Takeda put $150 million into Denali Therapeutics in January 2018. Eight years later, it’s walking away.
The Japanese pharma returned all rights to DNL593—a frontotemporal dementia therapy—to Denali on April 3, citing “strategic considerations.” Not safety. Not efficacy. Strategy. That’s pharma code for “we changed our priorities.”
This wasn’t Takeda’s first exit from a Denali program. The two also ran DNL919, a TREM2 agonist for Alzheimer’s, which hit an FDA clinical hold in January 2022. The hold eventually lifted, but Takeda and Denali killed the program anyway in August 2023 after Phase 1 data showed only a “narrow therapeutic window.” Two shots at neurodegeneration, two write-offs.
The timing stings. Denali just got FDA approval for Avlayah—its Hunter syndrome therapy, the first in nearly 20 years—days before Takeda announced its exit. Like Avlayah, DNL593 is engineered to cross the blood-brain barrier. Denali is essentially proving the platform works while losing the partner who funded it.
CEO Ryan Watts says the company will advance DNL593 independently. Enrollment in the Phase 1/2 study is complete at 40 participants, no safety signals so far.
Going solo on a Phase 1/2 dementia program after losing a $150M backer. Phase 1/2 data before year-end 2026 will be the first real test of whether the platform holds without Takeda’s backing.
Diana Kowalski