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 (FBIO) reported its Q1 2021 financial results, ending with $291.5 million in cash. The company launched two new dermatology products, raising its total to seven. Revenue from marketed products was $10.7 million, a decline from $11.9 million in Q1 2020 due to increased coupon costs. The company is on track for a rolling NDA submission for CUTX-101 for Menkes disease in H2 2021 and expects key data from clinical trials by year-end. The net loss attributable to common stockholders was $8.8 million or $0.11 per share, improved from a loss of $12.4 million in the previous year.
Fortress Biotech has signed an exclusive agreement with Fuji Yakuhin to develop Dotinurad, a URAT1 inhibitor for gout and other hyperuricemic conditions, in North America and Europe. Approved in Japan in 2020, Dotinurad demonstrated efficacy and safety in Phase 3 trials involving over 500 patients. The partnership allows Fortress to leverage data from these trials while Fuji stands to gain from milestone and royalty payments. With nearly 20 million gout patients across the targeted regions, this collaboration presents substantial market potential.
Fortress Biotech (NASDAQ: FBIO) announced that CEO Lindsay A. Rosenwald will participate in the 20th Annual Needham Virtual Healthcare Conference from April 12-15, 2021. Fortress will present on April 12 at 4:30 p.m. ET, and one-on-one meetings will also be held. The presentation will be available via a webcast on the company's website for about 30 days.
Fortress focuses on developing and commercializing promising biopharmaceutical products, boasting seven marketed drugs and over 25 in development.
Journey Medical Corporation, a partner of Fortress Biotech (NASDAQ: FBIO), has secured a $7.5 million working capital line of credit from East West Bank. The credit line, backed by Journey Medical's receivables and cash, carries an interest rate of 4.25% or the Prime Rate plus 1%, and is set to expire in 36 months. The funds will be used for general corporate purposes and to advance the company's portfolio in dermatology products. Journey Medical aims to enhance its market position by acquiring additional dermatology products and commercializing its existing offerings.
Journey Medical Corporation, a partner of Fortress Biotech (NASDAQ: FBIO), has announced its definitive agreement to acquire QBREXZA from Dermira, a subsidiary of Eli Lilly. This prescription cloth towelette is the first approved treatment for primary axillary hyperhidrosis for patients aged nine and older. The acquisition is expected to close in early Q2 2021, with QBREXZA generating $24 million in net sales in 2020. The product is recognized as a first-line treatment by the International Hyperhidrosis Society and aims to help approximately 10 million Americans suffering from excessive sweating.
Fortress Biotech reported a 28% increase in revenue from its marketed dermatology products for 2020, totaling $44.5 million. The company is on track for a rolling NDA submission for CUTX-101 for Menkes disease in H2 2021, following a partnership agreement with Cyprium Therapeutics. Despite revenue growth, sales were affected by the COVID-19 pandemic. Fortress holds a strong pipeline with over 25 product candidates and expects further growth in 2021. However, ongoing monitoring of COVID-19's impact on revenues is essential.
Fortress Biotech announced the launch of Accutane®, an oral isotretinoin for severe recalcitrant nodular acne, by its partner Journey Medical Corporation. Available via prescription, Accutane joins Journey Medical's portfolio, which includes Targadox® and Ximino®. With over 1.8 million isotretinoin prescriptions written in 2020, the brand aims to utilize its established name and sales team for growth. Fortress CEO highlights the strategic acquisition of transformative assets, projecting significant revenue potential for this product.
Fortress Biotech, Inc. (NASDAQ: FBIO) has announced that its CEO, Lindsay A. Rosenwald, M.D., will participate in four virtual investor conferences throughout March 2021. Key presentations include:
- H.C. Wainwright Global Life Sciences Virtual Conference on March 9.
- Barclays Global Healthcare Virtual Conference on March 11.
- ROTH Conference on March 16.
- Oppenheimer Virtual Healthcare Conference on March 18.
Fortress focuses on developing and commercializing biopharmaceutical products across multiple market areas, enhancing shareholder value.
Fortress Biotech (NASDAQ: FBIO) supports Rare Disease Day on February 28, aiming to raise awareness for over 25 million Americans affected by rare diseases. The company, led by CEO Lindsay A. Rosenwald, has ongoing clinical programs for conditions like AL amyloidosis and X-linked severe combined immunodeficiency (XSCID). Notably, the Menkes disease NDA submission is planned for Q3 2021. Additionally, Fortress is engaged in related campaigns such as 'Light the Night for Amyloidosis.' Rare Disease Day emphasizes the challenges of patients, as many rare diseases lack FDA-approved treatments.
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.