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NVS Gets Positive CHMP Opinion for Cosentyx for Another Indication
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Key Takeaways
Novartis' Cosentyx gains a positive CHMP opinion for adults with PMR after inadequate steroid response.
The REPLENISH study met all primary and secondary endpoints for both Cosentyx doses through week 52.
Cosentyx sales rose 7% in the United States, while Europe and most emerging markets also grew.
Novartis (NVS - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has issued a positive opinion recommending marketing authorization for an additional indication of its arthritis drug Cosentyx (secukinumab).
The CHMP recommended Cosentyx for the treatment of polymyalgia rheumatica (PMR) in adults who have an inadequate response to steroids or experience a relapse while tapering steroid treatment.
Cosentyx is a fully human biologic that selectively targets and inhibits interleukin-17A. The drug is already approved for several inflammatory conditions in adults, including psoriatic arthritis (PsA), moderate-to-severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis and hidradenitis suppurativa (HS).
Cosentyx also has pediatric indications, including PsO, juvenile psoriatic arthritis and enthesitis-related arthritis. In the United States, it is additionally approved for pediatric patients aged 12 years and older with moderate-to-severe HS and juvenile AS.
More on CHMP Positive Opinion for NVS’ Cosentyx for PMR
The positive CHMP opinion is supported by results from the late-stage REPLENISH study, wherein patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen. The study met all primary and secondary endpoints across both Cosentyx 300mg and 150mg treatment arms, including complete sustained remission and time until patients needed additional treatment through week 52.
Following the CHMP recommendation for approval, the European Commission is expected to issue a final decision within approximately two months.
If approved, Cosentyx will be the first interleukin-17A inhibitor approved in Europe for adults with PMR, providing new treatment option after steroids.
PMR is a common inflammatory rheumatic disease affecting adults aged 50 years and older, typically characterized by acute pain and stiffness in the shoulders, neck and hips.
Cosentyx sales totaled $3.4 billion in the United States, up 7%, driven by strong U.S. performance, including growth in HS and IV. Ex-U.S. sales grew in Europe and most emerging markets, partly offset by a decline in China.
Recent Updates From NVS
2026 marks the largest patent cliff in the company's history. NVS is looking to strengthen its portfolio as generic competition for blockbuster cardiovascular drug Entresto is adversely impacting sales. Oncology drug Promacta is also facing generic competition.
While strong demand for key growth brands, including Kisqali, Kesimpta, Scemblix, Pluvicto and Leqvio, is boosting the top line, NVS’ pipeline needs to deliver.
However, the company has recently suffered back-to-back pipeline setbacks, which have dampened investor sentiment.
Year to date, Novartis shares have gained 1.8% compared with the industry’s growth of 10.7%.
Image Source: Zacks Investment Research
Earlier in the month, Novartis announced that the late-stage study on investigational candidate, pelacarsen, failed.
Novartis secured global rights from Ionis Pharmaceuticals (IONS - Free Report) to develop, manufacture and commercialize pelacarsen under a licensing and collaboration agreement.
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.
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.
The late-stage HARBOR study evaluating del-desiran in people living with myotonic dystrophy type 1 (DM1) also failed to meet the primary endpoint.
Results showed that del-desiran failed to demonstrate a statistically significant improvement over placebo on the primary endpoint of video hand opening time, a novel measure of hand myotonia.
NVS’ Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the drug/biotech sector are Repligen (RGEN - Free Report) and Anika Therapeutics (ANIK - Free Report) . While RGEN sports a Zacks Rank #1 (Strong Buy), ANIK carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share (EPS) have risen from $1.99 to $2.06, while those for 2027 EPS have increased from $2.57 to $2.61 during the same period.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 30 days, estimates for Anika Therapeutics’ 2026 EPS have risen from 53 cents to $1.05, while those for 2027 EPS have increased from 74 cents to 95 cents over the same period. ANIK’s shares have surged 117.3% year to date.
View the Zacks #1 Rank List
Image: Bigstock
NVS Gets Positive CHMP Opinion for Cosentyx for Another Indication
Key Takeaways
Novartis (NVS - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has issued a positive opinion recommending marketing authorization for an additional indication of its arthritis drug Cosentyx (secukinumab).
The CHMP recommended Cosentyx for the treatment of polymyalgia rheumatica (PMR) in adults who have an inadequate response to steroids or experience a relapse while tapering steroid treatment.
Cosentyx is a fully human biologic that selectively targets and inhibits interleukin-17A. The drug is already approved for several inflammatory conditions in adults, including psoriatic arthritis (PsA), moderate-to-severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis and hidradenitis suppurativa (HS).
Cosentyx also has pediatric indications, including PsO, juvenile psoriatic arthritis and enthesitis-related arthritis. In the United States, it is additionally approved for pediatric patients aged 12 years and older with moderate-to-severe HS and juvenile AS.
Novartis AG Price, Consensus and EPS Surprise
Novartis AG price-consensus-eps-surprise-chart | Novartis AG Quote
More on CHMP Positive Opinion for NVS’ Cosentyx for PMR
The positive CHMP opinion is supported by results from the late-stage REPLENISH study, wherein patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen. The study met all primary and secondary endpoints across both Cosentyx 300mg and 150mg treatment arms, including complete sustained remission and time until patients needed additional treatment through week 52.
Following the CHMP recommendation for approval, the European Commission is expected to issue a final decision within approximately two months.
If approved, Cosentyx will be the first interleukin-17A inhibitor approved in Europe for adults with PMR, providing new treatment option after steroids.
PMR is a common inflammatory rheumatic disease affecting adults aged 50 years and older, typically characterized by acute pain and stiffness in the shoulders, neck and hips.
Cosentyx sales totaled $3.4 billion in the United States, up 7%, driven by strong U.S. performance, including growth in HS and IV. Ex-U.S. sales grew in Europe and most emerging markets, partly offset by a decline in China.
Recent Updates From NVS
2026 marks the largest patent cliff in the company's history. NVS is looking to strengthen its portfolio as generic competition for blockbuster cardiovascular drug Entresto is adversely impacting sales. Oncology drug Promacta is also facing generic competition.
While strong demand for key growth brands, including Kisqali, Kesimpta, Scemblix, Pluvicto and Leqvio, is boosting the top line, NVS’ pipeline needs to deliver.
However, the company has recently suffered back-to-back pipeline setbacks, which have dampened investor sentiment.
Year to date, Novartis shares have gained 1.8% compared with the industry’s growth of 10.7%.
Image Source: Zacks Investment Research
Earlier in the month, Novartis announced that the late-stage study on investigational candidate, pelacarsen, failed.
Novartis secured global rights from Ionis Pharmaceuticals (IONS - Free Report) to develop, manufacture and commercialize pelacarsen under a licensing and collaboration agreement.
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.
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.
The late-stage HARBOR study evaluating del-desiran in people living with myotonic dystrophy type 1 (DM1) also failed to meet the primary endpoint.
Results showed that del-desiran failed to demonstrate a statistically significant improvement over placebo on the primary endpoint of video hand opening time, a novel measure of hand myotonia.
NVS’ Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the drug/biotech sector are Repligen (RGEN - Free Report) and Anika Therapeutics (ANIK - Free Report) . While RGEN sports a Zacks Rank #1 (Strong Buy), ANIK carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share (EPS) have risen from $1.99 to $2.06, while those for 2027 EPS have increased from $2.57 to $2.61 during the same period.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 30 days, estimates for Anika Therapeutics’ 2026 EPS have risen from 53 cents to $1.05, while those for 2027 EPS have increased from 74 cents to 95 cents over the same period. ANIK’s shares have surged 117.3% year to date.