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 reports developments tied to its biopharmaceutical portfolio, including product revenue, equity holdings, dividends and royalty interests across subsidiary and partner-company assets. Company updates include FDA approvals for assets such as ZYCUBO® for Menkes disease, Emrosi™ for rosacea and UNLOXCYT™ (cosibelimab-ipdl), along with clinical and regulatory updates for programs such as dotinurad for gout.
News for FBIOP also reflects events relevant to Fortress's 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock, including financial results, material agreements, subsidiary transactions, capital-structure matters and governance updates.
Fortress Biotech (Nasdaq: FBIO) reported 2025 results and material portfolio events. Key items: FDA approval of ZYCUBO® for Menkes disease, sale of a Rare Pediatric Disease PRV for $205 million by subsidiary Cyprium, and the May 2025 Checkpoint acquisition by Sun Pharma that generated ~$355 million upfront consideration to the seller group and a long‑term royalty stream.
Consolidated 2025 net revenue was $63.3M, R&D was $11.9M, SG&A was $96.4M, and net loss attributable to common stockholders was $1.9M (‑$0.07 per share).
Fortress Biotech (Nasdaq: FBIO) and majority-owned subsidiary Cyprium Therapeutics closed the sale of Cyprium’s Rare Pediatric Disease Priority Review Voucher for gross proceeds of $205 million on March 30, 2026. Fortress expects to receive over $100 million of the proceeds, improving liquidity for business development.
The PRV was issued after FDA approval of ZYCUBO on January 12, 2026. Cyprium remains eligible for tiered royalties on ZYCUBO sales and up to approximately $128 million in aggregate sales milestones from Sentynl. Cyprium must pay 20% of PRV proceeds to the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Fortress Biotech (Nasdaq: FBIO) subsidiary Cyprium Therapeutics entered a definitive agreement to sell a Rare Pediatric Disease Priority Review Voucher for $205 million in gross proceeds upon closing. The PRV was issued following FDA approval of ZYCUBO on January 12, 2026 and was transferred to Cyprium.
Cyprium remains eligible for tiered royalties on ZYCUBO net sales and up to $129 million in aggregate milestones from Sentynl; 20% of PRV sale proceeds are payable to the Eunice Kennedy Shriver NICHD. The deal is subject to customary closing conditions, including the HSR waiting period.
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.