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Alector (ALEC) FDA Events

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FDA Events for Alector (ALEC)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Alector (ALEC). Over the past two years, Alector has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AL001, AL002, AL101, and Latozinemab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Alector's Drugs in FDA Review

AL001 - FDA Regulatory Timeline and Events

AL001 is a drug developed by Alector for the following indication: A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder 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.

AL002 (INVOKE-2) - FDA Regulatory Timeline and Events

AL002 (INVOKE-2) is a drug developed by Alector for the following indication: 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.

AL101 - FDA Regulatory Timeline and Events

AL101 is a drug developed by Alector for the following indication: Healthy volunteers. 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.

Latozinemab - FDA Regulatory Timeline and Events

Latozinemab is a drug developed by Alector for the following indication: Treatment for FTD-GRN. 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.

Alector FDA Events - Frequently Asked Questions

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

In the past two years, Alector (ALEC) has reported FDA regulatory activity for the following drugs: AL001, AL101, AL002 (INVOKE-2) and Latozinemab.

The most recent FDA-related event for Alector occurred on May 29, 2025, involving AL001. The update was categorized as "Dosing Update," with the company reporting: "Alzamend Neuro, Inc. announced the dosing of the first patient of its first Phase II clinical study of AL001, in healthy human subjects. This study follows the successful development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial."

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

  • A Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients - AL001
  • Healthy volunteers - AL101
  • Early Alzheimer's Disease - AL002 (INVOKE-2)
  • Treatment for FTD-GRN. - Latozinemab

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:ALEC) was last updated on 7/10/2025 by MarketBeat.com Staff
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