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.
Cyprium Therapeutics, a subsidiary of Fortress Biotech (FBIO), is progressing with CUTX-101 for Menkes disease, aiming for the first FDA approval. Positive data will be presented at the ACMG Annual Clinical Genetics Meeting. The rolling submission of the New Drug Application (NDA) is expected to complete mid-2022. CUTX-101 has shown efficacy in pivotal studies, significantly improving survival rates for early-treated patients. The partnership with Sentynl Therapeutics focuses on market introduction and newborn screening initiatives. Menkes disease, caused by ATP7A mutations, has a high mortality rate in untreated cases.
Journey Medical Corporation (NASDAQ: DERM) plans to release its year-end 2021 financial results on March 23, 2022, following the U.S. market close. A conference call to discuss these results will take place on the same day at 4:30 p.m. ET. Interested individuals can participate by dialing the provided numbers or joining the live audio webcast available on the company’s website. Journey Medical focuses on the development and commercialization of dermatological products and has nine products currently in the market.
Journey Medical Corporation announced the initiation of a Phase 3 clinical trial for DFD-29 (Minocycline Modified Release Capsules) to treat papulopustular rosacea. This follows promising Phase 2 data showing DFD-29 had approximately double the efficacy of Doxycycline capsules in reducing inflammatory lesions. The trial includes two multicenter, randomized studies, each enrolling up to 320 adult patients. The primary objective is to evaluate DFD-29's safety and effectiveness compared to placebo and Doxycycline over 16 weeks. Claimed benefits could significantly enhance treatment options for the estimated 415 million global rosacea sufferers.
Fortress Biotech (NASDAQ: FBIO) announced that its Chairman and CEO, Lindsay A. Rosenwald, M.D., will participate in three key investor conferences in March 2022. These conferences include:
- 34th Annual ROTH Conference: Fireside chat on March 14, 2022, at 3:00 p.m. PT.
- Oppenheimer’s 32nd Annual Virtual Healthcare Conference: Presentation on March 16, 2022, at 8:40 a.m. ET.
- Cantor Fitzgerald’s Rare Orphan Disease Summit: Panel on March 30, 2022, at 8:30 a.m. ET.
Webcasts of the sessions will be available on Fortress Biotech's website for approximately 30 days.
Journey Medical Corporation (NASDAQ: DERM) announced its participation in the 34th Annual ROTH Conference from March 13-15, 2022. CEO Claude Maraoui will present a corporate overview on March 14 at 12:00 p.m. PT, with one-on-one meetings available throughout the event. A webcast of the presentation will be accessible on Journey Medical's website for about 30 days post-conference. Journey Medical focuses on developing dermatological products, currently marketing nine solutions aimed at treating common skin conditions.
Fortress Biotech (NASDAQ: FBIO) announced a virtual summit hosted by B. Riley Securities on April 5-6, 2022, showcasing its diverse pipeline. The event aims to highlight various programs within Fortress' portfolio of over 30 development-stage projects across multiple therapeutic areas, including oncology and rare diseases. Registration details will be available shortly before the summit, and the webcasts will be accessible on Fortress' investor webpage for 30 days post-event.
Journey Medical Corporation (NASDAQ: DERM) announced that its licensing partner, Maruho Co., Ltd., received approval from Japan's Ministry of Health for Rapifort® Wipes 2.5%, used for treating primary axillary hyperhidrosis. This milestone triggers a $10 million payment, with Journey receiving $2.5 million. The approval expands Journey's revenue beyond U.S. sales. Rapifort® Wipes is a derivative of QBREXZA, which is FDA-approved for similar use in the U.S. and recognized by the International Hyperhidrosis Society as a first-line treatment.
Fortress Biotech, Inc. (NASDAQ: FBIO) will present a corporate update at the 2nd Annual Winter Wonderland Best Ideas Virtual Investor Conference on February 9, 2022, at 9:30 a.m. ET. Lindsay A. Rosenwald, M.D., the Chairman, President, and CEO, will also engage in one-on-one meetings during the conference. A live webcast of the presentation will be available on Fortress's website for approximately 30 days post-event. Fortress Biotech focuses on acquiring, developing, and commercializing pharmaceutical products, with a diverse pipeline that includes over 30 development programs in areas like oncology and gene therapy.
Journey Medical (NASDAQ: DERM) has announced the acquisition of VYNE Therapeutics' Molecule Stabilizing Technology franchise for $20 million upfront, plus an additional $5 million after one year, with further milestone payments of up to $450 million based on net sales achievements. This acquisition includes the FDA-approved products AMZEEQ® for acne and ZILXI® for rosacea, and expands Journey Medical's dermatology portfolio to nine products. Additionally, the company increased its credit agreement with East West Bank to $30 million to support growth.
Fortress Biotech (NASDAQ: FBIO) announced that Dr. Lindsay A. Rosenwald, Chairman and CEO, will present at the H.C. Wainwright BioConnect Virtual Conference from January 10 to January 13, 2022. The presentation will be available for on-demand viewing on Fortress’ website starting January 10, 2022, at 7:00 a.m. EST, for 30 days. Fortress Biotech focuses on developing and commercializing biopharmaceutical products, with a diverse pipeline that includes seven marketed products and over 30 in development across oncology, rare diseases, and gene therapy.