Business
Fortress Biotech Reports First Quarter 2021 Financial Results and Recent Corporate Highlights
Rolling NDA submission for CUTX-101 for the treatment of Menkes disease is expected to begin in the second half of 2021 On track to report top-line results
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"Rolling NDA submission for CUTX-101 for the treatment of Menkes disease is expected to begin in the second half of 2021 On track to report top-line results from the registration-enabling study of cosibelimab in metastatic cutaneous squamous cell carcinoma by year-end 2021 Ended first quarter 2021 with $291.5 million in consolidated cash, cash equivalents and restricted cash NEW YORK, May 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 first quarter ended March 31, 2021. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “Fortress and our partner companies had an exciting start to the year, including the addition and commercial launch of two dermatology products, bringing our total number of marketed products to seven. Moreover, we continued to achieve significant milestones in the advancement of multiple key development programs. Notably, in February, our partner company, Cyprium Therapeutics (“Cyprium”), and Sentynl Therapeutics (“Sentynl”), a wholly owned subsidiary of the Zydus Group, signed a Development and Asset Purchase Agreement for CUTX-101 for the treatment of Menkes disease. This agreement, which included an $8 million upfront payment for the ongoing development of CUTX-101, in addition to regulatory and sales milestone payments plus royalties, allows us to potentially maximize the value of this important asset as Cyprium continues to advance CUTX-101 toward a rolling submission of a New Drug Application (“NDA”) later this year.” Dr. Rosenwald continued, “Our portfolio continues to grow with more than 25 product candidates across our partner companies, including 17 clinical programs, of which four are pivotal programs. We expect to have a multitude of regulatory and clinical inflection points throughout the remainder of 2021, including the availability of clinical data from cosibelimab, CAEL-101 and MB-106. Importantly, our diversified business model is supported by a strong balance sheet, as we ended the first quarter with $291.5 million in consolidated cash, cash equivalents and restricte...