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) 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.
Journey Medical Corporation (NASDAQ: DERM) has expanded its board of directors, admitting four new independent members: Jeffrey Paley, M.D., Justin Smith, Miranda Toledano, and Neil Herskowitz. This strategic move supports the company following its recent IPO. Executive Chairman Lindsay Rosenwald emphasized the new board members' extensive expertise in finance and dermatology, aiming to drive growth and commercialization of dermatological products. Journey Medical currently has seven marketed products and one in clinical development, indicating potential for future expansion.
Journey Medical Corporation (NASDAQ: DERM) has closed its initial public offering, successfully selling 3,520,000 shares at $10.00 each, raising gross proceeds of $35.2 million. The proceeds will be allocated towards general corporate purposes, including research and development, marketing, and potential acquisitions. The offering was managed by B. Riley Securities, with Roth Capital Partners as a co-manager. Journey Medical specializes in dermatological products and aims to leverage its capital for growth in the competitive pharmaceutical market.
Fortress Biotech (NASDAQ: FBIO) reported a remarkable 123% year-over-year increase in net revenue, reaching a record $21.1 million for Q3 2021. The company’s partner, Journey Medical Corporation, successfully launched its $35.2 million IPO. Fortress also received $56.9 million from AstraZeneca following its acquisition of Caelum Biosciences. Upcoming initiatives include a rolling NDA submission for CUTX-101 and top-line results for cosibelimab expected by year-end 2021. Operating expenses rose significantly, with R&D expenses totaling $28.1 million for the quarter.
Aegis Capital Corp. has successfully completed a $2.6 million public offering of common stock for Avenue Therapeutics (NASDAQ: ATXI). The funds raised through this offering are aimed at advancing Avenue's mission to develop IV tramadol, a potential alternative to conventional opioids for acute pain management in the U.S. Avenue Therapeutics was founded by Fortress Biotech (NASDAQ: FBIO) and is positioned to address the growing need for effective pain relief solutions.
Journey Medical Corporation (NASDAQ: DERM) has priced its initial public offering (IPO) at $10 per share, raising gross proceeds of $35.2 million. The company, a subsidiary of Fortress Biotech (NASDAQ: FBIO), will receive approximately $31.4 million in net proceeds after expenses. The IPO is set to close on November 16, 2021, with common stock starting to trade on November 12, 2021. Proceeds will support working capital, R&D, marketing, and potential acquisitions.