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.
CHMP Endorses AstraZeneca's (AZN) Enhertu in Lung Cancer
Read MoreHide Full Article
AstraZeneca (AZN - Free Report) announced that the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion recommending label expansion for Enhertu (trastuzumab deruxtecan) in non-small cell lung cancer (“NSCLC”).
The CHMP recommends approving Enhertu to treat adult patients with advanced NSCLC whose tumors have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
The positive recommendation is based on data from the phase II DESTINY-Lung02 study, which evaluated Enhertu in patients with previously treated advanced or metastatic HER2-mutant (“HER2m”) NSCLC. Study participants who were treated with Enhertu achieved durable and robust tumor responses. Data from the study demonstrated that patients treated with Enhertu achieved a confirmed objective response rate (“ORR”) of 49.0% and a median duration of response (“mDOR”) of 16.8 months.
Enhertu is approved under the accelerated pathway for a similar indication in the United States, based on data from the DESTINY-Lung02 study.
Apart from the NSCLC indication, Enhertu is approved in the United States and European Union (“EU”) for three indications – two in breast cancer and one in the indication of gastric cancer.
AstraZeneca’s shares have inched up 0.7% year to date compared with the industry’s 8.1% growth.
Image Source: Zacks Investment Research
Currently, no HER2-targeted therapies are approved in the EU for NSCLC indication. A potential approval to Enhertu in NSCLC will provide the first targeted treatment option for this patient group.
A HER2-directed antibody drug conjugate (“ADC”), Enhertu, has been developed by AstraZeneca in collaboration with Daiichi Sankyo. Per an agreement entered in 2019, both companies jointly agreed to develop and commercialize Enhertu globally except in Japan, where Daiichi Sankyo maintains exclusive rights.
In the past 30 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.79 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.04 to $2.77. Year to date, shares of Annovis have lost 21.1%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 30 days, estimates for Precision BioSciences’ 2023 loss per share have improved from 82 cents to 77 cents. During the same period, the loss estimates per share for 2024 have narrowed down from 48 cents to 31 cents. Year to date, shares of DTIL have lost 65.6%.
Earnings of Precision BioSciences beat estimates in two of the trailing four quarters while beating the mark on other two occasions, delivering an average earnings surprise of 20.20%. In the last reported quarter, Precision BioSciences’ earnings beat estimates by 56.52%.
In the past 30 days, estimates for Selecta Biosciences’ 2023 loss per share have improved from 39 cents to 33 cents. During the same period, the estimates per share for 2024 narrowed down from 35 cents to 7 cents. Year to date, shares of Selecta have risen 0.9%.
Earnings of Selecta Biosciences beat estimates in two of the trailing four quarters and missed in the remaining two, the average negative surprise being 47.57%. In the last reported quarter, Selecta Biosciences’ earnings beat estimates by 22.22%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
CHMP Endorses AstraZeneca's (AZN) Enhertu in Lung Cancer
AstraZeneca (AZN - Free Report) announced that the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion recommending label expansion for Enhertu (trastuzumab deruxtecan) in non-small cell lung cancer (“NSCLC”).
The CHMP recommends approving Enhertu to treat adult patients with advanced NSCLC whose tumors have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
The positive recommendation is based on data from the phase II DESTINY-Lung02 study, which evaluated Enhertu in patients with previously treated advanced or metastatic HER2-mutant (“HER2m”) NSCLC. Study participants who were treated with Enhertu achieved durable and robust tumor responses. Data from the study demonstrated that patients treated with Enhertu achieved a confirmed objective response rate (“ORR”) of 49.0% and a median duration of response (“mDOR”) of 16.8 months.
Enhertu is approved under the accelerated pathway for a similar indication in the United States, based on data from the DESTINY-Lung02 study.
Apart from the NSCLC indication, Enhertu is approved in the United States and European Union (“EU”) for three indications – two in breast cancer and one in the indication of gastric cancer.
AstraZeneca’s shares have inched up 0.7% year to date compared with the industry’s 8.1% growth.
Image Source: Zacks Investment Research
Currently, no HER2-targeted therapies are approved in the EU for NSCLC indication. A potential approval to Enhertu in NSCLC will provide the first targeted treatment option for this patient group.
A HER2-directed antibody drug conjugate (“ADC”), Enhertu, has been developed by AstraZeneca in collaboration with Daiichi Sankyo. Per an agreement entered in 2019, both companies jointly agreed to develop and commercialize Enhertu globally except in Japan, where Daiichi Sankyo maintains exclusive rights.
AstraZeneca PLC Price
AstraZeneca PLC price | AstraZeneca PLC Quote
Zacks Rank & Stock to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Annovis Bio (ANVS - Free Report) , Precision BioSciences (DTIL - Free Report) and Selecta Biosciences , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.79 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.04 to $2.77. Year to date, shares of Annovis have lost 21.1%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 30 days, estimates for Precision BioSciences’ 2023 loss per share have improved from 82 cents to 77 cents. During the same period, the loss estimates per share for 2024 have narrowed down from 48 cents to 31 cents. Year to date, shares of DTIL have lost 65.6%.
Earnings of Precision BioSciences beat estimates in two of the trailing four quarters while beating the mark on other two occasions, delivering an average earnings surprise of 20.20%. In the last reported quarter, Precision BioSciences’ earnings beat estimates by 56.52%.
In the past 30 days, estimates for Selecta Biosciences’ 2023 loss per share have improved from 39 cents to 33 cents. During the same period, the estimates per share for 2024 narrowed down from 35 cents to 7 cents. Year to date, shares of Selecta have risen 0.9%.
Earnings of Selecta Biosciences beat estimates in two of the trailing four quarters and missed in the remaining two, the average negative surprise being 47.57%. In the last reported quarter, Selecta Biosciences’ earnings beat estimates by 22.22%.