regulatory
confidence high
sentiment positive
materiality 0.90
FDA approves Ionis' DAWNZERA (donidalorsen) for HAE prophylaxis in patients 12+
IONIS PHARMACEUTICALS INC
- First and only RNA-targeted HAE medicine; self-administered every 4 or 8 weeks via autoinjector.
- Phase 3 OASIS-HAE: Q4W reduced monthly attack rate 81% vs placebo (primary endpoint); 87% from second dose.
- OASISplus OLE: 94% attack rate reduction after one year; switch cohort reduced attacks 62% vs prior therapy.
- Ionis' second independent launch in nine months; 84% of patients surveyed preferred DAWNZERA over prior treatment.
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