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FDA Approves NVS' Cosentyx in Hidradenitis Suppurativa for Adolescents
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Key Takeaways
Novartis wins FDA nod to expand Cosentyx for patients 12 with moderate to severe hidradenitis suppurativa.
Novartis says Cosentyx is the only IL-17A inhibitor for this adolescent HS population.
Cosentyx generated $6.7B in 2025 sales, up 8% year over year, remaining one of Novartis' top drugs.
Novartis (NVS - Free Report) announced that the FDA approved a label expansion of psoriasis drug Cosentyx.
The regulatory body approved the drug for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population.
The approval makes Cosentyx the only IL-17A inhibitor currently available for this patient population and expands treatment options for adolescents living with the chronic inflammatory skin disease.
Shares of Novartis have gained 36.7% over the past year compared with the industry’s growth of 10%.
Image Source: Zacks Investment Research
More on NVS’ Cosentyx
The approval for patients aged 12 and older weighing at least 30 kg is supported by adult HS studies, pharmacokinetic modeling from adult HS and psoriasis trials, and pediatric clinical data from other approved indications, suggesting comparable drug exposure between pediatric and adult HS patients.
Cosentyx is a fully human monoclonal antibody that blocks interleukin-17A, a cytokine involved in inflammatory pathways underlying several immune-mediated diseases.
The drug is already approved for conditions including HS, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis, as well as several pediatric inflammatory disorders.
The latest approval marks the fourth pediatric indication for Cosentyx, reinforcing its robust safety and efficacy profile.
Cosentyx is one of the top drugs for NVS. The drug generated sales of $6.7 billion in 2025, up 8% from 2024, driven by continued demand from recent launches (including the HS indication and the IV formulation in the US) and volume growth in core indications (psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis).
The drug is also being evaluated for polymyalgia rheumatica.
However, Cosentyx will lose exclusivity in the United States in 2029.
NVS Navigates Generic Competition for Entresto
2026 is a pivotal year for Novartis as it navigates the largest patent expiry in its history for the cardiovascular drug Entresto. Last month, Novartis reported mixed results for the fourth quarter of 2025, with earnings beating estimates but revenues missing the same.
Sales are being adversely impacted by generic competition for key drugs, Entresto (United States) and Promacta.
Novartis is now banking on key growth drivers — Kisqali, Kesimpta, Pluvicto and Scemblix — to support top-line growth.
Pipeline progress remains a major upside, with multiple potential multi-blockbusters advancing through FDA approvals and positive phase III data across Rhapsido, Pluvicto, Itvisma and ianalumab.
The company recently acquired Avidity Biosciences, Inc., adding the latter’s differentiated muscle-targeting antibody oligonucleotide conjugate (AOC) platform and three late-stage programs, further strengthening its industry-leading neuromuscular pipeline.
The transaction could unlock multi-billion-dollar market opportunities, with potential product launches targeted before 2030.
It also enhances Novartis’ late-stage pipeline, supporting the company’s projected 2025-2030 net sales CAGR of 5-6% at constant currency and reinforcing its mid- to long-term growth outlook.
NVS’ Zacks Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for ADMA’s 2026 EPS have increased from 82 cents to 96 cents. ADMA’s shares have lost 18.9% in the past year.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.11 to $1.06. CSTL shares have risen 27.6% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $8.14 to $8.72 for 2026. Over the past year, shares of ANIP have surged 9.16%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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Image: Bigstock
FDA Approves NVS' Cosentyx in Hidradenitis Suppurativa for Adolescents
Key Takeaways
Novartis (NVS - Free Report) announced that the FDA approved a label expansion of psoriasis drug Cosentyx.
The regulatory body approved the drug for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population.
The approval makes Cosentyx the only IL-17A inhibitor currently available for this patient population and expands treatment options for adolescents living with the chronic inflammatory skin disease.
Shares of Novartis have gained 36.7% over the past year compared with the industry’s growth of 10%.
Image Source: Zacks Investment Research
More on NVS’ Cosentyx
The approval for patients aged 12 and older weighing at least 30 kg is supported by adult HS studies, pharmacokinetic modeling from adult HS and psoriasis trials, and pediatric clinical data from other approved indications, suggesting comparable drug exposure between pediatric and adult HS patients.
Cosentyx is a fully human monoclonal antibody that blocks interleukin-17A, a cytokine involved in inflammatory pathways underlying several immune-mediated diseases.
The drug is already approved for conditions including HS, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis, as well as several pediatric inflammatory disorders.
The latest approval marks the fourth pediatric indication for Cosentyx, reinforcing its robust safety and efficacy profile.
Cosentyx is one of the top drugs for NVS. The drug generated sales of $6.7 billion in 2025, up 8% from 2024, driven by continued demand from recent launches (including the HS indication and the IV formulation in the US) and volume growth in core indications (psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis).
The drug is also being evaluated for polymyalgia rheumatica.
However, Cosentyx will lose exclusivity in the United States in 2029.
NVS Navigates Generic Competition for Entresto
2026 is a pivotal year for Novartis as it navigates the largest patent expiry in its history for the cardiovascular drug Entresto.
Last month, Novartis reported mixed results for the fourth quarter of 2025, with earnings beating estimates but revenues missing the same.
Sales are being adversely impacted by generic competition for key drugs, Entresto (United States) and Promacta.
Novartis is now banking on key growth drivers — Kisqali, Kesimpta, Pluvicto and Scemblix — to support top-line growth.
Pipeline progress remains a major upside, with multiple potential multi-blockbusters advancing through FDA approvals and positive phase III data across Rhapsido, Pluvicto, Itvisma and ianalumab.
The company recently acquired Avidity Biosciences, Inc., adding the latter’s differentiated muscle-targeting antibody oligonucleotide conjugate (AOC) platform and three late-stage programs, further strengthening its industry-leading neuromuscular pipeline.
The transaction could unlock multi-billion-dollar market opportunities, with potential product launches targeted before 2030.
It also enhances Novartis’ late-stage pipeline, supporting the company’s projected 2025-2030 net sales CAGR of 5-6% at constant currency and reinforcing its mid- to long-term growth outlook.
NVS’ Zacks Rank and Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the pharma/biotech sector are ADMA Biologics (ADMA - Free Report) , Castle Biosciences (CSTL - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While ADMA and CSTL currently sport a Zacks Rank #1 (Strong Buy) each, ANIP carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for ADMA’s 2026 EPS have increased from 82 cents to 96 cents. ADMA’s shares have lost 18.9% in the past year.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.11 to $1.06. CSTL shares have risen 27.6% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $8.14 to $8.72 for 2026. Over the past year, shares of ANIP have surged 9.16%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.