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AMX0035 (RELYVRIO/ALBRIOZA)

Amyotrophic Lateral Sclerosis (ALS)

Approved / Phase 3ActivePHOENIX (Confirmatory)

Key Facts

Indication

Amyotrophic Lateral Sclerosis (ALS)

Phase

Approved / Phase 3

Status

Active

Company

Amylyx Pharmaceuticals

About Amylyx Pharmaceuticals

Amylyx Pharmaceuticals is a commercial-stage biotech focused on developing novel therapies for neurodegenerative and metabolic diseases with significant unmet medical needs. Its foundational achievement is the FDA and Health Canada approval of AMX0035 (RELYVRIO/ALBRIOZA) for ALS, secured via accelerated approval based on Phase 2 data. The company's strategy leverages a modality-agnostic R&D approach to match investigational drugs with diseases where they can have the greatest mechanistic impact, as seen in its expanding pipeline which now includes a first-in-class GLP-1 antagonist for hypoglycemia and an antisense oligonucleotide for ALS. Amylyx is transitioning from a single-product company to a diversified portfolio player while navigating the critical confirmatory trial for its lead asset.

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Therapeutic Areas

Neurodegenerative Diseases Metabolic Disorders Rare Diseases

Other Amyotrophic Lateral Sclerosis (ALS) Drugs

Drug	Company	Phase	Status
NPT520-34	Neuropore Therapies	Pre-clinical/Phase 1	Partnered (Biogen), Active
CNM-Au8	Clene	Phase 2/3	Active
Masitinib	AB Science	Phase 3	Active
SLS-005	Seelos Therapeutics	Platform Trial	Active (HEALEY ALS Platform Trial – Regimen E)
nAV-101	nVector	Pre-clinical	Active
ALTA-808	Alteron Therapeutics	Preclinical	IND-enabling studies launching
GM6	Genervon Biopharmaceuticals	Phase 2	Active
Lou Gehrig’s disease	Genclis	Discovery	Active
Treg-directed therapy for ALS	Iltoo Pharma	Pre-clinical	Active
NG CELL	NeuroGenesis Bio	Phase 2	Active
NP001	Neuvivo	Phase 3	Active
BREN02 / hEN1	BrainEver	Pre-clinical	Active