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Novartis' Cosentyx Misses Primary Goal in Arteritis Phase III Study
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Key Takeaways
NVS reported that Cosentyx missed the primary endpoint in a phase III study for giant cell arteritis.
Cosentyx plus a 26-week steroid taper showed no significant remission benefit over placebo and 52-week taper.
While endpoints were missed, Cosentyx showed lower steroid exposure and consistent safety in the GCA study.
Novartis (NVS - Free Report) announced that a late-stage study of its interleukin-17A inhibitor, Cosentyx (secukinumab), has failed to meet the primary endpoint of sustained remission at week 52 for a new indication to treat adult patients with newly diagnosed or relapsing giant cell arteritis (GCA).
Cosentyx, developed by Novartis, was first approved in 2015 for treating adults with psoriatic arthritis (PsA). Since then, its label has been expanded to include several indications, including moderate to severe plaque psoriasis (PsO), ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa (HS), as well as pediatric forms of PsO, enthesitis-related arthritis and juvenile PsA.
NVS’ Phase III Cosentyx Study Result in Detail
Per the data readout from Novartis’ phase III GCAptAIN study, Cosentyx in combination with a 26-week steroid taper did not achieve a statistically significant improvement in sustained remission at week 52 compared to placebo combined with a 52-week taper. Treatment with the combo therapy also failed to meet the study’s secondary endpoints with statistical significance.
Year to date, NVS shares have rallied 27.2% against the industry’s 0.7% decline.
Image Source: Zacks Investment Research
The GCAptAIN study evaluated the efficacy and safety of Cosentyx in patients with GCA. The enrolled patient population was randomized to one of three treatment groups — Cosentyx 300 mg, Cosentyx 150 mg or a placebo, each administered alongside a glucocorticoid (steroid) tapering regimen. Tapering means reducing the steroid exposure to patients over a period of time.
Despite the disappointing results, Cosentyx demonstrated numerically favorable outcomes over placebo in terms of cumulative steroid exposure and steroid-related toxicity. Additionally, the drug’s safety profile in GCA treatment aligned with its established safety record.
As its next steps, Novartis plans on further analyzing the full spectrum of the phase III GCAptAIN study data and sharing results in the future.
GCA, the most prevalent type of systemic vasculitis in individuals over 50, is a medical emergency due to its risk of permanent vision loss and life-threatening aortic aneurysms. In addition to its physical dangers, GCA also severely impacts quality of life, leading to fatigue, cognitive issues, and loss of independence.
Cosentyx is a significant contributor to Novartis’ topline. In the first quarter of 2025, the drug’s sales increased 18% to $1.53 billion, driven by recent launches, including the HS indication and the intravenous formulation in the United States, along with volume growth in core indications. Potential label expansion of Cosentyx in additional indications (cell arteritis and polymyalgia rheumatica) should drive additional growth.
In the past 90 days, loss per share estimates for Immunocore’s 2025 have improved from $1.44 to 70 cents. Loss per share estimates for 2026 have narrowed from $1.45 to $1.08 during the same period. IMCR stock has gained 11% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.
In the past 90 days, Verona Pharma’s bottom-line estimates for 2025 have significantly improved from a loss of 7 cents per share to earnings of 22 cents. During the same timeframe, estimates for 2026 earnings per share have improved from $2.21 to $2.88. VRNA stock has soared 94% so far this year.
Verona Pharma’s earnings beat estimates in one of the trailing four quarters and missed the mark on the other three occasions, delivering an average negative surprise of 6.76%.
BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.27 for 2025 over the past 90 days, while that for 2026 has gone up from $1.28 to $1.34 over the same timeframe. Year to date, shares of Bayer have surged 59.4%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
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Novartis' Cosentyx Misses Primary Goal in Arteritis Phase III Study
Key Takeaways
Novartis (NVS - Free Report) announced that a late-stage study of its interleukin-17A inhibitor, Cosentyx (secukinumab), has failed to meet the primary endpoint of sustained remission at week 52 for a new indication to treat adult patients with newly diagnosed or relapsing giant cell arteritis (GCA).
Cosentyx, developed by Novartis, was first approved in 2015 for treating adults with psoriatic arthritis (PsA). Since then, its label has been expanded to include several indications, including moderate to severe plaque psoriasis (PsO), ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa (HS), as well as pediatric forms of PsO, enthesitis-related arthritis and juvenile PsA.
NVS’ Phase III Cosentyx Study Result in Detail
Per the data readout from Novartis’ phase III GCAptAIN study, Cosentyx in combination with a 26-week steroid taper did not achieve a statistically significant improvement in sustained remission at week 52 compared to placebo combined with a 52-week taper. Treatment with the combo therapy also failed to meet the study’s secondary endpoints with statistical significance.
Year to date, NVS shares have rallied 27.2% against the industry’s 0.7% decline.
Image Source: Zacks Investment Research
The GCAptAIN study evaluated the efficacy and safety of Cosentyx in patients with GCA. The enrolled patient population was randomized to one of three treatment groups — Cosentyx 300 mg, Cosentyx 150 mg or a placebo, each administered alongside a glucocorticoid (steroid) tapering regimen. Tapering means reducing the steroid exposure to patients over a period of time.
Despite the disappointing results, Cosentyx demonstrated numerically favorable outcomes over placebo in terms of cumulative steroid exposure and steroid-related toxicity. Additionally, the drug’s safety profile in GCA treatment aligned with its established safety record.
As its next steps, Novartis plans on further analyzing the full spectrum of the phase III GCAptAIN study data and sharing results in the future.
GCA, the most prevalent type of systemic vasculitis in individuals over 50, is a medical emergency due to its risk of permanent vision loss and life-threatening aortic aneurysms. In addition to its physical dangers, GCA also severely impacts quality of life, leading to fatigue, cognitive issues, and loss of independence.
Cosentyx is a significant contributor to Novartis’ topline. In the first quarter of 2025, the drug’s sales increased 18% to $1.53 billion, driven by recent launches, including the HS indication and the intravenous formulation in the United States, along with volume growth in core indications. Potential label expansion of Cosentyx in additional indications (cell arteritis and polymyalgia rheumatica) should drive additional growth.
Novartis AG Price and Consensus
Novartis AG price-consensus-chart | Novartis AG Quote
NVS’ Zacks Rank & Other Stocks to Consider
Novartis currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) , Verona Pharma (VRNA - Free Report) and Bayer (BAYRY - Free Report) . While IMCR and VRNA sport a Zacks Rank #1 (Strong Buy) each, BAYRY carries a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, loss per share estimates for Immunocore’s 2025 have improved from $1.44 to 70 cents. Loss per share estimates for 2026 have narrowed from $1.45 to $1.08 during the same period. IMCR stock has gained 11% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.
In the past 90 days, Verona Pharma’s bottom-line estimates for 2025 have significantly improved from a loss of 7 cents per share to earnings of 22 cents. During the same timeframe, estimates for 2026 earnings per share have improved from $2.21 to $2.88. VRNA stock has soared 94% so far this year.
Verona Pharma’s earnings beat estimates in one of the trailing four quarters and missed the mark on the other three occasions, delivering an average negative surprise of 6.76%.
BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.27 for 2025 over the past 90 days, while that for 2026 has gone up from $1.28 to $1.34 over the same timeframe. Year to date, shares of Bayer have surged 59.4%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.