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) 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.
Journey Medical (Nasdaq: DERM) reported full-year 2025 results and corporate highlights on March 25, 2026. Total revenues were $61.9 million, up 10% from $56.1 million in 2024, driven by the commercial launch of Emrosi™ (net revenues $14.7 million; ~53,000 prescriptions).
Gross margin improved to 66.2%, Adjusted EBITDA was $2.9 million, cash was approximately $24.1 million, and working capital was $29.4 million. Net loss narrowed to $11.4 million (−$0.47/share).
Journey Medical (Nasdaq: DERM) will release its year-end 2025 financial results after market close on March 25, 2026.
The company will host a conference call and live audio webcast the same day at 4:30 p.m. ET; registration is available online and the replay will remain available about 30 days.
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.
Journey Medical (Nasdaq: DERM) reported publication (Dec 10, 2025) of Phase 1 results for Emrosi (DFD-29) in the Journal of Drugs in Dermatology.
The multicenter, randomized, double-blind study enrolled 60 healthy adults (2:1 DFD-29:placebo), dosing once daily for 16 weeks. The trial met all three primary microbiological endpoints: no significant change in skin, GI, or vaginal microbiota; no detectable minocycline resistance; and no emergence of opportunistic organisms. No significant safety issues were reported. Emrosi (40 mg minocycline modified-release: 10 mg immediate + 30 mg extended) is FDA-approved in the U.S. for inflammatory rosacea lesions in adults.
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.
Journey Medical (Nasdaq: DERM) reported Q3 2025 net revenues of $17.6 million, a 21% year-over-year increase driven by the U.S. commercial launch of Emrosi. Emrosi generated $4.9 million in net sales and prescriptions rose 146% sequentially versus Q2 2025. Gross margin improved sequentially in 2025 to 67.4% in Q3. Net loss narrowed to $2.3 million (or $(0.09) per share). Adjusted EBITDA was positive $1.7 million. Cash and cash equivalents totaled $24.9 million at September 30, 2025. Management hosted a conference call on November 12, 2025 to discuss results and recent clinical and commercial highlights.