We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
AstraZeneca's (AZN) Fasenra Gets FDA Nod for Asthma in Kids
Read MoreHide Full Article
AstraZeneca (AZN - Free Report) announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab), for use in children. The regulatory body has now approved Fasenra as an add-on maintenance treatment for severe asthma in patients aged six to 11 years with an eosinophilic phenotype.
Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in patients aged 12 and older.
The latest approval for Fasenra was based on data from the open-label phase III TATE study, as well as other studies in adult and adolescent patient populations.
Data from the TATE study showed that treatment with Fasenra demonstrated pharmacokinetics and pharmacodynamics in children aged six to 11 years old with SEA, thereby meeting the primary endpoints of the study.
Importantly, the recommended dose for Fasenra is 30 mg for children aged six years and older weighing 35 kg or more. However, for children who weigh less than 35 kg in the same age group, a new 10 mg dose of Fasenra will now be available.
Shares of AstraZeneca have increased 3.1% so far this year compared with the industry’s 10.8% rise.
Image Source: Zacks Investment Research
Fasenra is currently approved in more than 80 countries across the world including the United States, European Union and Japan for SEA. Several label expansion studies are going on for Fasenra for eosinophil-driven diseases beyond severe asthma like chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.
Fasenra generated sales worth $1.6 billion in 2023, reflecting an increase of 12% year over year at a constant exchange rate.
Successful label expansion for Fasenra into additional indications and patient populations should boost drug sales in the days ahead.
In a separate press release, AstraZeneca announced a 7% or a 20 cents hike in its annualized dividend taking it to $3.10 per share from $2.90 for 2024. The company has been regularly paying half-yearly interim dividends.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Year to date, shares of ADMA have rallied 37.6%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have gained 14%.
Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. Year to date, shares of ANIP have jumped 23.5%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
AstraZeneca's (AZN) Fasenra Gets FDA Nod for Asthma in Kids
AstraZeneca (AZN - Free Report) announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab), for use in children. The regulatory body has now approved Fasenra as an add-on maintenance treatment for severe asthma in patients aged six to 11 years with an eosinophilic phenotype.
Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in patients aged 12 and older.
The latest approval for Fasenra was based on data from the open-label phase III TATE study, as well as other studies in adult and adolescent patient populations.
Data from the TATE study showed that treatment with Fasenra demonstrated pharmacokinetics and pharmacodynamics in children aged six to 11 years old with SEA, thereby meeting the primary endpoints of the study.
Importantly, the recommended dose for Fasenra is 30 mg for children aged six years and older weighing 35 kg or more. However, for children who weigh less than 35 kg in the same age group, a new 10 mg dose of Fasenra will now be available.
Shares of AstraZeneca have increased 3.1% so far this year compared with the industry’s 10.8% rise.
Image Source: Zacks Investment Research
Fasenra is currently approved in more than 80 countries across the world including the United States, European Union and Japan for SEA. Several label expansion studies are going on for Fasenra for eosinophil-driven diseases beyond severe asthma like chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.
Fasenra generated sales worth $1.6 billion in 2023, reflecting an increase of 12% year over year at a constant exchange rate.
Successful label expansion for Fasenra into additional indications and patient populations should boost drug sales in the days ahead.
In a separate press release, AstraZeneca announced a 7% or a 20 cents hike in its annualized dividend taking it to $3.10 per share from $2.90 for 2024. The company has been regularly paying half-yearly interim dividends.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Year to date, shares of ADMA have rallied 37.6%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have gained 14%.
Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.43. Year to date, shares of ANIP have jumped 23.5%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.