DNLI · Denali Therapeutics Inc.

Denali Therapeutics announced that Takeda Pharmaceutical Company Limited has decided to terminate the Collaboration Agreement dated January 3, 2018, for the co-development and co-commercialization of DNL593 (PTV:PGRN). The termination notice was received on April 3, 2026, and will become effective 60 days later. Takeda cited strategic considerations as the driver for the decision, explicitly stating it was unrelated to efficacy or safety data. This distinction is critical for investors, as it suggests the decision reflects Takeda's portfolio prioritization rather than a fundamental flaw in the asset.

Upon effectiveness, all rights to the DNL593 program will revert to Denali, including its intellectual property portfolio. Denali stated it will have no further financial obligations to Takeda. The company plans to continue the clinical development of DNL593 independently. The investigational therapy, which utilizes Denali's TransportVehicle™ technology to deliver progranulin across the blood-brain barrier for the treatment of FTD-GRN, has completed enrollment with 40 participants. Denali expects to report results from the ongoing Phase 1/2 study by the end of 2026. Interim results from Part A in healthy volunteers demonstrated dose-dependent increases in cerebrospinal fluid progranulin levels and a generally well-tolerated safety profile.