Shares of Amgen AMGN were down 5% in after-hours trading on Friday after Novartis NVS announced that the phase III Lp(a)HORIZON study evaluating the latter’s investigational drug pelacarsen in patients with elevated lipoprotein (a) Lp(a) and established cardiovascular disease (CVD) did not meet its primary endpoint.
Year to date, shares of Amgen have rallied 36.3% compared with the industry’s rise of 11.1%.
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What Did NVS Study Show?
The double-blind, placebo-controlled phase III Lp(a)HORIZON study is a cardiovascular outcomes study that assessed whether pelacarsen can reduce the incidence of four-point major adverse cardiovascular events (MACE) in 8,323 patients with elevated lipoprotein(a) [Lp(a)] levels and established cardiovascular disease.
Per Novartis, the study failed to meet its primary endpoint of reducing the risk of cardiovascular events compared with placebo in patients with elevated Lp(a) and established cardiovascular disease.
Treatment with pelacarsen substantially lowered Lp(a) levels, consistent with previous studies. However, this reduction did not translate into a lower risk of cardiovascular events in the overall study population. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and urgent coronary revascularization requiring hospitalization.
Novartis secured global rights from Ionis Pharmaceuticals IONS to develop, manufacture and commercialize pelacarsen under a licensing and collaboration agreement.
Shares of Novartis and Ionis declined following the announcement of the news on Friday.
AMGN Stock Falls
The above study results are particularly relevant to Amgen because the company is developing olpasiran, an investigational siRNA therapy designed to reduce Lp(a) synthesis in the liver. Olpasiran is currently being evaluated in the phase III OCEAN(a)-Outcomes study in patients with established atherosclerotic cardiovascular disease and elevated Lp(a).
It can be inferred that the setback faced by Novartis raises the risk profile around the broader Lp(a)-lowering field, including Amgen's Lp(a) program. The key concern is whether lowering Lp(a) can ultimately translate into fewer cardiovascular events. It remains to be seen how olpasiran performs in late-stage studies, as its phase III outcomes data are still pending.
Though Amgen's olpasiran is a different modality from pelacarsen, investors appear to remain cautious about the potential commercial opportunity for olpasiran until its cardiovascular outcomes data become available.
Per Amgen, if successfully developed, olpasiran has the potential to address an area of significant unmet medical need.
Amgen Inc. Price
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AMGN Zacks Rank
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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This article originally published on Zacks Investment Research (zacks.com).