Denali Therapeutics Regains Full Control of DNL593
Denali Therapeutics (DNLI) announced that it has received notification from Takeda (TAK) of its decision to terminate the collaboration agreement between the two companies to co-develop and co-commercialize DNL593. The decision was driven by strategic considerations and is not related to efficacy or safety data. DNL593 is an investigational progranulin replacement therapy utilizing Denali's Protein TransportVehicle to deliver progranulin across the blood-brain barrier to the brain for the treatment of frontotemporal dementia-granulin. Denali has led development activities and will regain full control of DNL593 and its intellectual property portfolio. "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 devasting disease."