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 (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.
Fortress Biotech (FBIO) celebrated its 10-year anniversary on the Nasdaq by ringing the closing bell on December 21, 2021. Chairman and CEO Lindsay A. Rosenwald highlighted the company's growth, boasting a 123% increase in net revenue year-over-year, totaling $21.1 million. Fortress has built a strong portfolio, including seven marketed pharmaceuticals and over 30 product candidates spanning oncology, gene therapy, and dermatology. Additionally, the company generated approximately $56.9 million from the sale of Caelum Biosciences to AstraZeneca, reinforcing its financial position.
Fortress Biotech announced the initiation of a Phase 2 clinical trial for Triplex, a cytomegalovirus (CMV) vaccine, targeting adults co-infected with HIV. Developed by City of Hope, the trial aims to assess the vaccine's safety and ability to elicit a CMV-specific immune response, potentially reducing CMV replication. A total of 90 participants will receive either the vaccine or a placebo over a 96-week study period. Previous studies show Triplex as safe and immunogenic, emphasizing its potential role in managing CMV-related complications in HIV patients.
Journey Medical (NASDAQ: DERM) reported net revenues of $19.6 million for Q3 2021, a 108% increase from $9.4 million in Q3 2020. The company completed its initial public offering, raising $31.2 million in net proceeds. Although the net loss for Q3 2021 was $10.6 million ($1.16 per share), this was an improvement compared to a net loss of $22.2 million ($2.43 per share) in Q3 2020. Journey Medical anticipates dosing the first patient in its Phase 3 clinical program for DFD-29 in Q1 2022 while expanding its leadership team.
Journey Medical Corporation (NASDAQ: DERM) announced its participation at the Benzinga Global Small Cap Conference, taking place virtually from December 8-9, 2021. CEO Claude Maraoui and CFO Ernie De Paolantonio will present a corporate overview on December 9 at 11:10 AM EST. They will also be available for one-on-one meetings during the conference. Journey Medical specializes in developing and commercializing products for dermatological conditions and was founded by Fortress Biotech (NASDAQ: FBIO).
Cyprium Therapeutics, a partner of Fortress Biotech (FBIO), has initiated a rolling submission of a New Drug Application (NDA) for CUTX-101 to the FDA for treating Menkes disease. The submission is expected to complete in mid-2022. Positive results from pivotal studies demonstrate CUTX-101's safety and efficacy, and the drug has received several FDA designations. If approved, CUTX-101 could be the first treatment for this rare disease, addressing a significant unmet need. Fortress stands to receive up to $20 million in milestones and continues to oversee CUTX-101's development.