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Novartis Late-Stage Cardiovascular Outcome Study Fails, Stock Down
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Key Takeaways
Novartis' phase III pelacarsen study fails to reduce major cardiovascular events versus placebo.
Pelacarsen lowered Lp(a) levels, but the study missed its primary endpoint in 8,323 patients.
Novartis faces generic pressure as it works to grow newer brands and strengthen its drug portfolio.
Novartis (NVS - Free Report) announced that the late-stage study on investigational candidate, pelacarsen, failed.
Pelacarsen is an investigational antisense oligonucleotide (ASO) designed to potently inhibit lipoprotein (a), Lp(a), production at its source.
Novartis secured global rights from Ionis Pharmaceuticals (IONS - Free Report) to develop, manufacture and commercialize pelacarsen under a licensing and collaboration agreement.
Shares of Novartis lost 4.7% in after-hours trading following the results while IONS was down 10%.
Year to date, Novartis shares have gained 16.1% compared with the industry’s growth of 14.5%.
Image Source: Zacks Investment Research
More on NVS’ Late-Stage CVD Study
Lp(a)HORIZON is a phase III, randomized, placebo-controlled, double-blind, parallel-group, multi-center global cardiovascular outcomes trial evaluating whether pelacarsen can reduce the incidence of four-point major adverse cardiovascular events in 8,323 patients with elevated lipoprotein(a) [Lp(a)] levels and established cardiovascular disease.
However, the study did not meet the primary endpoint of reducing the risk of cardiovascular events, a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and urgent coronary revascularization requiring hospitalization, as compared to placebo.
Elevated Lp(a) is an inherited cardiovascular risk factor that affects approximately one in five people worldwide, with no approved targeted therapies currently available.
Nonetheless, lower lipoprotein (a), Lp(a), levels were achieved with pelacarsen in this study population, which was receiving guideline-directed treatments, including lipid lowering and antihypertensive therapies.
The failure of this late-stage study is a setback for NVS as the company is looking to develop new drugs in wake of generic competition for some of its blockbuster drugs.
Moreover, the targeted market has huge potential and the successful development of pelacarsen would have been a significant boost for the company.
Ionis Pharmaceuticals discovered pelacarsen and led its early development. In February 2019, Novartis exercised its option to license the rights to develop and commercialize pelacarsen as a targeted cardiovascular therapy.
Meanwhile, sales of biotech giant Amgen (AMGN - Free Report) too declined 5% in after-hours trading on Sept. 4 following NVS’ announcement.
Investors were probably wary as AMGN is developing olpasiran, best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver, in late-stage studies.
The failure of NVS’ study on pelacarsen clouds the prospects of AMGN’s olpasiran as well.
NVS’ cardiovascular portfolio comprises blockbuster drug Entresto.
However, generic competition, including the loss of U.S. exclusivity, has adversely impacted Entresto sales of late.
Despite a massive decline in Entresto sales, Novartis delivered a strong second-quarter performance, demonstrating that its portfolio of newer growth products is increasingly capable of offsetting the impact of generic competition for Entresto. Oncology drug Promacta is also facing generic competition.
Strong demand for key growth brands, including Kisqali, Kesimpta, Scemblix, Pluvicto and Leqvio, is boosting the top line.
With 2026 marking the largest patent cliff in the company's history, execution remains the key investment theme.
Last week, NVS announced positive top-line results from the late-stage REMODEL-1/-2 studies on remibrutinib in relapsing multiple sclerosis.
Remibrutinib is a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK pathway, reducing the activation of B cells and innate immune cells to modulate immune regulatory networks and associated neuroinflammation.
The studies met their primary endpoint, significantly reducing annualized relapse rate versus Aubagio in the targeted patient population.
Remibrutinib 25 mg is already approved as Rhapsido by the FDA in September 2025 and the EMA in April 2026 for the treatment of adults with CSU.
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Novartis Late-Stage Cardiovascular Outcome Study Fails, Stock Down
Key Takeaways
Novartis (NVS - Free Report) announced that the late-stage study on investigational candidate, pelacarsen, failed.
Pelacarsen is an investigational antisense oligonucleotide (ASO) designed to potently inhibit lipoprotein (a), Lp(a), production at its source.
Novartis secured global rights from Ionis Pharmaceuticals (IONS - Free Report) to develop, manufacture and commercialize pelacarsen under a licensing and collaboration agreement.
Shares of Novartis lost 4.7% in after-hours trading following the results while IONS was down 10%.
Year to date, Novartis shares have gained 16.1% compared with the industry’s growth of 14.5%.
Image Source: Zacks Investment Research
More on NVS’ Late-Stage CVD Study
Lp(a)HORIZON is a phase III, randomized, placebo-controlled, double-blind, parallel-group, multi-center global cardiovascular outcomes trial evaluating whether pelacarsen can reduce the incidence of four-point major adverse cardiovascular events in 8,323 patients with elevated lipoprotein(a) [Lp(a)] levels and established cardiovascular disease.
However, the study did not meet the primary endpoint of reducing the risk of cardiovascular events, a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and urgent coronary revascularization requiring hospitalization, as compared to placebo.
Elevated Lp(a) is an inherited cardiovascular risk factor that affects approximately one in five people worldwide, with no approved targeted therapies currently available.
Nonetheless, lower lipoprotein (a), Lp(a), levels were achieved with pelacarsen in this study population, which was receiving guideline-directed treatments, including lipid lowering and antihypertensive therapies.
The failure of this late-stage study is a setback for NVS as the company is looking to develop new drugs in wake of generic competition for some of its blockbuster drugs.
Moreover, the targeted market has huge potential and the successful development of pelacarsen would have been a significant boost for the company.
Ionis Pharmaceuticals discovered pelacarsen and led its early development. In February 2019, Novartis exercised its option to license the rights to develop and commercialize pelacarsen as a targeted cardiovascular therapy.
Meanwhile, sales of biotech giant Amgen (AMGN - Free Report) too declined 5% in after-hours trading on Sept. 4 following NVS’ announcement.
Investors were probably wary as AMGN is developing olpasiran, best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver, in late-stage studies.
The failure of NVS’ study on pelacarsen clouds the prospects of AMGN’s olpasiran as well.
Novartis AG Price, Consensus and EPS Surprise
Novartis AG price-consensus-eps-surprise-chart | Novartis AG Quote
Novartis Looks to Strengthen Portfolio
NVS’ cardiovascular portfolio comprises blockbuster drug Entresto.
However, generic competition, including the loss of U.S. exclusivity, has adversely impacted Entresto sales of late.
Despite a massive decline in Entresto sales, Novartis delivered a strong second-quarter performance, demonstrating that its portfolio of newer growth products is increasingly capable of offsetting the impact of generic competition for Entresto.
Oncology drug Promacta is also facing generic competition.
Strong demand for key growth brands, including Kisqali, Kesimpta, Scemblix, Pluvicto and Leqvio, is boosting the top line.
With 2026 marking the largest patent cliff in the company's history, execution remains the key investment theme.
Last week, NVS announced positive top-line results from the late-stage REMODEL-1/-2 studies on remibrutinib in relapsing multiple sclerosis.
Remibrutinib is a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK pathway, reducing the activation of B cells and innate immune cells to modulate immune regulatory networks and associated neuroinflammation.
The studies met their primary endpoint, significantly reducing annualized relapse rate versus Aubagio in the targeted patient population.
Remibrutinib 25 mg is already approved as Rhapsido by the FDA in September 2025 and the EMA in April 2026 for the treatment of adults with CSU.
NVS’ Zacks Rank
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.