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AbbVie (ABBV) Gets Nod in EU for Lymphoma Drug's Expanded Use
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AbbVie (ABBV - Free Report) and partner, Genmab (GMAB - Free Report) , announced that the European Commission has granted conditional marketing authorization for the expanded use of Tepkinly (epcoritamab) to treat relapsed or refractory follicular lymphoma (FL) after two or more therapies. R/R FL is a particularly difficult-to-treat form of cancer, especially in later lines of therapy, for which there is currently no standard of care treatment.
The encouraging regulatory update follows the positive opinion that was adopted by the advisory committee to the regulatory body in the EU in June 2024, recommending the approval of the same for the above indication.
Please note that Tepkinly is already approved in the EU for R/R third-line diffuse large B-cell lymphoma (DLBCL). With this latest approval for the second indication, Tepkinly becomes the first and only subcutaneous T-cell engaging bispecific antibody approved to treat both R/R FL and R/R DLBCL in the EU.
In the United States, AbbVie and Genmab’s Tepkinly is marketed under the brand name Epkinly to treat the same R/R FL and R/R DLBCL indications.
FL is an incurable form of indolent (slow-growing) non-Hodgkin's lymphoma (NHL), which is the second most common form of NHL. DLBCL, on the other hand, is the most common form of aggressive (fast-growing) NHL.
Year to date, shares of ABBV have gained 27% compared with the industry’s 24.7% growth.
Image Source: Zacks Investment Research
The conditional approval of Tepkinly in the EU for R/R FL was based on the success of the phase I/II EPCORE NHL-1 clinical study that evaluated the drug as monotherapy in patients with R/R FL after two or more lines of prior systemic therapy.
The study achieved its primary endpoint witnessing an overall response rate of 83%. The study also achieved a complete response rate of 63%. Moreover, at a median follow-up of 16.2 months, the median duration of response was 21.4 months. However, the duration of complete response was not achieved at the time of the data readout.
The safety profile of the drug as a monotherapy in the pivotal cohort of the FL study was found to be consistent with that reported in the pivotal cohort of the DLBCL study. Treatment-related adverse events were mostly mid-moderate in severity. However, AbbVie reported that 14 patients experienced a fatal adverse reaction in the phase I/II EPCORE NHL-1 study.
Tepkinly/Epkinly is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration deal signed in 2020 to jointly develop and market three of the latter’s early-stage investigational bispecific antibody product candidates.
Under the existing collaboration agreement, the companies will share commercial responsibilities in the United States and Japan, with AbbVie responsible for further global commercialization. Both ABBV and Genmab will pursue regulatory approvals for the R/R FL and R/R DLBCL indications in additional geographies.
Currently, phase III studies on epcoritamab in earlier lines of DLBCL are ongoing. Both companies also continue to evaluate Tepkinly/Epkinly as a monotherapy and in combination across lines of therapy in a range of hematologic malignancies.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.49. Year to date, shares of ILMN have lost 2.4%.
Illumina’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Arcturus Therapeutics’ 2024 loss per share have improved from $4.39 to $2.60. The estimate for 2025 is currently pegged at earnings of 21 cents per share. Year to date, shares of Arcturus Therapeutics have plunged 32.1%.
Earnings of Arcturus Therapeutics beat estimates in each of the last four quarters, delivering an average earnings surprise of 56.73%.
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AbbVie (ABBV) Gets Nod in EU for Lymphoma Drug's Expanded Use
AbbVie (ABBV - Free Report) and partner, Genmab (GMAB - Free Report) , announced that the European Commission has granted conditional marketing authorization for the expanded use of Tepkinly (epcoritamab) to treat relapsed or refractory follicular lymphoma (FL) after two or more therapies. R/R FL is a particularly difficult-to-treat form of cancer, especially in later lines of therapy, for which there is currently no standard of care treatment.
The encouraging regulatory update follows the positive opinion that was adopted by the advisory committee to the regulatory body in the EU in June 2024, recommending the approval of the same for the above indication.
Please note that Tepkinly is already approved in the EU for R/R third-line diffuse large B-cell lymphoma (DLBCL). With this latest approval for the second indication, Tepkinly becomes the first and only subcutaneous T-cell engaging bispecific antibody approved to treat both R/R FL and R/R DLBCL in the EU.
In the United States, AbbVie and Genmab’s Tepkinly is marketed under the brand name Epkinly to treat the same R/R FL and R/R DLBCL indications.
FL is an incurable form of indolent (slow-growing) non-Hodgkin's lymphoma (NHL), which is the second most common form of NHL. DLBCL, on the other hand, is the most common form of aggressive (fast-growing) NHL.
Year to date, shares of ABBV have gained 27% compared with the industry’s 24.7% growth.
Image Source: Zacks Investment Research
The conditional approval of Tepkinly in the EU for R/R FL was based on the success of the phase I/II EPCORE NHL-1 clinical study that evaluated the drug as monotherapy in patients with R/R FL after two or more lines of prior systemic therapy.
The study achieved its primary endpoint witnessing an overall response rate of 83%. The study also achieved a complete response rate of 63%. Moreover, at a median follow-up of 16.2 months, the median duration of response was 21.4 months. However, the duration of complete response was not achieved at the time of the data readout.
The safety profile of the drug as a monotherapy in the pivotal cohort of the FL study was found to be consistent with that reported in the pivotal cohort of the DLBCL study. Treatment-related adverse events were mostly mid-moderate in severity. However, AbbVie reported that 14 patients experienced a fatal adverse reaction in the phase I/II EPCORE NHL-1 study.
Tepkinly/Epkinly is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration deal signed in 2020 to jointly develop and market three of the latter’s early-stage investigational bispecific antibody product candidates.
Under the existing collaboration agreement, the companies will share commercial responsibilities in the United States and Japan, with AbbVie responsible for further global commercialization. Both ABBV and Genmab will pursue regulatory approvals for the R/R FL and R/R DLBCL indications in additional geographies.
Currently, phase III studies on epcoritamab in earlier lines of DLBCL are ongoing. Both companies also continue to evaluate Tepkinly/Epkinly as a monotherapy and in combination across lines of therapy in a range of hematologic malignancies.
AbbVie Inc. Price and Consensus
AbbVie Inc. price-consensus-chart | AbbVie Inc. Quote
Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector are Illumina, Inc. (ILMN - Free Report) and Arcturus Therapeutics (ARCT - 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 Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.49. Year to date, shares of ILMN have lost 2.4%.
Illumina’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Arcturus Therapeutics’ 2024 loss per share have improved from $4.39 to $2.60. The estimate for 2025 is currently pegged at earnings of 21 cents per share. Year to date, shares of Arcturus Therapeutics have plunged 32.1%.
Earnings of Arcturus Therapeutics beat estimates in each of the last four quarters, delivering an average earnings surprise of 56.73%.