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. operates a biopharmaceutical business built around acquiring and advancing pharmaceutical and biotechnology assets. Company updates commonly cover product revenue, equity holdings, dividend and royalty income, FDA decisions, subsidiary transactions and clinical or regulatory progress across its portfolio.
Recurring news also includes Journey Medical dermatology products, Cyprium Therapeutics and ZYCUBO® for Menkes disease, priority review voucher monetization and corporate financial results. Fortress reports material developments involving approved prescription products, portfolio-company ownership, royalties, capital resources and business-development activity.
Fortress Biotech, Inc. (NASDAQ: FBIO) announced that Dr. Lindsay A. Rosenwald will participate in two investor conferences in March 2023. The 35th Annual ROTH Conference will include a fireside chat on March 13, 2023, at 9:00 a.m. PT, with a subsequent webcast available for 30 days. The Oppenheimer 33rd Annual Virtual Healthcare Conference will feature a presentation on March 15, 2023, at 12:40 p.m. ET, also followed by a 30-day webcast. Fortress Biotech focuses on acquiring, developing, and commercializing innovative therapeutic products, maintaining a diversified pipeline across various medical sectors.
Helocyte, a subsidiary of Fortress Biotech (Nasdaq: FBIO), announced the presentation of Phase 1 trial results for its CMV vaccine, Triplex, at the 2023 Tandem Meetings in Orlando. The trial highlighted that donor vaccination with Triplex significantly enhanced CMV-specific immunity in recipients of allogeneic hematopoietic cell transplants (HCT). Key findings showed an 18% rate of CMV events requiring antiviral intervention in recipients with vaccinated donors, compared to 37% in control cohorts. The promising results suggest potential for Triplex to reduce antiviral therapy needs and improve outcomes in immunocompromised transplant patients.
Helocyte, a subsidiary of Fortress Biotech (FBIO), announced a Phase 2 clinical trial to evaluate the efficacy of its Triplex vaccine in enhancing CMV-specific T cell immunity in stem cell transplant recipients. A Phase 1 pilot study demonstrated Triplex's feasibility, safety, and potential efficacy with significant increases in CMV-specific T cells in vaccinated donors. The trial revealed that only 18% of recipients with Triplex-vaccinated donors experienced CMV reactivation, compared to 37% in control groups. Helocyte's Triplex vaccine aims to improve post-transplant outcomes and decrease reliance on toxic antivirals.
On February 10, 2023, Fortress Biotech (Nasdaq: FBIO) announced the successful closure of a registered direct offering and a concurrent private placement. The company issued 16.6 million shares of common stock at $0.835 each, raising approximately $13.9 million in gross proceeds. Notably, directors and officers participated in the offering, purchasing around $3.3 million in shares. Additionally, the private placement includes rights to acquire 3.5% of the outstanding shares in future subsidiaries, contingent on specific corporate developments. Proceeds will be used for general corporate purposes and working capital.
Fortress Biotech, Inc. (Nasdaq: FBIO) has announced a registered direct offering of 16.6 million shares of common stock at $0.835 per share, totaling approximately $13.9 million in gross proceeds. Notably, certain company directors and officers invested about $3.3 million in this offering. Additionally, investors will receive rights to acquire around 3.5% of potential shares from the company's upcoming subsidiaries, contingent on specific corporate developments in the next five years. The offering is expected to close by February 10, 2023, subject to customary conditions. Proceeds will be used for general corporate purposes and working capital.
Journey Medical Corporation (Nasdaq: DERM) announced that Ernest De Paolantonio will step down as Chief Financial Officer effective January 27, 2023, to pursue another opportunity. Joseph M. Benesch has been appointed as Interim Chief Financial Officer from the same date. Claude Maraoui, CEO, noted Benesch's extensive experience and preparation for this leadership role. An internal and external search for a permanent CFO is underway. De Paolantonio will consult until March 31, 2023, ensuring a smooth transition. This change comes as Journey Medical anticipates significant milestones, including topline data from Phase 3 clinical trials in the first half of 2023.
Journey Medical Corporation (NASDAQ: DERM) has completed enrollment for its Phase 3 clinical trials assessing the safety and efficacy of DFD-29 for the treatment of papulopustular rosacea. The trials will compare DFD-29 with current treatments and aim to file a New Drug Application in late 2023. Preliminary Phase 2 trial results indicated DFD-29 is nearly twice as effective as doxycycline. The combined trials target 640 adult patients, and the company anticipates peak annual sales could exceed $100 million upon approval.
Journey Medical Corporation (NASDAQ: DERM) announced positive pharmacokinetic (PK) comparability data for its drug DFD-29 in a Phase 3 study focused on treatment for papulopustular rosacea. Conducted in collaboration with Dr. Reddy’s Laboratories, the study showed DFD-29's systemic exposure was significantly lower than SOLODYN, with no food effect on its pharmacokinetics. With enrollment at 96%, Journey Medical anticipates topline data in the first half of 2023 and plans to file a New Drug Application later in the year, aiming to provide an effective treatment for millions suffering from rosacea.
Fortress Biotech, Inc. (Nasdaq: FBIO) announced the appointment of Lucy Lu, M.D., to its Board of Directors. Dr. Lu brings over 20 years of experience in biotech and healthcare, previously serving as CEO of Avenue Therapeutics and CFO of Fortress. Her expertise in drug development and finance is expected to enhance the strategic direction of Fortress as it continues to advance its pipeline of eight marketed products and over 20 clinical-stage candidates. Fortress aims to leverage Dr. Lu's experience to create shareholder value and pursue new opportunities globally.
Urica Therapeutics, a subsidiary of Fortress Biotech (Nasdaq: FBIO), has expanded its exclusive license agreement with Fuji Yakuhin Co. Ltd. to develop dotinurad for gout treatment in the Middle East and North Africa (MENA) and Turkey. This follows a prior agreement covering the US, UK, EU, and Canada. Dotinurad, which is in Phase 1 trials in the US and launched in Japan in 2020, is designed to inhibit uric acid reabsorption and has been well-tolerated in clinical studies. Urica aims to expedite regulatory approvals for dotinurad in the new territories.