Denali Q4 2025 net loss $128.5M; tividenofusp alfa PDUFA date April 5, 2026

Denali Therapeutics Inc.

2025-FY EPS reported -$2.97

Q4 2025 net loss $128.5M vs $114.8M in Q4 2024; full year net loss $512.5M vs $422.8M in 2024.
PDUFA target action date for tividenofusp alfa (Hunter syndrome) BLA is April 5, 2026; commercial launch readiness established.
Preliminary Phase 1/2 data for DNL126 (Sanfilippo syndrome type A) support accelerated approval path; global Phase 3 planning ongoing.
Cash, cash equivalents and marketable securities as of Dec 31, 2025 were approximately $966.2M.
In December 2025, raised $275M synthetic royalty from Royalty Pharma and ~$200M net from public offering.

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