Welcome to our dedicated page for Fortress Biotech news (Ticker: FBIOP), a resource for investors and traders seeking the latest updates and insights on Fortress Biotech stock.
Fortress Biotech, Inc. 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (FBIOP) is a preferred equity security of Fortress Biotech, Inc., a biopharmaceutical company whose activities are frequently covered in corporate news releases. While FBIOP itself is a preferred stock, its news flow is closely tied to Fortress Biotech’s broader business developments, regulatory milestones and financial results.
Company press releases describe Fortress Biotech as a biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income. News items regularly highlight progress across oncology, dermatology and rare disease programs, including FDA approvals, clinical trial updates and commercialization efforts.
Recent announcements include U.S. Food and Drug Administration approvals for products such as Emrosi and UNLOXCYT (cosibelimab-ipdl), as well as the approval of ZYCUBO (copper histidinate) for Menkes disease through majority-owned subsidiary Cyprium Therapeutics in collaboration with Sentynl Therapeutics. Fortress has also reported monetization events such as the acquisition of its subsidiary Checkpoint Therapeutics by Sun Pharma and the sale of dotinurad-related rights by subsidiary Urica Therapeutics to Crystalys Therapeutics, with equity and royalty components described in the releases.
Investors following FBIOP can use the news stream associated with Fortress Biotech to monitor developments that the company itself highlights as relevant to its portfolio and financial position, including quarterly financial results, asset sales, regulatory designations and partnerships with institutions such as AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital, Columbia University, Dana Farber Cancer Center and Sentynl Therapeutics. This news page aggregates such disclosures so readers can review the company’s own descriptions of its activities and portfolio evolution over time.
Fortress Biotech (Nasdaq: FBIO) and majority-owned Cyprium announced FDA approval of ZYCUBO® (copper histidinate) on January 13, 2026, as the first and only U.S. treatment for Menkes disease.
Key commercial terms: a Rare Pediatric Disease Priority Review Voucher will transfer to Cyprium, and Cyprium is eligible for tiered royalties plus up to $129 million in development and sales milestones from Sentynl. Clinical data showed a nearly 80% reduction in risk of death for early-treated patients and median overall survival of 177.1 months vs 17.6 months for the external control.
Fortress Biotech (Nasdaq: FBIO) and majority-owned Cyprium Therapeutics announced FDA acceptance of the CUTX-101 NDA resubmission as a Class 1 resubmission with a new PDUFA target action date of January 14, 2026. Sentynl Therapeutics resubmitted the NDA on November 14, 2025 after a September 30, 2025 complete response letter that cited observations about the manufacturing site's cGMP compliance but did not identify safety or efficacy deficiencies. Clinical topline data reportedly show significant improvement in overall survival for Menkes disease patients treated early. Under the Sentynl transaction, Sentynl will transfer a Rare Pediatric Disease PRV to Cyprium if approval is issued, and Cyprium is eligible for royalties plus up to $129 million in development and sales milestones.
Fortress Biotech (NASDAQ: FBIO) reported Q3 2025 total net revenue of $17.6M, a 20.5% increase versus Q3 2024, driven largely by Journey Medical dermatology sales. Journey Medical net product revenue was $17.0M in the quarter vs. $14.6M a year earlier. Fortress reported consolidated net income of $3.7M ($0.13 basic, $0.11 diluted) versus a loss of $(15.0)M in Q3 2024. Consolidated cash totaled $86.2M as of Sept 30, 2025, up $28.9M year-to-date. Corporate updates include Sun Pharma's acquisition of Checkpoint (Fortress received ~$28M upfront plus potential CVR and a 2.5% royalty), dotinurad entering two Phase 3 trials, and an FDA CRL for CUTX-101 citing manufacturing (cGMP) observations with a planned resubmission.
Fortress Biotech (NASDAQ: FBIO) subsidiary Urica Therapeutics announced that Crystalys Therapeutics dosed first patients in two global Phase 3 trials of dotinurad (RUBY NCT07089875; TOPAZ NCT07089888) on Oct 21, 2025. The studies compare once-daily oral URAT1 inhibitor dotinurad to physician-determined stable allopurinol in adults with gout and tophaceous gout.
Urica holds a minority equity stake in Crystalys and is eligible for a 3% royalty on future dotinurad sales. Fortress highlighted recent value events, including two U.S. FDA approvals (Emrosi and UNLOXCYT) and the Checkpoint Therapeutics sale that generated approximately $28M upfront.
Fortress Biotech (NASDAQ:FBIO) and its subsidiary Urica Therapeutics announced that Crystalys Therapeutics secured a $205 million Series A financing to advance global Phase 3 clinical trials for dotinurad, a next-generation URAT1 inhibitor for gout treatment.
Urica, which sold dotinurad to Crystalys in 2024, maintains an equity stake in Crystalys and will receive a 3% royalty on future dotinurad net sales. The drug has already received approval in Japan, China, Philippines, and Thailand. The financing round was co-led by Novo Holdings, SR One, and Catalys Pacific, with participation from multiple prominent investors.
Additionally, Fortress highlighted its recent achievement of selling subsidiary Checkpoint Therapeutics to Sun Pharma, receiving $28 million upfront plus potential CVR payments and royalties on UNLOXCYT™ sales.
Fortress Biotech (Nasdaq: FBIO) and its subsidiary Cyprium Therapeutics announced that the FDA has issued a Complete Response Letter (CRL) for CUTX-101, their drug candidate for treating Menkes disease in pediatric patients. The CRL cited cGMP deficiencies at the manufacturing facility but did not raise concerns about the drug's efficacy or safety data.
Sentynl Therapeutics, which assumed development and commercialization responsibilities in December 2023, plans to address the FDA's concerns and pursue resubmission. Upon approval, Cyprium remains eligible for a Rare Pediatric Disease Priority Review Voucher and could receive up to $129 million in development and sales milestones, plus royalties from Sentynl.
Fortress Biotech (Nasdaq: FBIO), a biopharmaceutical company focused on acquiring and advancing assets, announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference. CEO Lindsay A. Rosenwald will deliver a corporate overview presentation, which will be available for on-demand viewing by conference attendees starting September 5, 2025, at 7:00 a.m. ET.
The company will also participate in virtual one-on-one meetings during the conference, scheduled for September 8-11, 2025.
Fortress Biotech (NASDAQ:FBIO) reported significant Q2 2025 milestones and financial results. The company's subsidiary Checkpoint Therapeutics was acquired by Sun Pharma, generating ~$28 million upfront with potential for an additional $4.8 million CVR payment and 2.5% royalties on UNLOXCYT™ sales.
Key highlights include: FDA acceptance of CUTX-101's NDA with PDUFA date of September 30, 2025, commercial launch of Emrosi™ for rosacea treatment with expanded payer coverage reaching 65% of U.S. commercial lives, and consolidated net revenue of $16.4 million in Q2 2025. The company reported net income of $13.4 million ($0.50 per share basic).
Cash position strengthened to $74.4 million as of June 30, 2025, up from $57.3 million at end of 2024. Journey Medical's product revenues reached $15.0 million in Q2 2025.
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