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AstraZeneca's Trixeo Secures Approval for Asthma in the EU
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Key Takeaways
AstraZeneca's Trixeo is approved in the EU for previously treated asthma patients aged 12 and older.
Trixeo is the first and only approved triple-combination therapy for this EU asthma population.
Phase III studies showed improved lung function and fewer severe asthma attacks, with no new safety concerns.
AstraZeneca (AZN - Free Report) announced that the European Commission has approved its respiratory drug, Trixeo Aerosphere, for a new indication.
The drug is approved in the European Union (EU) as a maintenance treatment for previously treated asthma patients aged 12 years and older who are not adequately controlled with inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) therapy.
The regulatory decision was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency had issued a positive opinion recommending the approval in July.
Trixeo is a single-inhaler fixed-dose treatment that combines an ICS, LABA and long-acting muscarinic antagonist. With the latest approval, Trixeo becomes the first and only triple-combination therapy approved for this asthma patient population. It is already approved in the EU for chronic obstructive pulmonary disease (COPD).
Trixeo Aerosphere is marketed as Breztri Aerosphere in the United States and Japan for asthma, while regulatory applications are under review in China and other markets. Trixeo/Breztri is approved for the treatment of COPD globally.
Year to date, AZN shares have lost 7.5% against the industry’s 8% growth.
Image Source: Zacks Investment Research
Trixeo’s EU Approval Backed by AZN's Positive Phase III Data
The European Commission’s approval of Trixeo for asthma was based on positive results from the phase III KALOS and LOGOS studies, which showed that Trixeo significantly improved lung function in patients compared with ICS/LABA treatments. A pooled analysis of the two studies also showed a significant reduction in the annual rate of severe asthma attacks. Notably, the drug showed a rapid effect, improving lung function within five minutes of the first dose. No new safety or tolerability concerns were reported.
Asthma is a chronic respiratory disease affecting millions of people worldwide, including nearly 43 million in Europe and many patients remain uncontrolled despite standard treatments. Uncontrolled asthma can cause airway inflammation and tightening, leading to wheezing, breathlessness, coughing, asthma attacks and reduced quality of life.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have surged 88.8% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 have been unchanged at 17 cents per share. ACIU shares have lost 13.1% year to date.
AC Immune’s earnings beat estimates in the trailing four quarters, the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 73.1% year to date.
Aldeyra Therapeutics’ earnings beat estimates in the trailing four quarters, delivering an average surprise of 29.25%.
View the Zacks #1 Rank List
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AstraZeneca's Trixeo Secures Approval for Asthma in the EU
Key Takeaways
AstraZeneca (AZN - Free Report) announced that the European Commission has approved its respiratory drug, Trixeo Aerosphere, for a new indication.
The drug is approved in the European Union (EU) as a maintenance treatment for previously treated asthma patients aged 12 years and older who are not adequately controlled with inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) therapy.
The regulatory decision was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency had issued a positive opinion recommending the approval in July.
Trixeo is a single-inhaler fixed-dose treatment that combines an ICS, LABA and long-acting muscarinic antagonist. With the latest approval, Trixeo becomes the first and only triple-combination therapy approved for this asthma patient population. It is already approved in the EU for chronic obstructive pulmonary disease (COPD).
Trixeo Aerosphere is marketed as Breztri Aerosphere in the United States and Japan for asthma, while regulatory applications are under review in China and other markets. Trixeo/Breztri is approved for the treatment of COPD globally.
Year to date, AZN shares have lost 7.5% against the industry’s 8% growth.
Image Source: Zacks Investment Research
Trixeo’s EU Approval Backed by AZN's Positive Phase III Data
The European Commission’s approval of Trixeo for asthma was based on positive results from the phase III KALOS and LOGOS studies, which showed that Trixeo significantly improved lung function in patients compared with ICS/LABA treatments. A pooled analysis of the two studies also showed a significant reduction in the annual rate of severe asthma attacks. Notably, the drug showed a rapid effect, improving lung function within five minutes of the first dose. No new safety or tolerability concerns were reported.
Asthma is a chronic respiratory disease affecting millions of people worldwide, including nearly 43 million in Europe and many patients remain uncontrolled despite standard treatments. Uncontrolled asthma can cause airway inflammation and tightening, leading to wheezing, breathlessness, coughing, asthma attacks and reduced quality of life.
AZN’s Zacks Rank & Stocks to Consider
AZN currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have surged 88.8% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 have been unchanged at 17 cents per share. ACIU shares have lost 13.1% year to date.
AC Immune’s earnings beat estimates in the trailing four quarters, the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 73.1% year to date.
Aldeyra Therapeutics’ earnings beat estimates in the trailing four quarters, delivering an average surprise of 29.25%.