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Fortress Biotech Reports Record Fourth Quarter and Full-Year 2019 Financial Results and Recent Corporate Highlights
Revenue from marketed dermatology products increased 85% for fourth quarter 2019 and 49% for full-year 2019 compared to 2018 NDA for IV tramadol accepted for
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"Revenue from marketed dermatology products increased 85% for fourth quarter 2019 and 49% for full-year 2019 compared to 2018\n NDA for IV tramadol accepted for review by FDA; PDUFA date is set for October 10, 2020 Rolling NDA submission for CUTX-101 for the treatment of Menkes disease is on track to begin in the fourth quarter of 2020 NEW YORK, March 16, 2020 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative biopharmaceutical company, today announced financial results and recent corporate highlights for the fourth quarter and full year ended December 31, 2019. Fortress achieved multiple key milestones in 2019 and early 2020, including: Our five marketed specialty dermatology products generated 2019 net revenues of $34.9 million, representing growth of 49% compared to 2018. Fourth quarter 2019 revenues generated from our five marketed specialty dermatology products were $11.1 million, representing 85% growth over fourth quarter 2018. The products are marketed by our partner company, Journey Medical Corporation.We ranked number 10 in Deloitte’s 2019 Technology Fast 500™, an annual ranking of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, given Fortress’ 8,463% revenue growth due to the increase in Journey Medical’s net product sales from 2015 to 2018.We submitted a New Drug Application (“NDA”) for IV tramadol to the U.S. Food and Drug Administration (“FDA”) in December 2019, which represents our first NDA filing. The FDA accepted the NDA for review and assigned a Prescription Drug User Fee Act (“PDUFA”) goal action date of October 10, 2020. Shortly after NDA approval of IV tramadol, and pending our fulfillment of the criteria as defined in the Stock Purchase and Merger Agreement, we plan to close the second stage of the strategic transaction between InvaGen Pharmaceuticals Inc. (“InvaGen”) and our partner company Avenue Therapeutics, Inc. (“Avenue”), for an aggregate cash purchase of up to $180 million payable to Avenue shareholders, including $48 million to Fortress directly, as well as future contingent value rights. The FDA granted Rare Pediatric Disease Designation to Copper Histidinate, also referred to as CUTX-101, for the treatment of Menkes disease. We intend to begin a rolling NDA submission for CUTX-101 ...