Takeda Terminates Denali Partnership, Returns DNL593 Dementia Asset Amid Restructuring

Takeda terminated its collaboration with Denali Therapeutics on April 3, 2026, returning full rights to the dementia drug DNL593 for frontotemporal dementia-granulin (FTD-GRN). 125

The decision was driven by strategic considerations as part of Takeda's restructuring, which includes layoffs and aims to save $1.26 billion by 2028, and is not related to safety or efficacy concerns. 1245

The partnership originated in 2018 to develop up to three neurodegenerative drugs; a prior Alzheimer's asset (DNL919) was discontinued in 2023 after FDA issues and Phase 1 data. 12

Denali plans to advance DNL593 independently, with Phase 1/2 trial results expected by the end of 2026; enrollment is complete with no safety signals reported. 12345

Denali recently gained FDA approval for Avlayah (tividenofusp alfa), its Hunter syndrome therapy using similar blood-brain barrier technology. 12

Sources:

1. https://www.fiercebiotech.com/biotech/takeda-tears-denali-partnership-returning-dementia-asset-amid-restructuring

2. https://www.biospace.com/deals/takeda-breaks-up-with-denali-dumps-dementia-drug

3. https://www.morningstar.com/news/dow-jones/202604032469/takeda-ends-denali-therapeutics-dementia-drug-partnership

4. https://www.pharmanow.live/latest-news/denali-dnl593-dementia

5. https://www.stocktitan.net/sec-filings/DNLI/8-k-denali-therapeutics-inc-reports-material-event-10bd64406f1a.html