Denali Therapeutics Inc. DNLI develops therapies targeting neurodegenerative diseases. The company owns an impressive pipeline of targeted therapeutic candidates for neurodegenerative diseases. Its recent pipeline progress has been encouraging.
Denali’s strategic partnerships with bigwigs like Biogen BIIB and Sanofi SNY provide funds for pipeline development.
Denali and Biogen are developing BIIB122/DNL151, a small-molecule inhibitor, of LRRK2 for Parkinson’s disease (“PD”).
Earlier this month, Denali outlined key milestones related to its pipeline development that it looks to achieve through 2024.
The phase IIb LUMA study, which is being conducted by BIIB, is evaluating BIIB122/DNL151 in early-stage PD with and without LRRK2 mutations and is expected to progress.
Denali has partnered with Sanofi to develop SAR443820/DNL788 in amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”) indications.
Sanofi plans to announce top-line data from the phase II HIMALAYA study, evaluating SAR443820/DNL788 for treating ALS, in the first half of 2024. The K2 phase II study on SAR443820/DNL788 in MS is expected to continue.
Meanwhile, eclitasertib (SAR443122/DNL758), which is being solely developed by SNY, is being evaluated in a phase II study for treating ulcerative colitis.
This apart, Denali’s wholly-owned candidates in late-stage development programs include tividenofusp alfa (DNL310) for treating MPS II (Hunter syndrome) and DNL343 for treating ALS.
The company plans to complete enrollment in the phase II/III COMPASS study investigating tividenofusp alfa in MPS II in 2024.
DNLI also aims to complete the enrollment of participants in regimen G (DNL343) of the phase II/III HEALEY ALS Platform study in 2024.
Denali does not have any approved products in its portfolio yet, and hence, any pipeline setback will be detrimental to its growth prospects. Also, the neurodegenerative field is characterized by intense and increasing competition. Denali’s high dependence on its partners for financial resources remains an overhang.
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