Peptide News Digest

#Lp-A-Lipoprotein-A

2 stories

Industry · View digest

Amgen Shares Fall 10% Tuesday to $394 on Lp(a)-Class Fears After Novartis Pelacarsen Phase 3 Miss; Olpasiran Readthrough in Focus

Amgen (NASDAQ: AMGN) shares fell approximately 10% to $394.38 by midday Tuesday September 8, 2026 as investors continued to reprice the entire Lp(a)-lowering cardiovascular hypothesis following Novartis' Friday September 4 announcement that pelacarsen missed the primary MACE endpoint in the Phase 3 Lp(a)HORIZON trial. Amgen's olpasiran (RNAi Lp(a) suppressor) is the most direct readthrough: the Phase 3 OCEAN(a) trial is enrolling patients with elevated Lp(a) and established cardiovascular disease with a similar Lp(a)-lowering-plus-cardiovascular-outcome design and is estimated to read out 2027-2028. Lilly's lepodisiran (RNAi) is running in a broader group including primary-prevention patients, which analyst commentary suggests partly insulates it from the Novartis-specific readthrough. Silence Therapeutics' zerlasiran (RNAi) lowered Lp(a) by up to 85% at 36 weeks in ALPACAR-360; Silence has FDA feedback on a proposed Phase 3 design but is dependent on securing a development partner. The Lp(a) hypothesis question is now whether the drug class lowers hard cardiovascular outcomes, not whether the class lowers Lp(a) levels — that latter question was already answered in the affirmative.

Clinical Trials · View digest

Novartis Pelacarsen Misses Primary Cardiovascular Endpoint in Phase 3 Lp(a)HORIZON Trial Despite Substantial Lp(a) Reduction; Reshapes Lp(a)-Targeting Landscape

Novartis (NYSE: NVS) announced Friday September 4, 2026 that the pelacarsen Phase 3 Lp(a)HORIZON trial did not meet its primary endpoint of reducing major adverse cardiovascular events (a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and urgent coronary revascularization requiring hospitalization) versus placebo in patients with elevated lipoprotein(a) plus established cardiovascular disease on guideline-directed background therapy including lipid-lowering and antihypertensive medications. Pelacarsen (an antisense oligonucleotide targeting hepatic APO(a) production, licensed from Ionis Pharmaceuticals in 2019) did achieve substantial lower Lp(a) levels versus placebo. The trial enrolled roughly 8,000 patients globally over 6 years and represents the largest and most consequential test to date of the Lp(a)-as-causal-cardiovascular-risk-factor hypothesis. The miss substantially raises the bar for Amgen's olpasiran (RNAi, Phase 3 OCEAN(a) ongoing), Silence Therapeutics's zerlasiran (RNAi), and Lilly's lepodisiran (RNAi) — all of which are testing similar Lp(a)-lowering-plus-cardiovascular-outcome frameworks. Ionis and Royalty Pharma both hold economic interests in pelacarsen.