Ionis Pharmaceuticals stock rises after positive EU regulatory opinion

Investing.com -- Ionis Pharmaceuticals Inc (NASDAQ:IONS) stock rose 3.1% on Friday following a positive regulatory development for its hereditary angioedema treatment in Europe.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for DAWNZERA (donidalorsen) for the routine prevention of recurrent attacks of hereditary angioedema in adults and adolescents aged 12 years and older. The opinion has been referred to the European Commission for a final approval decision.

DAWNZERA is designed to treat hereditary angioedema (HAE), a rare genetic condition causing potentially life-threatening swelling attacks affecting approximately 1 in 50,000 people worldwide. The CHMP recommendation was based on positive results from the Phase 3 OASIS-HAE and OASISplus studies, which demonstrated significant and sustained reduction in monthly HAE attack rates.

"We believe the positive opinion from the CHMP reflects the robust clinical evidence supporting DAWNZERA and its potential to deliver a meaningful benefit to people living with HAE in the EU," said Brett P. Monia, CEO of Ionis.

The treatment already received approval from the U.S. Food and Drug Administration in August 2025 for the same indication. Otsuka Pharmaceutical holds exclusive rights to commercialize donidalorsen across Europe and Asia Pacific regions as part of a partnership with Ionis.

If approved by the European Commission, DAWNZERA would provide a new treatment option for HAE patients in the European market.

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