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Incyte (INCY), MorphoSys Initiate Dosing in Lymphoma Study
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Incyte (INCY - Free Report) and partner MorphoSys AG (MOR - Free Report) announced that the first patient has been dosed in the late-stage, inMIND study on tafasitamab.
Tafasitamab is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody.
The phase III study is evaluating the efficacy and safety of tafasitamab or placebo, in combination with Bristol Myers’ (BMY - Free Report) Revlimid (lenalidomide) and Rituxan, in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).
The study is expected to enroll more than 600 adult (age ≥18 years) patients with relapsed or refractory FL or MZL. The primary endpoint of the study is progression-free survival (PFS) in the FL population. Key secondary endpoints are PFS and overall survival (OS) in the overall population as well as positron emission tomography complete response (PET-CR) at the end of treatment (EOT) in the FL population.
The regulatory agency has granted an orphan drug designation to tafasitamab for the treatment of FL in January 2021.
We remind investors that tafasitamab-cxix in combination with Revlimid is approved in the United States under the brand name, Monjuvi, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
Incyte entered a collaboration and licensing agreement with MorphoSys in January 2020 to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States, while Incyte has exclusive commercialization rights outside the United States.
The European Medicines Agency (EMA) has also validated the marketing authorization application (MAA) seeking the approval of tafasitamab in combination with Revlimid in the EU for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low-grade lymphoma, who are not candidates for ASCT.
Shares of Incyte have lost 5% so far this year compared with the industry’s decline of 3.6%.
Incyte’s lead drug, Jakafi, maintains momentum on the back of strong demand for all approved indications. The approval of newer drugs like Pemazyre, Monjuvi (with MorphoSys) and Tabrecta will generate an additional revenue stream and diversify the company’s revenue base.
Repligen’s earnings estimates for 2021 have increased to $1.91 from $1.66 in the past 60 days.
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Incyte (INCY), MorphoSys Initiate Dosing in Lymphoma Study
Incyte (INCY - Free Report) and partner MorphoSys AG (MOR - Free Report) announced that the first patient has been dosed in the late-stage, inMIND study on tafasitamab.
Tafasitamab is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody.
The phase III study is evaluating the efficacy and safety of tafasitamab or placebo, in combination with Bristol Myers’ (BMY - Free Report) Revlimid (lenalidomide) and Rituxan, in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).
The study is expected to enroll more than 600 adult (age ≥18 years) patients with relapsed or refractory FL or MZL. The primary endpoint of the study is progression-free survival (PFS) in the FL population. Key secondary endpoints are PFS and overall survival (OS) in the overall population as well as positron emission tomography complete response (PET-CR) at the end of treatment (EOT) in the FL population.
The regulatory agency has granted an orphan drug designation to tafasitamab for the treatment of FL in January 2021.
We remind investors that tafasitamab-cxix in combination with Revlimid is approved in the United States under the brand name, Monjuvi, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
Incyte entered a collaboration and licensing agreement with MorphoSys in January 2020 to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States, while Incyte has exclusive commercialization rights outside the United States.
The European Medicines Agency (EMA) has also validated the marketing authorization application (MAA) seeking the approval of tafasitamab in combination with Revlimid in the EU for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low-grade lymphoma, who are not candidates for ASCT.
Shares of Incyte have lost 5% so far this year compared with the industry’s decline of 3.6%.
Incyte’s lead drug, Jakafi, maintains momentum on the back of strong demand for all approved indications. The approval of newer drugs like Pemazyre, Monjuvi (with MorphoSys) and Tabrecta will generate an additional revenue stream and diversify the company’s revenue base.
Incyte currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Repligen Corporation (RGEN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates for 2021 have increased to $1.91 from $1.66 in the past 60 days.
+1,500% Growth: One of 2021’s Most Exciting Investment Opportunities
In addition to the stocks you read about above, would you like to see Zacks’ top picks to capitalize on the Internet of Things (IoT)? It is one of the fastest-growing technologies in history, with an estimated 77 billion devices to be connected by 2025. That works out to 127 new devices per second.
Zacks has released a special report to help you capitalize on the Internet of Things’s exponential growth. It reveals 4 under-the-radar stocks that could be some of the most profitable holdings in your portfolio in 2021 and beyond.
Click here to download this report FREE >>