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Amylyx Pharmaceuticals (AMLX) FDA Events

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FDA Events for Amylyx Pharmaceuticals (AMLX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Amylyx Pharmaceuticals (AMLX). Over the past two years, Amylyx Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AMX0035 and AMX0114. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Amylyx Pharmaceuticals' Drugs in FDA Review

AMX0035 - FDA Regulatory Timeline and Events

AMX0035 is a drug developed by Amylyx Pharmaceuticals for the following indication: To treat amyotrophic lateral sclerosis (ALS). 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.

AMX0114 - FDA Regulatory Timeline and Events

AMX0114 is a drug developed by Amylyx Pharmaceuticals for the following indication: Treatment of Amyotrophic Lateral Sclerosis. 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.

Amylyx 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, Amylyx Pharmaceuticals (AMLX) has reported FDA regulatory activity for the following drugs: AMX0035 and AMX0114.

The most recent FDA-related event for Amylyx Pharmaceuticals occurred on June 3, 2025, involving AMX0114. The update was categorized as "Designation Grant," with the company reporting: "Amylyx Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AMX0114, an investigational antisense oligonucleotide (ASO) targeting calpain-2 for the treatment of people living with amyotrophic lateral sclerosis (ALS)."

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

  • To treat amyotrophic lateral sclerosis (ALS) - AMX0035
  • Treatment of Amyotrophic Lateral Sclerosis - AMX0114

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