Denali Therapeutics Inc.·Healthcare

Denali Therapeutics (DNLI) maintains a "Strong Buy" rating following FDA Accelerated Approval of AVLAYAH for Hunter Syndrome and robust pipeline momentum. Company's DNL593 for FTD-GRN is differentiated by restoring both extracellular and lysosomal PGRN; phase 1/2 data readout expected by end of 2026. AVLAYAH's full approval depends on confirmatory COMPASS study results; commercial performance remains unproven post-April 2026 launch.

DNLI sinks after BIIB122 failed a mid-stage Parkinson's study, prompting Denali and Biogen to halt development in idiopathic cases.

This biotech develops therapies for neurodegenerative diseases, advancing a broad pipeline through strategic pharmaceutical partnerships.

Denali Therapeutics NASDAQ: DNLI is seeing early commercial interest for its first approved drug, AVLAYAH, following its March 24 accelerated approval for Hunter syndrome, Chief Operating Officer and Chief Financial Officer Alexander Schuth said at a Bank of America Securities conference.

Denali Therapeutics Inc. (DNLI) Presents at Bank of America Global Healthcare Conference 2026 Transcript

Denali narrows its Q1 loss and gains FDA approval for Avlayah, the first new Hunter syndrome treatment option in nearly 20 years.
Denali Therapeutics Inc., a biopharmaceutical company, discovers and develops therapeutic candidates for neurodegenerative diseases in the United States. It offers leucine-rich repeat kinase 2 (LRRK2) inhibitor product candidate, including BIIB122/DNL151, a small molecule inhibitor, which is in phase I and phase Ib clinical trials for the treatment of Parkinson's disease. The company also develops DNL310 that is in Phase I/II clinical trials for the treatment of hunter syndrome; DNL343, which is in phase 1 clinical trial the treatment of amyotrophic lateral sclerosis (ALS); AR443820/DNL788 completed a phase I clinical trial for the treatment of ALS, multiple sclerosis (MS), and Alzheimer's disease; and SAR443122/DNL758, which is in phase II clinical trial for the treatment of cutaneous lupus erythematosus. It has collaboration agreement with Takeda Pharmaceutical Company, Genentech, Inc., Sanofi, F-star Gamma Limited, F-star Biotechnologische Forschungs-Und Entwicklungsges M.B.H, F-star Biotechnology Limited, SIRION Biotech GmbH, Genzyme Corporation, Harvard University, the Michael J. Fox Foundation, and Centogene; and a research and option agreement with Secarna Pharmaceuticals GmbH & Co. KG. to develop antisense therapies in the field of neurodegenerative diseases. The company was formerly known as SPR Pharma Inc. and changed its name to Denali Therapeutics Inc. in March 2015. Denali Therapeutics Inc. was incorporated in 2013 and is headquartered in South San Francisco, California.
Healthcare
Biotechnology
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2017-12-08
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