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August 16 , 2021 FORTRESS BIOTECH Fortress Biotech Reports Record Second Quarter 2021 Financial Results and Recent Corporate Highlights Net revenue for second quarter of 2021 increased 89 % year - over - year to $ 17.8 million , a quarterly record Rolling NDA submission for CUTX - 101 for the treatment of Menkes disease expected to begin in the second half of 2021 On track to report top - line results from registration - enabling study of cosibelimab in metastatic cutaneous squamous cell carcinoma by year - end 2021 -- NEW YORK , Aug. 16 , 2021 ( GLOBE NEWSWIRE ) Fortress Biotech , Inc. ( NASDAQ : FBIO ) ( " Fortress " ) , an innovative biopharmaceutical company focused on acquiring , developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost - effectively , today announced financial results and recent corporate highlights for the second quarter ended June 30 , 2021 . Lindsay A. Rosenwald , M.D. , Fortress ' Chairman , President and Chief Executive Officer , said , " We generated significant sales momentum in the second quarter , recording quarterly record net revenues of $ 17.8 million , an 89 % increase year - over - year . We also successfully acquired and recently launched QBREXZAⓇ to further expand our portfolio of marketed products , as well as in - licensed Dotinurad , DFD - 29 , and a novel CAR T technology , which enhance our robust pipeline of drug candidates . In addition , we presented compelling clinical data for CAEL - 101 for the treatment of AL amyloidosis and MB - 106 for relapsed or refractory B - cell non - Hodgkin lymphomas ( " B - NHL " ) and chronic lymphocytic leukemia ( " CLL " ) at the European Hematology Association 2021 Virtual Congress ( " EHA2021 " ) . Looking ahead , we anticipate several additional regulatory and clinical catalysts throughout the remainder of 2021 , including the availability of pivotal data from cosibelimab for the treatment of metastatic cutaneous squamous cell carcinoma . We also expect to begin the rolling New Drug Application ( " NDA ” ) submission for CUTX - 101 for the treatment of Menkes disease in the second half of 2021. " Dr. Rosenwald continued , " We have an expanding portfolio of seven marketed dermatology products and more than 25 product candidates across our partner companies , including 18 clinical programs and 24 clinical trials , of which four are pivotal clinical trials , and up to four more could potentially be pivotal soon . Our diversified business model is supported by a