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DNL343

Amyotrophic Lateral Sclerosis (ALS)

Phase 2/3Active

Key Facts

Indication

Amyotrophic Lateral Sclerosis (ALS)

Phase

Phase 2/3

Status

Active

Company

Denali Therapeutics

About Denali Therapeutics

Denali Therapeutics is on a mission to defeat neurodegeneration by creating medicines that cross biological barriers, particularly the blood-brain barrier. Founded in 2015, the company has established its proprietary TransportVehicle™ (TV) platform as a core competitive moat, enabling the delivery of therapeutic antibodies, enzymes, and other biologics into the central nervous system. Its strategy leverages this platform to build a broad pipeline targeting diseases like Parkinson's, Alzheimer's, ALS, and lysosomal storage disorders, with key programs advancing through mid- to late-stage clinical trials. Denali has secured major partnerships with industry leaders like Biogen and Takeda, validating its approach and providing non-dilutive capital to fuel its ambitious R&D agenda.

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Therapeutic Areas

Neurodegenerative Diseases Lysosomal Storage Disorders

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