Particle.news
Download on the App Store

NovartisPelacarsen Fails Phase 3 Outcome Trial

The drug sharply cut the genetic risk marker Lp(a) but did not lower heart attacks, strokes or cardiovascular deaths, raising new questions about the strategy and leaving rivals’ trials as the next test.

Overview

  • Novartis confirmed on September 4 that pelacarsen met its goal of substantially lowering Lp(a) but did not reduce the trial’s composite of cardiovascular death, heart attack, stroke, or urgent coronary revascularization.
  • The negative topline result sent Novartis and development partner Ionis shares sharply lower and prompted investors to downgrade the odds for other Lp(a) programs.
  • Investors applied a negative read‑through to Amgen’s olpasiran and briefly knocked down Amgen’s market value even though olpasiran’s Phase 3 OCEAN(a)-Outcomes results are not yet public.
  • Analysts say interpretation will hinge on full pelacarsen data expected at a forthcoming medical meeting, which must show subgroup results, the absolute degree of Lp(a) lowering, and trial design details to tell whether this is a class failure or a trial‑specific outcome.
  • The pelacarsen setback changes the risk profile for rival programs such as Amgen’s olpasiran and Eli Lilly’s lepodisiran and could alter near‑term investment, licensing and development plans while regulators and clinicians await more complete data.