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.
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.
Fortress Biotech, Inc. (NASDAQ: FBIO) announced that its CEO, Lindsay A. Rosenwald, M.D., will participate in three virtual investor conferences this September. The events include:
- H.C. Wainwright 22nd Annual Global Investment Conference on September 14 at 3:00 p.m. EDT
- Cantor Virtual Global Healthcare Conference on September 16 at 3:20 p.m. EDT
- Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22 at 1:40 p.m. EDT
Live webcasts will be available on Fortress's website, with archived versions accessible for 30 days post-event.
Fortress Biotech (Nasdaq: FBIO) announced positive results for CUTX-101, showing a statistically significant improvement in overall survival for patients with Menkes disease who received early treatment. The treatment demonstrated a nearly 80% reduction in the risk of death (Hazard Ratio = 0.21). Median survival for the treated cohort was 14.8 years versus 1.3 years for those untreated. The company plans to begin a rolling New Drug Application (NDA) submission to the FDA in Q4 2020, following its pre-NDA meeting. CUTX-101 has received multiple FDA designations, indicating its importance in treating this rare disease.
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.