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.
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Fortress Biotech subsidiary, Aevitas Therapeutics, has entered into an asset purchase agreement with 4D Molecular Therapeutics (4DMT) for Aevitas' short-form human complement factor H (sCFH) asset, targeting complement-mediated diseases. The agreement could yield up to $140 million in milestone payments and royalties for Aevitas. 4DMT plans to develop product candidate 4D-175 to treat Geographic Atrophy (GA) linked to age-related macular degeneration (AMD). This innovative therapy combines Aevitas' sCFH with 4DMT's proprietary vector, enhancing treatment efficacy. Fortress' CEO, Lindsay A. Rosenwald, emphasized the partnership’s potential to generate shareholder value by expediting the development of this promising therapy. The technology aims to restore normal complement regulation and reduce retinal injury.
Fortress Biotech, Inc. (Nasdaq: FBIO) reported consolidated net revenues of $75.7 million for the full-year 2022, a significant growth from $68.8 million in 2021. The company is gearing up to file three new drug applications in 2023, including the Biologics License Application for cosibelimab for cSCC and NDA submissions for CUTX-101 and DFD-29. Cosibelimab's FDA filing was accepted with a PDUFA date set for January 3, 2024. The company aims to enhance its clinical pipeline and diversify with new acquisitions while maintaining a strong growth trajectory amidst escalating R&D expenditures.
Journey Medical Corporation (Nasdaq: DERM) reported total revenues of $73.7 million for the full year 2022, reflecting a 17% increase from 2021. The company experienced a 9% decline in Q4 revenue, primarily due to generic competition affecting Targadox. Despite this, SG&A expenses increased due to expanded sales efforts, reaching $59.5 million. The net loss decreased to $29.6 million, or $1.69 per share from $44.0 million in 2021. Journey Medical completed enrollment for its Phase 3 clinical trials for DFD-29 in January 2023, with topline data expected soon. The company plans to file a New Drug Application in the second half of 2023.