors and GBA-targeted programs in Parkinson's disease are reading out as the first genetically-defined Parkinson's therapy options.
Tardive dyskinesia therapy access patterns
Approved VMAT2 inhibitor therapy for tardive dyskinesia continues to expand but underdiagnosis remains the primary gap.
Concussion and TBI biomarker tools mature
Plasma GFAP and UCH-L1 assays for concussion and traumatic brain injury are establishing routine emergency-department use.
Progressive MS as the open question
Therapy for relapsing MS is mature; primary and secondary progressive disease remains the unsolved problem.
Plasma biomarker testing is displacing amyloid PET as the screening modality for anti-amyloid eligibility
Three FDA-cleared blood tests for amyloid pathology are now in routine use at major Alzheimer's centres, materially reducing the amyloid-PET demand that constrained early lecanemab uptake.
Advanced delivery options in Parkinson's
Subcutaneous levodopa, deep brain stimulation, and continuous infusion are reshaping how advanced Parkinson's disease is managed.
CGRP therapy normalises in migraine care
CGRP-class agents have moved from specialty curiosity to routine migraine prevention and acute treatment.
Gantenerumab post-mortem: what the failure tells the field about Abeta-targeting
The gantenerumab phase 3 readout failure is a useful data point for understanding what differentiates the successful anti-amyloid antibody class from the unsuccessful programs. The implications for next-generation amyloid-targeting and adjacent neurodegeneration pipeline are material.
Parkinson's biomarker work is converging on the alpha-synuclein seed-amplification assay
The alpha-synuclein seed-amplification assay (alpha-syn-SAA) has emerged as the leading biomarker for Parkinson's disease and adjacent synucleinopathies. The assay's sensitivity, specificity, and the implications for both diagnosis and trial-enrolment are material.
Co-pathology recognition is reshaping how Alzheimer's diagnosis is being read
LATE, vascular contribution, and Lewy-body co-pathology are now routinely on the differential when a patient with cognitive symptoms tests amyloid-positive. The clinical question is increasingly "what mix" rather than "is it Alzheimer's."
Parkinson's disease-modifying programs in motion
Multiple late-stage programs are testing whether Parkinson's disease modification can be demonstrated.
Smouldering MS as the new frontier
Beyond relapses, smouldering disease is increasingly the lens through which MS therapy is judged.
Blood-based biomarkers move from research to clinical workflow
Plasma p-tau217 assays are being adopted as a triage step before PET or CSF confirmation in specialty memory clinics.
Alzheimer's: still watching the pipeline
Anti-amyloid therapy is now a routine option in selected patients; the next mechanism class is the open question.
Real-world evidence
4ARIA monitoring infrastructure is the rate-limit on anti-amyloid uptake
Centres prescribing lecanemab and donanemab consistently report that MRI surveillance capacity, not patient demand or insurance approval, is the bottleneck on how many patients they can treat in 2026.
Real-world ARIA rates from registries are landing close to trial estimates
Early registry data on lecanemab and donanemab in routine clinical use is producing ARIA incidence numbers that broadly track the pivotal trials, with APOE4 homozygotes consistently the highest-risk group.
Plasma-biomarker rollout is concentrated at academic centers
Adoption of plasma p-tau217 testing remains concentrated at academic medical centers and large specialty practices, with community uptake meaningfully behind.
Lecanemab uptake constrained by infusion infrastructure, not demand
Real-world rollout of lecanemab is gated by infusion-chair capacity and MRI monitoring schedules - not by patient interest or prescriber willingness.