Denali Therapeutics announced that Takeda has terminated its collaboration agreement to co‑develop and co‑commercialize the DNL593 progranulin replacement therapy for frontotemporal dementia‑granulin (FTD‑GRN). The termination, effective June 2 2026, was driven by strategic considerations and not by efficacy or safety data, and it leaves Denali with full ownership of the program’s intellectual property and all future development responsibilities.
The collaboration began in January 2018, with Takeda exercising its option to co‑develop and co‑commercialize DNL593 in November 2021. Takeda’s exit reflects a shift in its strategic focus, while Denali will now control all aspects of the DNL593 program, including regulatory, clinical, and commercialization pathways, and will have no further financial obligations to Takeda.
Enrollment in the Phase 1/2 study is complete with 40 participants. Interim data from healthy volunteers show dose‑dependent increases in cerebrospinal fluid progranulin and generally favorable tolerability, supporting the program’s scientific rationale. Denali plans to report the Phase 1/2 results by the end of 2026.
"While we have greatly valued our partnership, we are pleased to regain full ownership of DNL593. We remain confident in the scientific rationale and the data generated to date, and we look forward to advancing DNL593 independently. We plan to report results from the ongoing Phase 1/2 trial by the end of 2026," said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. "Our TransportVehicle platform is the first FDA‑approved blood‑brain barrier‑crossing technology, enabling a robust portfolio with broad potential across neurodegenerative diseases like frontotemporal dementia, where there are no currently approved treatment options to slow the progression of this devastating disease." "These data show that single doses of DNL593 result in substantial increases in CSF progranulin levels suggesting brain delivery of DNL593 was achieved and has the potential to address progranulin deficiency, which drives disease progression in people living with FTD‑GRN," said Carole Ho, M.D., Chief Medical Officer at Denali.
Denali’s TransportVehicle™ platform, which facilitates delivery of therapeutics across the blood‑brain barrier, is a core differentiator in its pipeline. By regaining full control of DNL593, Denali concentrates both the risks and the potential upside of the asset, positioning itself to accelerate development and commercialization without external partnership constraints. The company’s current financial profile—$0 revenue and a recent net loss of $512.54 million—highlights the importance of efficient capital allocation, and the independent development of DNL593 represents a strategic focus on high‑impact neurodegenerative indications.
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