TAK-594/DNL593 (PTV:PGRN) — Initial data
2026
Initial FTD- GRN patient data are expected in 2026.Source filing
DNLI biotech catalysts & pipeline
DENALI THERAPEUTICS INC · Data as of 2026-10-25
Upcoming catalysts
DNL151 (LRRK2 inhibitor) — Clinical data readout
H1 2027
Data from BEACON are expected in the first half of 2027.Source filing
DNL593 — Clinical data readout
in 2027
Denali now expects results from the study in 2027, updated from its prior expectation of results by the end of 2026.Source filing
DNL628 — Initial data
H1 2027
Initial clinical biomarker data from the ongoing Phase 1b study of DNL628 in participants with Alzheimer's disease are expected in the first half of 2027.Source filing
DNL921 — Clinical data readout
in 2027
Safety and clinical proof-of-concept data from the ongoing Phase 1/1b study of DNL921 in healthy volunteers and participants with Alzheimer's disease are expected in 2027.Source filing
DNL952 — Initial data
in 2027
Dosing of participants with late-onset Pompe disease began in the Phase 1 study of DNL952 in the second quarter of 2026, and initial clinical data are expected in 2027.Source filing
zafinofusp alfa (DNL126; ETV:SGSH) — NDA/BLA submission
in 2027
Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for zafinofusp alfa for Sanfilippo syndrome type A in 2027.Source filing