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