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) 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.
Journey Medical (Nasdaq: DERM) will release third quarter 2025 financial results after U.S. markets close on Wednesday, November 12, 2025. Management will host a conference call and live audio webcast the same day at 4:30 p.m. ET to discuss results and provide a corporate update.
Domestic dial-in is 1-866-777-2509, international dial-in is 1-412-317-5413. Participants may register at the provided registration link and a live webcast will be available on the Investors > News and Events page with replay accessible for approximately 30 days.
Journey Medical (Nasdaq: DERM) presented pooled Phase 3 efficacy data for Emrosi (DFD-29) at the 2025 Fall Clinical Dermatology Conference on October 24, 2025. The pooled analysis of MVOR-1 and MVOR-2 included 653 subjects randomized 3:3:2 and compared once-daily DFD-29, Oracea (doxycycline 40 mg) and placebo over 16 weeks.
Key results: IGA success 62.7% for DFD-29 vs 39.0% for Oracea and 28.2% for placebo (P<0.001 each). Mean inflammatory lesion change at week 16: -19.2 for DFD-29 vs -14.8 Oracea and -11.3 placebo (P<0.001 each). The company reported no major safety issues or serious adverse events related to study drug.
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.
Journey Medical (Nasdaq: DERM) said its management team will participate in two investor conferences in October 2025 in New York City.
Events and formats:
- ROTH Healthcare Opportunities Conference — Thursday, October 9, 2025 — 1x1 meetings.
- The ThinkEquity Conference — Thursday, October 30, 2025 — presentation and 1x1 meetings.
The company will engage investors through one-on-one meetings and a public presentation on the listed dates.
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.
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