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EMA Accepts GSK's Filing for Expanded Use of Nucala in COPD
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GSK plc (GSK - Free Report) announced that the European Medicines Agency (“EMA”) has accepted for review a regulatory filing, seeking approval for a new indication of its respiratory drug, Nucala (mepolizumab). The application seeks approval of Nucala as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (“COPD”) with an eosinophilic phenotype.
Nucala is currently approved in Europe for four IL-5-mediated conditions, severe eosinophilic asthma (in patients aged 6+), chronic rhinosinusitis with nasal polyps in adults, relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (in patients aged 6+) and inadequately controlled hypereosinophilic syndrome in adults.
A similar regulatory filing seeking approval for Nucala as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype is currently under review in the United States. A decision from the FDA is due on May 7, 2025.
GSK’s Nucala is a monoclonal antibody with a novel mechanism of action that targets IL-5, a key messenger protein (cytokine) in type 2 inflammation. Currently, Nucala is not approved for treating COPD anywhere in the world.
Year to date, shares of GSK have gained 16.1% compared with the industry’s rise of 5.7%.
Image Source: Zacks Investment Research
More on GSK's Nucala Filing for COPD
The regulatory application seeking approval of Nucala for treating COPD in Europe was based on positive data from the phase III MATINEE study.
Data from the study showed that the addition of Nucala to inhaled maintenance therapy, led to a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo, thereby meeting the primary endpoint of the MATINEE study.
COPD is a progressive and heterogeneous inflammatory lung disease that encompasses chronic bronchitis and emphysema. It affects more than 40 million people in Europe. The disease ranks as one of the leading causes of hospitalization in many countries globally.
If approved, Nucala would become the first biologic with a monthly dosing option for patients with COPD in Europe.
Nucala generated sales worth £1.78 billion in 2024, increasing 12% year over year at constant exchange rate. The drug remains one of the key top-line drivers for GSK.
In the past 60 days, estimates for Gilead’s earnings per share have increased from $7.56 to $7.87 for 2025. During the same time, earnings per share have increased from $7.76 to $8.27 for 2026. Year to date, shares of GILD have increased 15.9%.
GILD’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.47%.
In the past 60 days, estimates for Dynavax’s earnings per share have increased from 32 cents to 33 cents for 2025. During the same time, earnings per share have increased from 49 cents to 57 cents for 2026. Year to date, shares of DVAX have risen 8.2%.
DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.
In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $6 to $7.06 for 2025. During the same time, earnings per share have increased from $9.15 to $11 for 2026. Year to date, shares of KRYS have rallied 19.5%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.
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EMA Accepts GSK's Filing for Expanded Use of Nucala in COPD
GSK plc (GSK - Free Report) announced that the European Medicines Agency (“EMA”) has accepted for review a regulatory filing, seeking approval for a new indication of its respiratory drug, Nucala (mepolizumab). The application seeks approval of Nucala as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (“COPD”) with an eosinophilic phenotype.
Nucala is currently approved in Europe for four IL-5-mediated conditions, severe eosinophilic asthma (in patients aged 6+), chronic rhinosinusitis with nasal polyps in adults, relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (in patients aged 6+) and inadequately controlled hypereosinophilic syndrome in adults.
A similar regulatory filing seeking approval for Nucala as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype is currently under review in the United States. A decision from the FDA is due on May 7, 2025.
GSK’s Nucala is a monoclonal antibody with a novel mechanism of action that targets IL-5, a key messenger protein (cytokine) in type 2 inflammation. Currently, Nucala is not approved for treating COPD anywhere in the world.
Year to date, shares of GSK have gained 16.1% compared with the industry’s rise of 5.7%.
Image Source: Zacks Investment Research
More on GSK's Nucala Filing for COPD
The regulatory application seeking approval of Nucala for treating COPD in Europe was based on positive data from the phase III MATINEE study.
Data from the study showed that the addition of Nucala to inhaled maintenance therapy, led to a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo, thereby meeting the primary endpoint of the MATINEE study.
COPD is a progressive and heterogeneous inflammatory lung disease that encompasses chronic bronchitis and emphysema. It affects more than 40 million people in Europe. The disease ranks as one of the leading causes of hospitalization in many countries globally.
If approved, Nucala would become the first biologic with a monthly dosing option for patients with COPD in Europe.
Nucala generated sales worth £1.78 billion in 2024, increasing 12% year over year at constant exchange rate. The drug remains one of the key top-line drivers for GSK.
GSK's Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Gilead Sciences, Inc. (GILD - Free Report) , Dynavax Technologies Corporation (DVAX - Free Report) and Krystal Biotech, Inc. (KRYS - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Gilead’s earnings per share have increased from $7.56 to $7.87 for 2025. During the same time, earnings per share have increased from $7.76 to $8.27 for 2026. Year to date, shares of GILD have increased 15.9%.
GILD’s earnings beat estimates in each of the trailing four quarters, the average surprise being 19.47%.
In the past 60 days, estimates for Dynavax’s earnings per share have increased from 32 cents to 33 cents for 2025. During the same time, earnings per share have increased from 49 cents to 57 cents for 2026. Year to date, shares of DVAX have risen 8.2%.
DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.
In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $6 to $7.06 for 2025. During the same time, earnings per share have increased from $9.15 to $11 for 2026. Year to date, shares of KRYS have rallied 19.5%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.