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Incyte (INCY), MorphoSys Win EC Approval for Lymphoma Drug
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Incyte (INCY - Free Report) and partner MorphoSys AG (MOR - Free Report) recently announced that the European Commission (“EC”) has granted conditional marketing authorization to tafasitamab under the brand name Minjuvi.
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody.
The drug has been approved in combination with Bristol Myers’ (BMY - Free Report) Revlimid (lenalidomide) followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
An approval was in the cards as the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion recommending the conditional marketing authorization of Minjuvi in June 2021.
The conditional approval is based on positive results from the L-MIND study evaluating the safety and efficacy of Minjuvi in combination with Revlimid as a treatment for patients with relapsed or refractory DLBCL who are not eligible for ASCT. The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee.
We remind investors that both the companies share global development rights to tafasitamab. While Incyte has exclusive commercialization rights to tafasitamab outside the United States, both the companies co-market the drug under the brand name Monjuvi in the United States. Incyte will market the drug under the brand name Minjuvi in the EU.
In Europe, approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL annually.
The approval will generate an incremental stream of revenues for Incyte.
Shares of the company have lost 12.8% in the year so far against the industry’s 0.7% growth.
Image Source: Zacks Investment Research
Incyte’s performance in the second quarter was encouraging as lead drug Jakafi sales recorded growth after a soft first quarter. The uptake of Pemazyre is also gaining traction. The company’s efforts to diversify its revenue base are encouraging as well.
However, the company has suffered a few setbacks of late. The FDA extended the review period for Incyte’s new drug application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD). The FDA also issued a complete response letter (CRL) for the biologics license application (BLA) for its intravenous PD-1 inhibitor, retifanlimab, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of platinum-based chemotherapy.
Image: Bigstock
Incyte (INCY), MorphoSys Win EC Approval for Lymphoma Drug
Incyte (INCY - Free Report) and partner MorphoSys AG (MOR - Free Report) recently announced that the European Commission (“EC”) has granted conditional marketing authorization to tafasitamab under the brand name Minjuvi.
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody.
The drug has been approved in combination with Bristol Myers’ (BMY - Free Report) Revlimid (lenalidomide) followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
An approval was in the cards as the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion recommending the conditional marketing authorization of Minjuvi in June 2021.
The conditional approval is based on positive results from the L-MIND study evaluating the safety and efficacy of Minjuvi in combination with Revlimid as a treatment for patients with relapsed or refractory DLBCL who are not eligible for ASCT. The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee.
We remind investors that both the companies share global development rights to tafasitamab. While Incyte has exclusive commercialization rights to tafasitamab outside the United States, both the companies co-market the drug under the brand name Monjuvi in the United States. Incyte will market the drug under the brand name Minjuvi in the EU.
In Europe, approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL annually.
The approval will generate an incremental stream of revenues for Incyte.
Shares of the company have lost 12.8% in the year so far against the industry’s 0.7% growth.
Image Source: Zacks Investment Research
Incyte’s performance in the second quarter was encouraging as lead drug Jakafi sales recorded growth after a soft first quarter. The uptake of Pemazyre is also gaining traction. The company’s efforts to diversify its revenue base are encouraging as well.
However, the company has suffered a few setbacks of late. The FDA extended the review period for Incyte’s new drug application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD). The FDA also issued a complete response letter (CRL) for the biologics license application (BLA) for its intravenous PD-1 inhibitor, retifanlimab, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of platinum-based chemotherapy.
Incyte currently has a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Repligen Corporation (RGEN - Free Report) which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates for Repligen for 2021 are up 50 cents in the past 30 days. The stock is up 42.6% in the year so far.