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Acumen Pharmaceuticals (ABOS) FDA Events

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FDA Events for Acumen Pharmaceuticals (ABOS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Acumen Pharmaceuticals (ABOS). Over the past two years, Acumen Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ACU193 and Sabirnetug. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Acumen Pharmaceuticals' Drugs in FDA Review

ACU193 - FDA Regulatory Timeline and Events

ACU193 is a drug developed by Acumen Pharmaceuticals for the following indication: For Early Alzheimer's Disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Sabirnetug - FDA Regulatory Timeline and Events

Sabirnetug is a drug developed by Acumen Pharmaceuticals for the following indication: for Early Alzheimer's Disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Acumen Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Acumen Pharmaceuticals (ABOS) has reported FDA regulatory activity for the following drugs: ACU193 and Sabirnetug.

The most recent FDA-related event for Acumen Pharmaceuticals occurred on July 10, 2025, involving Sabirnetug. The update was categorized as "Presentation," with the company reporting: "Acumen Pharmaceuticals, will present new findings at the upcoming Alzheimer's Association International Conference (AAIC®) 2025 in Toronto."

Current therapies from Acumen Pharmaceuticals in review with the FDA target conditions such as:

  • For Early Alzheimer's Disease - ACU193
  • for Early Alzheimer's Disease - Sabirnetug

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ABOS) was last updated on 7/11/2025 by MarketBeat.com Staff
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