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.
Journey Medical Corporation (Nasdaq: DERM) has announced plans to release its year-end 2022 financial results on March 29, 2023, after U.S. market close. The Company will host a conference call at 4:30 p.m. ET to discuss the results and provide a corporate update. Interested parties can join the call by dialing 1-866-777-2509 (U.S.) or 1-412-317-5413 (international) approximately 10 minutes prior to start time. A live audio webcast and replays will be available on the Company’s website. Journey Medical focuses on dermatological pharmaceutical products and is based in Scottsdale, Arizona.
Journey Medical Corporation (Nasdaq: DERM) has completed treatment in its Phase 1 clinical trial of DFD-29, aimed at treating papulopustular rosacea. The trial involved 60 healthy adults and assessed both safety and tolerability, with no significant safety issues reported. Topline results from this trial are expected in the first half of 2023. Additionally, the Phase 3 trials for DFD-29 have been fully enrolled, with data anticipated in the same timeframe, leading to a potential New Drug Application filing later in 2023. Rosacea affects over 16 million Americans, emphasizing the market need for effective treatments.
Journey Medical Corporation (Nasdaq: DERM), a biopharmaceutical company focused on dermatological treatments, will participate in the 35th Annual ROTH Conference from March 12-14, 2023. CEO Claude Maraoui will host a fireside chat on March 14 at 9:30 a.m. PT and will be available for one-on-one meetings. A webcast of the chat will be accessible on Journey Medical's website for 30 days post-event. The company is committed to innovative dermatology products and currently markets eight treatments for common skin conditions. Founded by Fortress Biotech (Nasdaq: FBIO), Journey Medical is headquartered in Scottsdale, Arizona.
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.