Novartis AGNovartis's key Lp(a)-lowering drug pelacarsen failed its final-stage trial, dashing a potential $3-6B peak-sales opportunity.
Shares of Swiss pharmaceutical giant Novartis fell as much as 3.3% on Monday (Sept. 7) after its key drug designed to lower Lp(a) levels in the blood failed a final-stage trial. The failure casts doubt on this treatment approach and has led investors to turn their attention to and raise expectations for upcoming data from an RNA therapy trial. Late Friday (Sept. 4), Novartis announced that pelacarsen did not significantly reduce the risk of heart attacks and strokes in a large final-stage trial involving patients with high Lp(a) levels, a genetic risk factor for which there is no targeted treatment. Previously, analysts had forecast that if the drug succeeded, it could achieve peak annual sales of $3 billion to $6 billion. The failure also poses a greater challenge to rival drugmakers Amgen and Eli Lilly, which are also in final-stage trials of Lp(a)-lowering drugs. The situation also adds pressure to other drugs in the pipeline, particularly del-desiran, an experimental treatment for myotonic dystrophy type 1 (DM1), with trial results expected in the fourth quarter of this year. Analysts note that the muscular dystrophy drug needs to succeed in trials to justify the investment of up to $12 billion that Novartis spent to acquire the rights to this drug. However, Novartis is also scheduled to report results from a trial of remibrutinib, an anti-inflammatory drug for chronic hidradenitis suppurativa, later this year. This drug recently succeeded in a trial for multiple sclerosis patients, which may help support and cushion investor disappointment. Before the share price decline on Monday, Novartis shares had risen about a fifth since the start of the year, driven by market confidence in its new drug pipeline, despite the company facing pressure from patent expirations on older drugs.
Novartis AGNovartis's key Lp(a)-lowering drug pelacarsen failed its final-stage trial, dashing a potential $3-6B peak-sales opportunity.
Amgen IncNovartis's Lp(a) drug failure casts doubt on the treatment approach and poses a greater challenge to Amgen, which is also in final-stage trials of an Lp(a)-lowering drug.
Eli Lilly and CompanyThe pelacarsen failure casts doubt on the Lp(a)-lowering approach and poses a greater challenge to Eli Lilly, also in final-stage trials of such a drug.