Neurology Regulatory Calendar

NeuroMarket Pulse — Reference

🧠 Neurology Regulatory Calendar

Updated March 5, 2026 • Covers Q1 2026 – Q1 2027

Neurodegeneration

Migraine

MS

Neuromuscular

Platform

Q1 2026 — Active Now

Timing	Asset	Company	Vertical	Event / Catalyst	Impact
Mar 2026	Tolebrutinib	Sanofi	MS	FDA resolution path / advisory committee decision expected CRL received Dec 2025 for nrSPMS. Expanded access protocol submitted. EU review ongoing.
Mar 2026	BIIB122 LRRK2 inhibitor	Biogen / Denali	Neurodegeneration	Phase 2b LUMA trial expected completion 650 patients, LRRK2-targeted disease modification in early PD. MDS-UPDRS Parts II+III primary endpoint.
Q1 2026	Cemdisiran C5 siRNA	Regeneron	Neuromuscular	US regulatory submission planned (gMG) Quarterly SC dosing. NIMBLE Phase 3 positive: 2.3-pt placebo-adjusted MG-ADL improvement.
Q1 2026	Remternetug anti-pyroGlu Aβ	Eli Lilly	Neurodegeneration	TRAILRUNNER-ALZ 1 Phase 3 topline readout expected 1,600+ early symptomatic AD patients. SC + IV formulations. Amyloid plaque clearance primary endpoint.

Q2 2026 — April–June

Timing	Asset	Company	Vertical	Event / Catalyst	Impact
Q2 2026	AMT-130 HTT gene therapy	UniQure	Neurodegeneration	Type B meeting with FDA on Phase 3 design FDA requires sham-controlled RCT. 75% disease progression reduction in high-dose Ph1/2. Study design critical for timeline.
H1 2026	Tavapadon D1/D5 partial agonist	AbbVie	Neurodegeneration	PDUFA decision expected (Parkinson's disease) NDA filed Sep 2025. TEMPO 1-3 all positive. First-in-class D1/D5 mechanism. Once-daily oral.
H1 2026	Leqembi SC Weekly lecanemab sBLA	Eisai / Biogen	Neurodegeneration	FDA decision on once-weekly SC autoinjector dosing 500mg SC regimen (2×250mg). Home administration. Expands treatment flexibility vs biweekly IV.
H1 2026	Fenebrutinib BTK inhibitor	Roche	MS	FENhance RMS Phase 3 readout + regulatory filing expected FENhance 2 positive (ARR vs teriflunomide). FENtrepid positive in PPMS (vs Ocrevus). First BTK filing in both RMS + PPMS.
H1 2026	GTx-104 IV nimodipine	Grace Therapeutics	Platform	FDA decision for aneurysmal subarachnoid hemorrhage STRIVE-ON Phase 3: 19% reduction in clinically significant hypotension vs oral nimodipine.
H1 2026	Bocunebart anti-PACAP mAb	Lundbeck	Migraine	Phase 2b IV formulation completion expected Pivoted from SC to IV after interim analysis. Targets CGRP non-responders. Phase 3 decision follows.
H1 2026	P2B001 pramipexole + rasagiline	Pharma Two B	Neurodegeneration	NDA submission to FDA planned (Parkinson's disease) Phase 3 positive (Movement Disorders, Nov 2023). Once-daily low-dose combination. Fewer sleep/dopaminergic AEs.

H2 2026 — July–December

Timing	Asset	Company	Vertical	Event / Catalyst	Impact
H2 2026	Buntanetap APP inhibitor	Annovis Bio	Neurodegeneration	Phase 3 six-month symptomatic analysis readout (Alzheimer's) 84 active sites. Biomarker-confirmed amyloid. FDA agreed to study design supporting dual NDA (symptomatic + DMT).
H2 2026	Claseprubart C1s complement inhibitor	Dianthus	Neuromuscular	Phase 3 CAPTIVATE interim data (CIDP) + Phase 2 MoMeNtum topline (MMN) CAPTIVATE: ~480 CIDP patients. MoMeNtum: 36 MMN patients. Phase 3 gMG trial also initiating.
H2 2026	Bocunebart anti-PACAP mAb	Lundbeck	Migraine	Phase 3 initiation decision (migraine prevention) Contingent on H1 Phase 2b IV data. If positive, first PACAP program to enter pivotal trials.
Mid-2026	SLTE-1009 anti-PACAP mAb	Slate Medicines	Migraine	Phase 1 initiation $130M Series A (Feb 2026). Licensed from DartsBio. Second PACAP entrant targeting CGRP non-responders.
H2 2026	Cobenfy xanomeline/trospium	BMS	Neurodegeneration	ADEPT-2 Phase 3 ongoing (AD psychosis) Clinician-rated psychosis scale primary endpoint. Already approved for schizophrenia. AD-P indication would expand TAM significantly.
2026	Takeda/AC Immune anti-Aβ vaccine	Takeda	Platform	Phase 2 anti-amyloid vaccine readout expected Active immunization approach. Could complement passive antibody therapies. Lower cost-of-goods potential.
2026	VO659 ASO (Huntington's)	Vico Therapeutics	Neurodegeneration	FDA clears US trial initiation; twice-yearly dosing Antisense approach to huntingtin lowering. Less invasive than gene therapy (intrathecal vs brain surgery).

2027 Horizon — Longer-Term Catalysts

Timing	Asset	Company	Vertical	Event / Catalyst	Impact
2027+	Trontinemab brain shuttle anti-Aβ	Roche	Neurodegeneration	Phase 2/3 data expected (Alzheimer's disease) Transferrin receptor–mediated BBB crossing. Lower dose, potentially less ARIA. Could redefine AD antibody class.
2027+	Etalanetug anti-MTBR tau	BMS	Platform	Tau NexGen Phase 2/3 + Study 202 Phase 2 in sporadic AD FDA Fast Track. Tested alongside Leqembi (anti-amyloid + anti-tau combo). DIAN-TU dominantly inherited AD cohort.
2028	Buntanetap	Annovis Bio	Neurodegeneration	Phase 3 eighteen-month DMT readout (Alzheimer's) Disease-modification endpoint following H2 2026 symptomatic read. Could support dual-indication NDA.
2029	Remternetug	Eli Lilly	Neurodegeneration	TRAILRUNNER-ALZ 1 full trial completion Full 18-month efficacy + safety dataset. NDA filing could follow if interim amyloid clearance supports accelerated pathway.

Key Conferences 2026

Date	Conference		Verticals	Watch For	Impact
Feb 2026	ACTRIMS Forum		MS	BTK inhibitor data updates, CIDP grip strength analyses, PRL biomarker validation
Apr 2026	AAN Annual Meeting		ND MS MIG	Cross-vertical abstracts: tavapadon long-term, fenebrutinib updates, CGRP real-world data, tau combination results
Jun 2026	AHS Annual Meeting		Migraine	PACAP pipeline updates, CGRP CV safety follow-up, pediatric migraine data, gepant real-world evidence
Jul 2026	AAIC 2026		ND PLAT	Remternetug data, blood biomarker validation, anti-tau combo data, AI diagnostic platforms
Sep 2026	ECTRIMS 2026		MS	Fenebrutinib filing update, tolebrutinib path forward, PRL-guided treatment selection, remibrutinib Phase 3 enrollment
Oct 2026	CTAD 2026		ND	Buntanetap Phase 3 symptomatic readout, Leqembi real-world adoption data, next-gen amyloid pipeline