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Form 8-K · Current Report · Filed 2025-08-21

FDA Approves DAWNZERA for HAE Prophylaxis

Ionis Pharmaceuticals announced that the FDA has approved DAWNZERA (donidalorsen) for prophylaxis to prevent HAE attacks in adults and pediatric patients 12 years of age and older.

Filer
Ionis Pharmaceuticals Inc. IONS · NASDAQ
Filed
Accession
0001140361-25-032176
CIK
0000874015
Signal
High impactHealthcare

Details

DAWNZERA, the first RNA-targeted medicine for HAE, demonstrated significant and sustained HAE attack rate reduction, with dosing options every 4 or 8 weeks. The approval was based on positive results from the Phase 3 OASIS-HAE study and ongoing OASISplus open-label extension study. DAWNZERA will be available in the U.S. in the coming days.

Items reported

Item 7.01

Regulation FD Disclosure

Regulation FD Disclosure
Item 8.01

Other Events

Regulatory Approval
Item 9.01

Financial Statements and Exhibits

Exhibits Furnished

Market reaction

Close before filing

$42.81

Next session

-0.3%

Since filing

+20.9%

Latest close

$51.77

What happened, not what will happen — closing prices around the filing date.

Precedent

Previous filings from IONS reporting the same item, with the next session's move:

Exhibits (1)

About Ionis Pharmaceuticals Inc.

Ionis Pharmaceuticals Inc. is a biotechnology company focused on discovering and developing RNA-targeted therapeutics. The primary mission of Ionis is to harness its expertise in antisense oligonucleotide technology to address complex genetic disorders. Ionis is pioneering in the field of RNA-targeted drug discovery, aiming to treat a wide range of diseases, including neurological, cardiovascular, metabolic, and cancer-related conditions. Notably, the company has a robust pipeline of drugs in various stages of development and partnerships with leading pharmaceutical companies to expand the reach and impact of its therapeutic discoveries. As an innovative entity in the biotechnology sector, Ionis Pharmaceuticals plays a significant role in advancing medical treatments that target the underlying genetic causes of diseases, thereby offering new hope and potential solutions to patients worldwide. Its advancements contribute substantially to the growth and evolution of personalized medicine, emphasizing the importance of genetic research in modern healthcare.

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