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SAR443820/DNL788

Amyotrophic Lateral Sclerosis (ALS)

Phase 2Active (HIMALAYA study)

Key Facts

Indication

Amyotrophic Lateral Sclerosis (ALS)

Phase

Phase 2

Status

Active (HIMALAYA study)

Company

Denali Therapeutics, Denali Therapeutics

About Denali Therapeutics

Denali Therapeutics is a public biotech company focused on discovering, developing, and delivering medicines for serious diseases, with a particular emphasis on crossing biological barriers to reach the brain. The company's proprietary TransportVehicle™ platform is central to its strategy, aiming to transform treatment for neurodegenerative and lysosomal storage disorders. Denali has built a diverse clinical-stage pipeline through both internal R&D and strategic partnerships, positioning itself at the forefront of next-generation CNS therapeutics. The company is headquartered in South San Francisco, California, and trades on the NASDAQ under the ticker DNLI.

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About Denali Therapeutics

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Therapeutic Areas

Neurodegenerative Diseases Lysosomal Storage Disorders Central Nervous System (CNS)

Other Amyotrophic Lateral Sclerosis (ALS) Drugs

Drug	Company	Phase	Status
Utreloxastat (PTC857)	PTC Therapeutics	Phase 2	Clinical
Pegcetacoplan	Apellis Pharmaceuticals	Phase 2	Active (MERIDIAN study)
RELYVRIO/ALBRIOZA (AMX0035)	Amylyx Pharmaceuticals	Approved/Commercial	Marketed
AMX0035	Amylyx Pharmaceuticals	Phase 3	Active (Confirmatory PHOENIX trial)
AMX0114	Amylyx Pharmaceuticals	Phase 1	Active
Taldefgrobep alfa	Biohaven	Phase 2/3	Completed
AMT-162	uniQure	Preclinical	Research
AAV-UPF1	MeiraGTx	Preclinical	Research stage
Tegoprubart	Eledon Pharmaceuticals	Phase 2	Phase 2 biomarker study completed; seeking financing for Phase 3
Intranasal Foralumab	Tiziana Life Sciences	Phase 2	Planned - Trial to begin 2H 2025 (Grant from ALS Association)
TDP-43 Program	Korro Bio	Discovery	Active
COYA 302	Coya Therapeutics	Phase 2	Active; CTA accepted in Canada