Incyte INCY and partner MorphoSys AG MOR 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 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, 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.
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Incyte Corporation (INCY): Free Stock Analysis Report
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