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. (Nasdaq: FBIO) is a biopharmaceutical company that regularly issues news about its portfolio of prescription pharmaceutical products and development programs. Its press releases cover updates from Fortress itself and from majority-owned and partner companies that it has founded or supports, providing investors with a consolidated view of activity across oncology, dermatology and rare disease assets.
Recent announcements highlight regulatory milestones, clinical progress and transaction-driven events. Fortress and its majority-owned subsidiary Cyprium Therapeutics have reported U.S. Food and Drug Administration (FDA) approval of ZYCUBO (copper histidinate, formerly CUTX-101) for the treatment of Menkes disease in pediatric patients, noting that it is the first and only FDA-approved treatment for Menkes disease in the United States. Earlier updates described FDA acceptance of the resubmission of the New Drug Application for CUTX-101 and the transfer of development and commercialization responsibilities to Sentynl Therapeutics, with Cyprium eligible for royalties and milestone payments.
News related to Journey Medical Corporation, which was founded by Fortress, includes financial results driven by net revenues from dermatology products and the commercial launch of Emrosi (DFD-29) for inflammatory lesions of rosacea in adults. Releases also present clinical data, such as pooled Phase 3 analyses demonstrating Emrosi’s efficacy versus comparators, and discuss payer access and prescription trends.
Additional Fortress news items describe monetization events and pipeline updates, such as the acquisition of Checkpoint Therapeutics by Sun Pharma, the sale of dotinurad rights to Crystalys Therapeutics with associated equity and royalty interests, and the initiation of Phase 3 trials of dotinurad for gout by Crystalys. Investors following FBIO news can use this page to review these types of announcements, track regulatory interactions, and monitor how Fortress’ subsidiaries and partners contribute to the overall portfolio.
Fortress Biotech has announced the pricing of an underwritten public offering of 666,666 shares of its 9.375% Series A Preferred Stock at $18.00 per share, aiming for gross proceeds of approximately $12 million. The company has also given underwriters a 45-day option to purchase an additional 66,666 shares. The offering is set to close around August 31, 2020. Proceeds will be utilized for operational needs, including R&D and clinical trials. The Benchmark Company and ThinkEquity are acting as joint bookrunners for the offering.
Fortress Biotech, Inc. (FBIO) announced a virtual two-day summit on August 18-19, 2020, hosted by Mayank Mamtani of B. Riley FBR, featuring discussions on its diverse pipeline. The first day includes panels from Journey Medical Corporation, Cyprium Therapeutics, Avenue Therapeutics, and Mustang Bio. The second day focuses on oncology strategies, with presentations from Mustang Bio and Checkpoint Therapeutics. Fortress has a robust biopharmaceutical portfolio and recently ranked 10th in Deloitte’s 2019 Technology Fast 500. Webcast details are available on its investor page.
Fortress Biotech reported a 50% increase in product revenue to $21.4 million for the first half of 2020, driven by growth in its dermatology segment. Despite the pandemic's impact, the company executed an agreement with Columbia University to develop a novel oligonucleotide platform targeting genetically driven cancers. The upcoming months hold key milestones, including data from cosibelimab trials and the NDA submission for CUTX-101 for Menkes disease. However, Fortress reported a net loss of $13.3 million in Q2 2020, slightly higher than the previous year.
Fortress Biotech (FBIO) announces that the European Medicines Agency's Committee for Orphan Medicinal Products positively reviewed Cyprium Therapeutics' application for Orphan Drug Designation for Copper Histidinate (CUTX-101), a treatment for Menkes disease. Menkes disease is a severe genetic disorder affecting copper metabolism. The FDA has also granted various designations for CUTX-101. The EMA’s designation provides several benefits, including market exclusivity and assistance with clinical protocols.
Cyprium Therapeutics, a partner company of Fortress Biotech (Nasdaq: FBIO), is advancing the clinical development of CUTX-101 for Menkes disease, with a New Drug Application (NDA) submission expected in Q4 2020. A recent study published in Molecular Genetics and Metabolism Reports validates the use of targeted next-generation sequencing for newborn screening of Menkes disease, which is crucial for early diagnosis and treatment. The study shows a 95.5% detection rate for pathogenic variants, suggesting that early identification could significantly improve patient outcomes.
Fortress Biotech (Nasdaq: FBIO) has been added to the Russell 3000 index effective June 29, 2020. This inclusion enhances the company's visibility among investors and institutions, potentially increasing stockholder value. The Russell 3000 comprises the largest U.S. stocks, ranking them by market capitalization. Fortress has a portfolio of five marketed drugs and over 25 development programs in areas like oncology and gene therapy. CEO Lindsay A. Rosenwald expressed optimism about this milestone and its implications for future growth.
Fortress Biotech (Nasdaq: FBIO) announced that Lindsay Rosenwald, M.D., will present a company overview at the Raymond James Human Health Innovation Conference on June 18, 2020, at 11:00 a.m. EDT, in a virtual format. Fortress is focused on acquiring and developing high-potential pharmaceutical products, with over 25 programs in development across areas like oncology and rare diseases. Recently ranked 10th in Deloitte's 2019 Technology Fast 500™, Fortress aims to maximize partnerships and advance its diversified pipeline.
Fortress Biotech, Inc. (FBIO) announced the publication of a study evaluating Menkes disease prevalence, revealing an estimated birth rate of 1 in 34,810 males. Previous estimates ranged from 1 in 40,000 to 1 in 354,507. The study suggests Menkes disease is under-reported, potentially due to healthcare access issues. Early diagnosis through newborn screening is recommended to enhance patient outcomes. CUTX-101, a treatment currently in development, aims to restore copper levels in affected patients and has shown promise in clinical trials.
Fortress Biotech has announced a public offering of 555,556 shares of its 9.375% Series A Preferred Stock at $18.00 per share, aiming for approximately $10 million in gross proceeds. Underwriters have a 45-day option for an additional 83,333 shares. The offering is set to close on or about May 29, 2020. Proceeds will fund operations, including R&D and clinical trials. The offering is managed by The Benchmark Company and ThinkEquity. This statement does not constitute an offer to sell securities where prohibited by law.
On May 8, 2020, Fortress Biotech, Inc. (FBIO) announced that its partner, Oncogenuity, has signed an exclusive licensing agreement with Columbia University. The focus is on developing ONCOlogues, advanced oligonucleotides targeting genetically driven cancers, particularly KRAS mutations considered 'un-druggable.' These ONCOlogues, which show potential efficacy in combating coronaviruses, are noted for their ability to bind gene sequences more effectively than traditional methods. Oncogenuity has established proof-of-concept in pre-clinical settings and plans to publish additional data within the next year.
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