Form 8-K · Current Report · Filed 2026-06-24
Ionis Pharmaceuticals Receives FDA Approval for TRYNGOLZA to Treat Severe Hypertriglyceridemia
Ionis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZA (olezarsen) as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG). The approval is based on positive results from the Phase 3 CORE and CORE2 studies, which demonstrated significant reductions in triglycerides and acute pancreatitis events. TRYNGOLZA is available in a 50 mg or 80 mg dose and is self-administered once monthly via an autoinjector. The drug will be available for sHTG in the U.S. in July.
- Filer
- Ionis Pharmaceuticals Inc. IONS · NASDAQ
- Filed
- Accession
- 0001140361-26-026232
- CIK
- 0000874015
- Signal
- High impactHealthcare
- Source
- Official filing on sec.gov ↗
Items reported
Reported Item
Market reaction
Close before filing
$75.99
Next session
+3.1%
Since filing
-31.9%
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:
Insider tape
Within 45 days of this filing, IONS insiders reported 77 Form 4 transactions — net selling of $8.4M.
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.
Never miss another IONS filing
Profitelligence watches EDGAR around the clock and alerts you within seconds.