earnings
confidence high
sentiment neutral
materiality 0.75
Denali Q2 net loss $99M; FDA open to accelerated approval for DNL310; regains ATV:Abeta rights
Denali Therapeutics Inc.
2024-Q2 EPS reported
-$1.26
- Net loss $99.0M in Q2 2024 vs $183.4M net income in Q2 2023; no collaboration revenue versus $294.1M last year.
- Cash and marketable securities $1.35B as of June 30, 2024.
- FDA CDER open to discussing accelerated approval for DNL310 (MPS II) using CSF HS as surrogate biomarker.
- Biogen terminated ATV:Abeta license; Denali regains all rights; decision not related to efficacy or safety.
- DNL126 (MPS IIIA) selected for FDA START pilot program; Phase 1/2 data expected by end of 2024.