We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
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.
AbbVie's Ovarian Cancer Drug Elahere Gets Approval in Europe
Read MoreHide Full Article
AbbVie (ABBV - Free Report) announced that the European Commission (“EC”) has granted marketing authorization to Elahere (mirvetuximab soravtansine) for treating platinum-resistant ovarian cancer.
The EC has approved Elahere for treating adult patients with folate receptor-alpha (FRα) positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatments.
Following the approval, Elahere became the first and only FRα-directed antibody drug conjugate (ADC) approved specifically for patients with FRα positive, platinum-resistant ovarian cancer in the European Union.
Elahere was granted full approval by the FDA for a similar indication in March 2024. The drug was initially approved for this indication under the accelerated pathway in 2022.
Shares of AbbVie have gained 6.5% so far this year compared with the industry’s rise of 3.4%.
Image Source: Zacks Investment Research
EU Nod Based on ABBV's MIRASOL Study
The latest approval in Europe was based on data from the phase III MIRASOL study, which evaluated Elahere against the investigator's choice of single-agent chemotherapy in the given patient population.
Data from the study showed that treatment with Elahere reduced the risk of tumor progression or death by 35% compared with investigator's choice of chemotherapy — the primary endpoint of the MIRASOL study.
Also, treatment with Elahere improved overall survival — demonstrating a 33% reduction in the risk of death versus the investigator's choice of chemotherapy.
The approval in Europe was expected as in September the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended approval for Elahere for the given indication.
ADCs are next-generation treatments that target cancer cells by delivering highly potent cancer-killing agents through a targeted antibody.
In June, AbbVie reported positive results from the phase II PICCOLO study, which evaluated Elahere in heavily pre-treated patients with FRα-positive platinum-sensitive ovarian cancer. The study achieved its primary endpoint as patients treated with Elahere achieved an objective response rate of 51.9%.
Elahere generated sales worth $331 million during the first nine months of 2024. The drug is also being studied for earlier lines of therapy in ovarian cancer. Potential label expansion of the drug is likely to boost sales in future quarters.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 53.8%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.59 to $4.71. Earnings per share estimates for 2025 have improved from $4.82 to $5.65 during the same time. Year to date, shares of ANIP have increased 2.6%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 30.2%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Shutterstock
AbbVie's Ovarian Cancer Drug Elahere Gets Approval in Europe
AbbVie (ABBV - Free Report) announced that the European Commission (“EC”) has granted marketing authorization to Elahere (mirvetuximab soravtansine) for treating platinum-resistant ovarian cancer.
The EC has approved Elahere for treating adult patients with folate receptor-alpha (FRα) positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatments.
Following the approval, Elahere became the first and only FRα-directed antibody drug conjugate (ADC) approved specifically for patients with FRα positive, platinum-resistant ovarian cancer in the European Union.
Elahere was granted full approval by the FDA for a similar indication in March 2024. The drug was initially approved for this indication under the accelerated pathway in 2022.
Shares of AbbVie have gained 6.5% so far this year compared with the industry’s rise of 3.4%.
Image Source: Zacks Investment Research
EU Nod Based on ABBV's MIRASOL Study
The latest approval in Europe was based on data from the phase III MIRASOL study, which evaluated Elahere against the investigator's choice of single-agent chemotherapy in the given patient population.
Data from the study showed that treatment with Elahere reduced the risk of tumor progression or death by 35% compared with investigator's choice of chemotherapy — the primary endpoint of the MIRASOL study.
Also, treatment with Elahere improved overall survival — demonstrating a 33% reduction in the risk of death versus the investigator's choice of chemotherapy.
The approval in Europe was expected as in September the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended approval for Elahere for the given indication.
More Updates on ABBV's Elahere
A first-in-class ADC, Elahere, was added to AbbVie’s portfolio in February this year following the acquisition of ImmunoGen for $10.1 billion.
ADCs are next-generation treatments that target cancer cells by delivering highly potent cancer-killing agents through a targeted antibody.
In June, AbbVie reported positive results from the phase II PICCOLO study, which evaluated Elahere in heavily pre-treated patients with FRα-positive platinum-sensitive ovarian cancer. The study achieved its primary endpoint as patients treated with Elahere achieved an objective response rate of 51.9%.
Elahere generated sales worth $331 million during the first nine months of 2024. The drug is also being studied for earlier lines of therapy in ovarian cancer. Potential label expansion of the drug is likely to boost sales in future quarters.
ABBV's Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are Immunocore Holdings plc (IMCR - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Castle Biosciences, Inc. (CSTL - Free Report) , each carrying 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 Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 53.8%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.59 to $4.71. Earnings per share estimates for 2025 have improved from $4.82 to $5.65 during the same time. Year to date, shares of ANIP have increased 2.6%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 30.2%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.