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Amylyx Pharmaceuticals, Inc. (AMLX)

Amylyx Pharmaceuticals, Inc. operates as a clinical-stage biopharmaceutical firm, primarily focused on creating therapies for amyotrophic lateral sclerosis (ALS) and various other neurodegenerative conditions. A key asset in its developmental pipeline is AMX0035, a proprietary dual UPR-Bax apoptosis inhibitor. This compound, which integrates sodium phenylbutyrate and taurursodiol, is under investigation for treating ALS, and its application is also being explored for other neurodegenerative diseases. The company was established in 2013 and is based in Cambridge, Massachusetts.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Amylyx Pharmaceuticals, Inc. logo

Amylyx Pharmaceuticals, Inc.

NASDAQ:AMLXHealthcare
+0.63%$28.86
AH$28.86+0.00%vs close
Mkt Cap$3.62B
Float96.37M
O/S125.51M
Vol
$ Vol
RVOL
Inst Own91.7%
SI13.8%
Earnings
Dilution
Amylyx Pharmaceuticals, Inc. logoNASDAQ:AMLX$28.86+0.63%
Phase Distribution
13 lead-sponsored trials·3 active·6 completed
Phase 11
Phase 1/21
Phase 24
Phase 2/32
Phase 33
Not applicable2
Status Overview
Recruiting1
Active, not recruiting2
Completed6
Expanded access2
Unknown2

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 3
    Unknown status

    Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment

    AMX0035

    Amyotrophic Lateral Sclerosis

    Enrollment
    664
    Start
    Oct 2021
    Primary Completion
    Jan 2024
    Completion
    Jan 2026est.
    NCT05021536
  • Phase 3
    Completed

    Extension Study Evaluating The Safety And Tolerability of AMX0035

    AMX0035

    Amyotrophic Lateral Sclerosis

    Enrollment
    352
    Start
    Dec 2022
    Primary Completion
    Oct 2024
    Completion
    Oct 2024
    NCT05619783
  • Phase 3
    Active, not recruiting

    Avexitide for Treatment of Post-Bariatric Hypoglycemia

    Avexitide

    Post Bariatric Hypoglycemia

    Enrollment
    75
    Start
    Apr 2025
    Primary Completion
    Jul 2026
    Completion
    Feb 2027est.
    NCT06747468
  • Phase 2/3
    Completed

    A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS)

    AMX0035

    Amyotrophic Lateral Sclerosis

    Enrollment
    28
    Start
    Nov 2020
    Primary Completion
    Dec 2022
    Completion
    Jan 2023
    NCT04516096
  • Phase 2/3
    Completed

    AMX0035 and Progressive Supranuclear Palsy

    AMX0035

    Progressive Supranuclear Palsy, PSP +2

    Enrollment
    139
    Start
    Dec 2023
    Primary Completion
    Sep 2025
    Completion
    Oct 2025
    NCT06122662
  • Phase 2
    Completed

    AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)

    AMX0035

    Amyotrophic Lateral Sclerosis, Motor Neuron Disease +6

    Enrollment
    137
    Start
    Jun 2017
    Primary Completion
    Sep 2019
    Completion
    Nov 2019
    NCT03127514
  • Phase 2
    Completed

    Open Label Extension Study of AMX0035 in Patients With ALS

    AMX0035

    Amyotrophic Lateral Sclerosis, ALS

    Enrollment
    90
    Start
    Mar 2018
    Primary Completion
    Mar 2021
    Completion
    Mar 2021
    NCT03488524
  • Phase 2
    Completed

    Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease

    AMX0035, Placebo

    Alzheimer Disease

    Enrollment
    95
    Start
    Sep 2018
    Primary Completion
    Oct 2020
    Completion
    Nov 2020
    NCT03533257
  • Phase 2
    Active, not recruiting

    AMX0035 in Adult Patients With Wolfram Syndrome

    AMX0035

    Wolfram Syndrome

    Enrollment
    12
    Start
    Mar 2023
    Primary Completion
    Jul 2024
    Completion
    May 2028est.
    NCT05676034
  • Phase 1/2
    Unknown status

    Pharmacokinetic and Pharmacodynamic Study of AMX0035 in Patients With ALS

    AMX0035

    ALS

    Enrollment
    14
    Start
    Aug 2021
    Primary Completion
    May 2022
    Completion
    Sep 2023est.
    NCT04987671
  • Phase 1
    Recruiting

    AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis

    AMX0114

    ALS

    Enrollment
    48
    Start
    Apr 2025
    Primary Completion
    Feb 2027est.
    Completion
    Oct 2027est.
    NCT06665165
  • Expanded access
    Approved for marketing

    An Intermediate Size Expanded Access Protocol of AMX0035 for ALS

    AMX0035

    Amyotrophic Lateral Sclerosis

    Enrollment
    -
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT05286372
  • Expanded access
    Available

    An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia

    Avexitide

    Post-bariatric Hypoglycemia

    Enrollment
    -
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT07582874
Search ClinicalTrials.gov for “Amylyx Pharmaceuticals”