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AMX0035

Amyotrophic Lateral Sclerosis (ALS)

Phase 3Active (Confirmatory PHOENIX trial)NCT05021536

Key Facts

Indication
Amyotrophic Lateral Sclerosis (ALS)
Phase
Phase 3
Status
Active (Confirmatory PHOENIX trial)
Company

About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals is dedicated to creating new possibilities for people living with debilitating neurodegenerative diseases by targeting key cellular pathways of neurodegeneration. The company achieved a landmark success with the U.S. FDA approval of RELYVRIO (AMX0035) for ALS in September 2022, transitioning from a clinical-stage to a commercial-stage entity. Its strategy involves maximizing the global potential of RELYVRIO while advancing its next-generation candidate, AMX0114, and exploring the application of its dual-mechanism platform in other diseases like Wolfram syndrome and progressive supranuclear palsy (PSP). Amylyx faces the critical challenge of commercial execution and confirming the clinical benefit of its lead asset in an ongoing confirmatory trial.

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About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals is dedicated to creating new possibilities for people living with debilitating neurodegenerative diseases by targeting key cellular pathways of neurodegeneration. The company achieved a landmark success with the U.S. FDA approval of RELYVRIO (AMX0035) for ALS in September 2022, transitioning from a clinical-stage to a commercial-stage entity. Its strategy involves maximizing the global potential of RELYVRIO while advancing its next-generation candidate, AMX0114, and exploring the application of its dual-mechanism platform in other diseases like Wolfram syndrome and progressive supranuclear palsy (PSP). Amylyx faces the critical challenge of commercial execution and confirming the clinical benefit of its lead asset in an ongoing confirmatory trial.

View full company profile

About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals is dedicated to creating new possibilities for people living with debilitating neurodegenerative diseases by targeting key cellular pathways of neurodegeneration. The company achieved a landmark success with the U.S. FDA approval of RELYVRIO (AMX0035) for ALS in September 2022, transitioning from a clinical-stage to a commercial-stage entity. Its strategy involves maximizing the global potential of RELYVRIO while advancing its next-generation candidate, AMX0114, and exploring the application of its dual-mechanism platform in other diseases like Wolfram syndrome and progressive supranuclear palsy (PSP). Amylyx faces the critical challenge of commercial execution and confirming the clinical benefit of its lead asset in an ongoing confirmatory trial.

View full company profile

Other Amyotrophic Lateral Sclerosis (ALS) Drugs

DrugCompanyPhase
Utreloxastat (PTC857)PTC TherapeuticsPhase 2
SAR443820/DNL788Denali TherapeuticsPhase 2
PegcetacoplanApellis PharmaceuticalsPhase 2
RELYVRIO/ALBRIOZA (AMX0035)Amylyx PharmaceuticalsApproved/Commercial
AMX0114Amylyx PharmaceuticalsPhase 1
Taldefgrobep alfaBiohavenPhase 2/3
AMT-162uniQurePreclinical
AAV-UPF1MeiraGTxPreclinical
TegoprubartEledon PharmaceuticalsPhase 2
Intranasal ForalumabTiziana Life SciencesPhase 2
TDP-43 ProgramKorro BioDiscovery
COYA 302Coya TherapeuticsPhase 2