Ionis Pharmaceuticals

Ionis Pharmaceuticals received FDA approval for Tryngolza (olezarsen) to treat familial chylomicronemia syndrome (FCS). Tryngolza, an RNA-targeted medicine, significantly reduces triglyceride levels and offers a clinically meaningful reduction in acute pancreatitis events when used with a low-fat diet. The approval was based on positive data from the Phase 3 Balance trial, showing a 42.5% reduction in triglycerides at six months and a 57% reduction at 12 months. Ionis is launching the Ionis Every Step initiative to support patients and healthcare providers.

Ionis Pharmaceuticals' TRYNGOLZA™ (olezarsen) gains FDA approval for familial chylomicronemia syndrome (FCS), marking the first U.S. treatment for the rare disease. TRYNGOLZA, used with a low-fat diet, significantly reduces triglycerides and acute pancreatitis risk. Ionis anticipates this as the first of four product launches in three years. The approval is based on the Phase 3 Balance trial results, published in The New England Journal of Medicine.

Ionis Pharmaceuticals' TRYNGOLZA, approved by the FDA for Familial Chylomicronemia Syndrome, showed a 30.0% triglyceride reduction in Phase 3 trials. Priced at $595,000 annually, it aligns with rare-disease drug pricing. Needham maintains a Buy rating, anticipating future SHTG indication approval could impact pricing and market.

FDA approves TRYNGOLZA™ (olezarsen) to reduce triglycerides and acute pancreatitis events in adults with familial chylomicronemia syndrome (FCS). TRYNGOLZA is self-administered monthly and represents a significant advancement for FCS treatment.

FDA approves TRYNGOLZA™ (olezarsen) to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), significantly lowering triglyceride levels and acute pancreatitis events. TRYNGOLZA is self-administered monthly and marks a transformative treatment for FCS patients.

The FDA approved olezarsen (TRYNGOLZA) as the first-ever therapy to reduce triglycerides and acute pancreatitis events in adults with familial chylomicronemia syndrome (FCS). Olezarsen, an RNA-targeted medicine, significantly lowers triglycerides and decreases the risk of acute pancreatitis when used with a low-fat diet. The approval is based on the BALANCE trial, which showed significant reductions in triglyceride levels with olezarsen treatment.

The FDA approved olezarsen (Tryngolza), the first treatment for familial chylomicronemia syndrome (FCS), a rare genetic condition causing high triglyceride levels. Olezarsen, taken monthly with a low-fat diet, blocks APOC-III to help break down fats, reducing triglycerides. It's available as an autoinjector for patient or caregiver use.

H.C. Wainwright analyst Patrick Trucchio sees FDA approval of Ionis Pharmaceuticals’ Tryngolza as positive for Arrowhead’s plozasiran, predicting its approval by 2025. With superior efficacy and dosing, plozasiran could become standard care for familial chylomicronemia syndrome. Arrowhead is rated Buy with an $80 target.

Ionis Pharmaceuticals won FDA approval for Tryngolza (olezarsen) to treat familial chylomicronemia syndrome, based on trial results showing lowered triglyceride levels and safety. The drug may also benefit patients with high triglycerides, potentially generating $1.8 to $2 billion in peak sales.