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 (FBIO) delivers innovative biopharmaceutical solutions through strategic acquisitions and subsidiary-driven development. This news hub provides investors and industry observers with centralized access to verified corporate updates across all therapeutic focus areas.
Track the latest press releases, regulatory milestones, and partnership announcements from Fortress Biotech and its network of specialized subsidiaries. Our curated feed includes updates on dermatology advancements, oncology research breakthroughs, and rare disease therapeutic developments. Stay informed about licensing agreements, clinical trial progress, and product commercialization efforts.
This resource serves as your primary source for FDA submissions, earnings reports, and strategic collaborations shaping FBIO's diversified pipeline. Bookmark this page for real-time updates on drug development progress and corporate initiatives that drive value across Fortress Biotech's unique operational ecosystem.
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.
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.
Journey Medical Corporation (NASDAQ:DERM), a commercial-stage pharmaceutical company focused on marketing FDA-approved dermatological treatments, has announced its participation in two upcoming investor conferences in September 2025.
CEO Claude Maraoui will attend the H.C. Wainwright 27th Annual Global Investment Conference on September 8, participating in a fireside chat and one-on-one meetings. Additionally, the company will participate in the Lake Street Capital Markets 9th Annual Best Ideas Growth Conference on September 11, featuring one-on-one meetings with investors.
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.
Journey Medical Corporation (NASDAQ:DERM), a commercial-stage pharmaceutical company focused on FDA-approved dermatological treatments, announced its upcoming presentation at the Emerging Growth Conference. Claude Maraoui, Co-Founder, President and CEO, will deliver a corporate overview on August 20, 2025, at 12:35 p.m. ET.
The presentation will be conducted virtually through video webcasts. Investors can access the live event by registering at emerginggrowth.com/conference, and an archived version will be available on EmergingGrowth.com and the Emerging Growth YouTube Channel.
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.
Journey Medical Corporation (NASDAQ:DERM) reported Q2 2025 financial results with total revenues of $15.0 million, including $2.8 million from Emrosi™ in its first full quarter of sales. The company achieved a 67% gross margin, up from 61% in the prior year quarter, despite reporting a net loss of $3.8 million or $(0.16) per share.
Key highlights include Emrosi's expanded payer access covering over 100 million commercial lives in the U.S., up from 54 million in May 2025. The company joined the Russell 2000® and Russell 3000® Indexes in June 2025. Journey Medical maintained its cash position at $20.3 million as of June 30, 2025, and appointed Ramsey Alloush as Chief Operating Officer.
Journey Medical Corporation (NASDAQ:DERM) announced that its management team will ring the Nasdaq MarketSite closing bell on August 11, 2025, celebrating its 4-year anniversary as a public company and the commercial launch of Emrosi™, their new rosacea treatment.
CEO Claude Maraoui highlighted the company's consistent execution of its commercial strategy, led by their experienced management and specialized dermatology sales force. The company expects positive EBITDA later in 2025, citing strong initial revenue from Emrosi, improving margins, and a solid cash position.