Alzheimer's Disease2026-03-31

Alzheimer's Disease Drug Development Pipeline: March 31, 2026

Mar 16, 2026 – Mar 31, 2026

Seven events across seven companies defined the second half of March 2026, spanning all four event categories. Anavex withdrew its EU marketing authorization application for blarcamesine in early AD after the EMA CHMP indicated it could not issue a positive opinion. NeuroSense rescheduled its Health Canada pre-NDS meeting to May 2026 to strengthen the PrimeC regulatory package and signaled a near-term AD clinical readout. NKGen Biotech reported Phase 1 troculeucel data showing dose-responsive cognitive improvements in moderate AD at AD/PD 2026. Annovis Bio presented a Phase 3 enrollment update for buntanetap at AD/PD 2026 (760 participants, 83 US sites, dual 6- and 18-month readouts). ProMIS Neurosciences completed PRECISE-AD enrollment at 144 participants with DSMB clearance to the highest dose cohort and Q3 2026 blinded data expected. Acumen Pharmaceuticals closed a $35.75M RA Capital-led private placement to advance its TfR-targeting EBD program for AD. Lunai Bioworks acquired a prodrug BBB delivery platform from the Clemann Group for $20M in Series B Convertible Preferred.

Executive Summary

Period Highlights

Data Readout

  • Troculeucel (NKGen Biotech): NKGen reported combined Phase 1 data at AD/PD™ 2026 showing dose-responsive cognitive improvements in moderate AD, with 100% of patients stable or improved across all MCID thresholds and 50% improving from moderate to mild stage on CDR-SB at three months, supported by consistent plasma GFAP biomarker correlations. [3]

Trial Update

  • Buntanetap (Annovis Bio): Annovis Bio presented an AD/PD™ 2026 enrollment update for its Phase 3 buntanetap trial in early AD (NCT06709014), confirming the study is actively enrolling 760 participants across 83 US sites with dual efficacy readouts planned at 6 and 18 months. [4]
  • PMN310 (ProMIS Neurosciences): ProMIS reported full enrollment of 144 participants (exceeding the 128-patient target) in the PRECISE-AD Phase 1b trial, with the Data and Safety Monitoring Board having cleared advancement to the highest dose cohort and blinded six-month interim data expected in Q3 2026. [5]
  • PrimeC (NeuroSense Therapeutics): NeuroSense signaled a near-term readout of clinical and biomarker results from its Alzheimer's disease study expected in the coming weeks. [7]

Regulatory

  • Blarcamesine (Anavex): Anavex withdrew its EU marketing authorization application for blarcamesine in early Alzheimer's disease after the EMA's CHMP indicated it could not issue a positive opinion, marking the first major regulatory setback for the SIGMAR1 pathway in a late-stage context. [2]
  • PrimeC / Health Canada pre-NDS (NeuroSense Therapeutics — ALS program): NeuroSense rescheduled its Health Canada pre-NDS meeting to May 2026 to incorporate additional emerging clinical, biomarker, and survival data into the briefing package. This event relates to PrimeC's ALS program and is covered here because the same drug is in active Alzheimer's disease development. [7]

Funding / BD

  • EBD Program (Acumen Pharmaceuticals): Acumen closed a $35.75 million private placement led by RA Capital Management (existing investor, follow-on) with participation from ADAR1 Capital Management and Sands Capital, alongside NHP preclinical data demonstrating materially higher brain exposure for its transferrin-receptor-targeting EBD candidates versus native antibodies, with IND targeted for mid-2027. [1]
  • BBB Delivery Platform (Lunai Bioworks): Lunai executed a $20 million asset acquisition from the Clemann Group, issuing Series B Convertible Preferred at $1.50/share to obtain a prodrug-based BBB delivery platform and CNS Alzheimer's drug assets, an inorganic pipeline expansion, not a capital raise; there is no external investor to approach from this transaction. [6]

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