Business
Ionis well-positioned for continued momentum and substantial value creation in 2026 with two new independent launches and several pivotal data readouts
– TRYNGOLZA® (olezarsen) outperforms expectations, achieved 2025 preliminary U.S. net product sales of $105M* as first FDA-approved treatment for FCS; sNDA
About this update from Ionis Pharmaceuticals, Inc.
[{"type":"text","content":"\n– TRYNGOLZA® (olezarsen) outperforms expectations, achieved 2025 preliminary U.S. net product sales of $105M* as first FDA-approved treatment for FCS; sNDA for sHTG submitted for review –\n\n\n– Increasing annual TRYNGOLZA peak net sales guidance to >$2B for sHTG –\n\n\n– Positive topline results announced for pivotal Phase 3 program of bepirovirsen in chronic hepatitis B; first of five Phase 3 readouts from partnered programs expected this year –\n\n\n CARLSBAD, Calif.--(BUSINESS WIRE)--\nIonis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced highlights from the Company's 2025 achievements and provided additional updates on key milestones expected in 2026. Ionis will provide a business update at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13 at 8:15am PT; the presentation is available today on the Ionis website here.\n\n\n“2025 was a defining year for Ionis, as we successfully executed our first two independent launches as a commercial stage biotech company. We expect 2026 to be another transformative year, poised for two additional independent launches of breakthrough therapies – olezarsen for severe hypertriglyceridemia, Ionis’ first launch in a large patient population, and zilganersen for Alexander disease, Ionis’ first independent launch from our leading neurology pipeline,” said Brett P. Monia, Ph.D., chief executive officer, Ionis. “This momentum is further bolstered by the promise of our late-stage Ionis owned and partnered programs, with a total of five Phase 3 readouts and four NDA submissions anticipated this year. With strong execution and multiple key catalysts expected, Ionis is well-positioned to deliver accelerating revenue growth to achieve cash flow breakeven in 2028.”\n\n\nPreliminary TRYNGOLZA® (olezarsen) 2025 Full Year U.S. Net Sales\n\n\n\nTRYNGOLZA outperformed expectations as the first U.S. Food and Drug Administration (FDA)-approved treatment for familial chylomicronemia syndrome (FCS), generating $105* million in preliminary U.S. net product sales in 2025\n\n\n\n2026 Anticipated Highlights Include:\n\n\nIonis Owned Programs\n\n\n\nPotential approval and launch of olezarsen as the new standard of care for severe hypertriglyceridemia (sHTG)\n\n\nSubmitted U.S. Supplemental New Drug Application (sNDA), following receipt of Breakthrough Therapy Designation\n\n\nOlezarsen ac...