Frontotemporal dementia with GRN mutations
DNLIDenali TherapeuticsCatalyst overview
Research summary
This catalyst tracks a Phase 1/2 data readout for TAK-594/DNL593 (PTV:PGRN) in Frontotemporal dementia with GRN mutations . The expected timing is based on the latest available company guidance and may change.
Collab w/ Takeda. 11/2022- Interim Part A data reported. Part A data at AAIC '23. 02/27/24- Part B voluntarily paused and will resume in 2024. 11/06/25:- Trial ongoing. 02/26/26:- Ph1/2 FTD-GRN trial fully enrolled 40 participants; initial patient data expected in 2026. 05/07/26:- Takeda collaboration ended; Denali now holds full rights; fully enrolled Ph1/2 FTD-GRN trial results expected end-2026. 08/06/26:- FDA granted Orphan Drug Designation; Ph1/2 results delayed to 2027.
Verification
Confirm timing and program details against the company announcement or filing.