Pelacarsen

January 12, 2026 — Ionis Pharmaceuticals (NASDAQ: IONS) (via Business Wire/Benzinga) highlighted 2025 achievements and outlined 2026 catalysts, including two planned independent launches and multiple late-stage readouts/filings.

Ionis reported TRYNGOLZA (olezarsen), the first FDA-approved treatment for familial chylomicronemia syndrome (FCS), generated $105M in preliminary unaudited 2025 U.S. net product sales. For a broader indication, Ionis submitted an sNDA for olezarsen in severe hypertriglyceridemia (sHTG) (after Breakthrough Therapy Designation). In Phase 3 CORE/CORE2, olezarsen showed up to 72% placebo-adjusted fasting triglyceride reduction and 85% reduction in acute pancreatitis events, with favorable safety/tolerability; Ionis raised peak annual net sales guidance for sHTG to >$2B (from >$1B).

The company cited early momentum for DAWNZERA (donidalorsen) in hereditary angioedema and expects EMA approval/launch in Q1 2026. Ionis plans an NDA in Q1 2026 for zilganersen (Alexander disease) with a launch later in 2026.

Partnered milestones include planned 2026 regulatory submissions for bepirovirsen (chronic hepatitis B; GSK) after positive Phase 3 topline functional cure results, plus Phase 3 readouts for pelacarsen (Novartis; H1 2026) and eplontersen (AstraZeneca; H2 2026). Ionis reiterated a goal to reach cash-flow breakeven in 2028.