Denali Q3 net loss $126.9M; tividenofusp alfa PDUFA extended to April 2026

Denali Therapeutics Inc.

2025-Q3 EPS reported -$2.24

Net loss $126.9M vs $107.2M in Q3 2024; cash $872.9M at Sept 30, 2025.
FDA extended PDUFA date for tividenofusp alfa BLA from Jan 5 to April 5, 2026; no new data requested.
Completed enrollment in Phase 1/2 study of DNL126 for MPS IIIA; planning global confirmatory study.
Submitted CTA for DNL628 (Alzheimer's) and IND for DNL952 (Pompe); new pipeline programs.
CMO Carole Ho departing; Peter Chin appointed Acting CMO; Tim Van Hauwermeiren joins Board.

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