Denali completes BLA submission for Hunter syndrome; Q1 net loss widens to $133M

Denali Therapeutics Inc.

2025-Q1 EPS reported -$0.78

Net loss of $133.0M in Q1 2025 vs $101.8M in Q1 2024; R&D expense rose to $116.2M.
Cash and marketable securities $1.05B as of March 31, 2025.
BLA for tividenofusp alfa (Hunter syndrome) submitted under FDA accelerated approval pathway.
Phase 2b LUMA study for BIIB122 (Parkinson's) fully enrolled; readout expected in 2026.
G&A expenses increased to $29.4M from $25.2M, driven by BLA submission and launch prep.

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