Ionis ‘remains confident in pelacarsen’ after Novartis update on Phase 3 timing

Ionis (IONS) partner Novartis (NVS) shared in their year-end earnings report that Phase 3 pelacarsen data is now expected in the first half of 2026 with subsequent regulatory submissions in the second half of next year, Ionis noted. “This update is based on the accrual rate of blinded events in the ongoing Phase 3 Lp(a)HORIZON event-driven cardiovascular outcomes study that Novartis is conducting in more than 8,000 patients. Ionis remains confident in pelacarsen and the Lp(a)HORIZON study and its potential to show benefit in patients with cardiovascular disease and high Lp(a). Pelacarsen, an investigational antisense medicine designed to lower Lp(a), was discovered by Ionis and licensed to Novartis in 2019. It is estimated that more than eight million people worldwide have elevated Lp(a) and cardiovascular disease. The Lp(a)HORIZON trial is expected to be the first cardiovascular outcomes trial to report results on the effect of Lp(a) lowering on cardiovascular risk reduction,” Ionis stated.