Fortress Biotech Joins Global Movement to Raise Awareness for Rare Diseases and Supports Rare Disease Day®

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[{"type":"text","content":"NEW YORK, Feb. 26, 2021 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative revenue-generating company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, today announced its support for Rare Disease Day® on February 28, an annual awareness day dedicated to elevating public understanding of rare diseases and calling attention to the special challenges people living with rare diseases face. “Fortress Biotech stands with over 25 million Americans living with a rare disease and is a proud sponsor of the National Organization for Rare Disorders’ (NORD®) 2021 Rare Disease Day activities. In collaboration with our partner companies, we are advancing innovative treatments for underserved rare diseases including AL amyloidosis, Menkes disease and X-linked severe combined immunodeficiency (“XSCID”), also known as bubble boy disease,” said Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer. “On this Rare Disease Day and every day, we are grateful to the patients participating in our clinical trials and their familes for their commitment to helping others. We look forward to bringing therapies to patients with rare diseases who currently have no FDA-approved treatment options.” Fortress and its partner companies have multiple rare disease clinical programs underway including: The Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program in AL amyloidosis, a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Enrollment is ongoing in two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease. (ClinicalTrials.gov Identifier: NCT04512235 and NCT04504825) A topline efficacy analysis was reported for Menkes disease, a rare X-linked recessive pediatric disease caused by gene mutations of copper transporter ATP7A that is often lethal if left untreated. A rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration is anticipated to begin in the third quarter of 2021 and be completed in the fourth quarter of 2021. (ClinicalTrials.gov Identifier: NCT04074512)Two pivotal Phase 2 clinical trials are anticipated to commence this year for XSCID, a rare ...

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