Welcome to our dedicated page for Fortress Biotech news (Ticker: FBIO), a resource for investors and traders seeking the latest updates and insights on Fortress Biotech stock.
Fortress Biotech Inc (FBIO) delivers innovative biopharmaceutical solutions through strategic acquisitions and subsidiary-driven development. This news hub provides investors and industry observers with centralized access to verified corporate updates across all therapeutic focus areas.
Track the latest press releases, regulatory milestones, and partnership announcements from Fortress Biotech and its network of specialized subsidiaries. Our curated feed includes updates on dermatology advancements, oncology research breakthroughs, and rare disease therapeutic developments. Stay informed about licensing agreements, clinical trial progress, and product commercialization efforts.
This resource serves as your primary source for FDA submissions, earnings reports, and strategic collaborations shaping FBIO's diversified pipeline. Bookmark this page for real-time updates on drug development progress and corporate initiatives that drive value across Fortress Biotech's unique operational ecosystem.
Cyprium Therapeutics and Sentynl Therapeutics have entered a $20 million asset purchase agreement for CUTX-101, a treatment for Menkes disease. The deal includes upfront payments and potential sales milestones and royalties based on sales. Cyprium retains responsibility for the development of CUTX-101 through NDA approval, while Sentynl will handle commercialization. This partnership aims to expedite the drug's availability, addressing a critical need in pediatric care. The FDA submission for CUTX-101 is projected to start in Q3 2021, with potential breakthrough treatment benefits for affected children.
Fortress Biotech, Inc. (Nasdaq: FBIO) has appointed Markus Peters, Ph.D., as President and CEO of its partner company, Aevitas Therapeutics, which focuses on gene therapy for complement-mediated diseases. Dr. Peters, with significant experience in AAV-based therapies, replaces a prior leader to advance Aevitas' innovative platform aimed at providing a shortened complement factor H gene. Additionally, Catherine Bowes Rickman, Ph.D., a leading researcher in age-related macular degeneration, joins the Scientific Advisory Board to enhance R&D efforts.
Fortress Biotech (NASDAQ: FBIO) announced participation in three virtual investor conferences in January 2021. CEO Lindsay A. Rosenwald will host one-on-one meetings during the 10th Annual LifeSci Partners Corporate Access Event from January 6-14. Additionally, Fortress will present at the 2021 CTIC 5th Healthcare Investment Digital Summit on January 9 at 8:00 p.m. EST and will offer an on-demand presentation at the H.C. Wainwright Virtual BioConnect Conference starting January 11 at 6:00 a.m. EST. Fortress focuses on developing innovative biopharmaceuticals and has a robust pipeline in oncology and rare diseases.
Fortress Biotech (Nasdaq: FBIO) announced that the FDA has granted Breakthrough Therapy Designation for CUTX-101, a potential treatment for Menkes disease. The rolling submission of the New Drug Application (NDA) is scheduled to start in Q1 2021 and complete by the end of Q2 2021. This designation aims to expedite the development of drugs for serious conditions. Previous designations for CUTX-101 include Orphan Drug, Fast Track, and Rare Pediatric Disease.
Menkes disease is a rare genetic disorder with no FDA-approved treatments.
Fortress Biotech, Inc. (NASDAQ: FBIO) has been recognized in Deloitte's 2020 Technology Fast 500™, ranking 135th due to an impressive 874% revenue growth from 2016 to 2019. This marks the second consecutive year Fortress has achieved this recognition. The company emphasizes its commitment to generating shareholder value by acquiring and developing a diverse portfolio of biopharmaceutical products, including five marketed products and over 25 development-stage programs. The Fast 500 rankings highlight the company's rapid growth amid a competitive landscape.
Fortress Biotech (FBIO) reported a 29% year-over-year increase in product revenue, totaling $30.8 million for the first nine months of 2020. The company strengthened its balance sheet with a $12 million preferred stock offering and a $60 million refinancing agreement. Significant growth was seen despite the COVID-19 pandemic's impact on third-quarter sales. The company anticipates submitting a New Drug Application for CUTX-101 in Q1 2021. Clinical advancements for its products, including cosibelimab and CAEL-101, show promise, boosting its growth outlook.
Fortress Biotech (NASDAQ: FBIO) announced the acceptance of clinical data on CAEL-101 for AL amyloidosis and MB-106 CAR T cell therapy for non-Hodgkin lymphoma, to be presented at the 62nd ASH Annual Meeting from December 5-8, 2020. The Cleveland Clinic will present Phase 2 data for CAEL-101, which has recently progressed to Phase 3, while interim data for MB-106 will be presented by Fred Hutch. Both therapies aim to offer new treatment options for patients with severe conditions. CEO Lindsay A. Rosenwald highlighted the significance of these developments.
Samsung Biologics and Checkpoint Therapeutics have expanded their manufacturing partnership for the anti-PD-L1 antibody, cosibelimab, originally established in 2017. Under the new agreement, commercial-scale drug substance manufacturing will commence at Samsung's Plant 1 in 2021. This partnership aims to support Checkpoint's pivotal clinical trials and potential regulatory approvals for cosibelimab, which targets metastatic cutaneous squamous cell carcinoma. Checkpoint plans to release pivotal trial topline results by mid-2021.
Fortress Biotech (NASDAQ: FBIO) announced a webinar on October 21, 2020, hosted by Scott Henry of ROTH Capital, featuring Journey Medical Corporation executives. The session aims to discuss Journey Medical's innovative dermatology products and strategic commercialization efforts. Fortress Biotech is recognized for its rapid growth, ranking 10th in Deloitte’s 2019 Technology Fast 500, and has a diverse portfolio with five marketed products and over 25 in development. For more details, visit Fortress's website for the live stream and an archived replay.
Fortress Biotech's Caelum Biosciences, in partnership with Alexion Pharmaceuticals, has initiated the CARES Phase 3 clinical program for CAEL-101, targeting AL amyloidosis. This program comprises two parallel studies enrolling ~370 patients, aiming to assess overall survival and safety. Previous Phase 2 results confirmed CAEL-101's safety and tolerability, supporting its 1000 mg/m2 dose for Phase 3. Long-term Phase 1a/1b data revealed a 78% survival rate at 37 months, bolstering the drug's potential to improve organ function and overall survival.
