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DNLI biotech catalysts & pipeline

DENALI THERAPEUTICS INC · Data as of 2026-09-08

Upcoming catalysts

DNL593 — Interim data

2026

Phase 2 Part B interim data in patients with FTD-GRN will read out in 2026
Source filing

TAK-594/DNL593 (PTV:PGRN) — Initial data

2026

Initial FTD- GRN patient data are expected in 2026.
Source filing

DNL151 (LRRK2 inhibitor) — Topline data

H1 2027

Data from BEACON are expected in the first half of 2027.
Source filing

DNL593 — Topline data

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 — Topline data

1H 2027

Denali expects data from this study in 1H 2027.
Source filing

DNL921 — Topline data

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

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