Denali regains full rights to brain therapy after Takeda ends partnership

Denali Therapeutics Inc. (NASDAQ: DNLI) announced that Takeda has terminated their collaboration agreement for DNL593, an investigational therapy for frontotemporal dementia-granulin. The decision was based on strategic considerations and not related to efficacy or safety data, according to the company's statement.

DNL593 uses Denali's Protein TransportVehicle technology to deliver progranulin across the blood-brain barrier for treating FTD-GRN, a genetic form of frontotemporal dementia. Denali will regain full control of the therapy and its intellectual property portfolio.

The company expects to report results from its ongoing Phase 1/2 study by the end of 2026. The trial has completed enrollment with 40 participants diagnosed with FTD-GRN. Interim results from the study's first part showed dose-dependent increases in cerebrospinal fluid progranulin levels in healthy volunteers, indicating the therapy reaches the brain. The treatment was generally well tolerated with no significant safety signals reported.

"We remain confident in the scientific rationale and the data generated to date, and we look forward to advancing DNL593 independently," said Ryan Watts, Chief Executive Officer of Denali Therapeutics.

Frontotemporal dementia is the most common form of dementia in people under 60 years old. Mutations in the granulin gene that reduce progranulin protein levels are among the most common genetic causes of FTD. No approved medications currently exist to stop or slow the progression of FTD or FTD-GRN.

Denali's TransportVehicle platform is designed to deliver therapeutic molecules to the brain by crossing the blood-brain barrier. The company states five programs using this technology are currently in clinical development.

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