Denali Q2 net loss $124M; FDA priority review for Hunter syndrome BLA, DNL126 accelerated path aligned

Denali Therapeutics Inc.

FDA accepted tividenofusp alfa BLA for priority review; PDUFA target action date January 5, 2026.
FDA agreed CSF HS may be surrogate endpoint for accelerated approval of DNL126 in Sanfilippo syndrome; Phase 1/2 nearing completion.
Net loss $124.1M for Q2 2025 vs $99.0M in Q2 2024; R&D expenses $102.7M vs $91.4M.
Cash, cash equivalents, and marketable securities $977.4M as of June 30, 2025.
Preclinical ATV:Abeta data published in Science; company on track to file 1-2 IND applications in 2025.

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