DAWNZERA™ (donidalorsen) approved in the European Union for hereditary angioedema (HAE)
Ionis Pharmaceuticals, Inc. (IONS)
Last ionis pharmaceuticals, inc. earnings: 2/26 07:00 am
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Source: Business Wire
CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the European Commission (EC) has approved DAWNZERA™ (donidalorsen) in the European Union (EU) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The approval follows the positive opinion of the Committee for Medicinal Products for Human Use.The approval is based on positive results from the Phase 3 OASIS-HAE and OASISplus studies, in which DAWNZERA demonstrated positive results across multiple measures of disease including significant and sustained reduction in mean monthly HAE attack rate, with 94% overall mean monthly attack rate reduction at one year in the OASISplus open-label extension study. DAWNZERA is self-administered via subcutaneous autoinjector every four or eight weeks.“The EU approval of DAWNZERA is an important milestone that reflects our ongoing
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IONS
Earnings
- 10/29/25 - Beat
IONS
Sec Filings
- 1/23/26 - Form 4
- 1/23/26 - Form 144/A
- 1/22/26 - Form 144
- IONS's page on the SEC website