Ionis announces positive Phase 3 results for donidalorsen in HAE; NDA submission planned

IONIS PHARMACEUTICALS INC

Donidalorsen met primary endpoint: significant reduction in HAE attack rate for Q4W (p<0.001) and Q8W (p=0.004) vs placebo.
Favorable safety profile; no serious adverse events in donidalorsen-treated patients.
Ionis preparing NDA submission to U.S. FDA; Otsuka preparing MAA to European Medicines Agency.
Third positive Phase 3 readout in 12 months, underscoring LICA platform strength.
Over 90% of OASIS-HAE patients completed and entered OASIS-Plus open-label extension study.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.