Denali Q3 net loss $107.2M; tividenofusp BLA planned early 2025; DNL126 shows biomarker reduction

Denali Therapeutics Inc.

2024-Q3 EPS reported -$1.89

Net loss $107.2M vs $99.4M YoY; no collaboration revenue; cash $1.28B at Sep 30, 2024.
Updated 2024 cash opex guidance: +5-10% vs 2023 (prior: ≤2023) due to BLA prep and commercial readiness.
Tividenofusp alfa (MPS II): FDA agrees CSF HS as surrogate endpoint; BLA submission on track for early 2025.
DNL126 (MPS IIIA): preliminary data show CSF HS reduction and normalization; study expanded for accelerated path.
SAR443820/DNL788 (MS): Sanofi's K2 Phase 2 discontinued after missing primary and key secondary endpoints.

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