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Friday, June 25, 2021

MorphoSys, Incyte: Positive CHMP Opinion for Tafasitamab Combo for Large B-Cell Lymphoma

 MorphoSys AG (FSE: MOR; NASDAQ: MOR) and Incyte

(NASDAQ: INCY) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use 
(CHMP) has issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination 
with lenalidomide, followed by tafasitamab 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 transplantation (ASCT). 
"The CHMP's positive opinion of tafasitamab is a pivotal step towards addressing an urgent unmet medical need for the 
30-40% of patients with relapsed or refractory DLBCL who do not respond to initial therapy or relapse thereafter," said 
Steven Stein, M.D., Chief Medical Officer, Incyte. "Following the U.S. FDA's approval of tafasitamab in July 2020, we 
eagerly await the European Commission's decision as we look forward to bringing this new therapy to eligible patients 
in Europe as soon as possible." 
https://www.marketscreener.com/quote/stock/MORPHOSYS-AG-436425/news/PRESS-RELEASE-nbsp-MorphoSys-and-Incyte-Announce-Positive-CHMP-Opinion-for-Tafasitamab-in-Combinat-35700740/

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