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Anavex Life Sciences (AVXL) FDA Events

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FDA Events for Anavex Life Sciences (AVXL)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Anavex Life Sciences (AVXL). Over the past two years, Anavex Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ANAVEX, ANAVEX®2-73, and ANAVEX®3-71. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Anavex Life Sciences' Drugs in FDA Review

ANAVEX 2-73 (blarcamesine) - FDA Regulatory Timeline and Events

ANAVEX 2-73 (blarcamesine) is a drug developed by Anavex Life Sciences for the following indication: 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.

ANAVEX®2-73 - FDA Regulatory Timeline and Events

ANAVEX®2-73 is a drug developed by Anavex Life Sciences for the following indication: For early Alzheimer's disease patients. 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.

ANAVEX®3-71 - FDA Regulatory Timeline and Events

ANAVEX®3-71 is a drug developed by Anavex Life Sciences for the following indication: For the treatment of neurodegenerative and neurodevelopmental disorders. 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.

Anavex Life Sciences FDA Events - Frequently Asked Questions

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

In the past two years, Anavex Life Sciences (AVXL) has reported FDA regulatory activity for the following drugs: ANAVEX 2-73 (blarcamesine), ANAVEX®3-71 and ANAVEX®2-73.

The most recent FDA-related event for Anavex Life Sciences occurred on May 1, 2025, involving ANAVEX®3-71. The update was categorized as "Enrollment Update," with the company reporting: "Anavex Life Sciences Corp announced the successful completion of enrollment in its Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia (ANAVEX3-71-SZ-001, NCT06245213)."

Current therapies from Anavex Life Sciences in review with the FDA target conditions such as:

  • Alzheimer's Disease - ANAVEX 2-73 (blarcamesine)
  • For the treatment of neurodegenerative and neurodevelopmental disorders - ANAVEX®3-71
  • For early Alzheimer's disease patients. - ANAVEX®2-73

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:AVXL) was last updated on 7/9/2025 by MarketBeat.com Staff
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