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 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.
Journey Medical Corporation (NASDAQ:DERM), a commercial-stage pharmaceutical company focused on FDA-approved dermatological treatments, has scheduled its second quarter 2025 financial results announcement for August 12, 2025, after market close.
The company will host a conference call and audio webcast at 4:30 p.m. ET on the same day. U.S. participants can dial 1-866-777-2509, while international callers should use 1-412-317-5413. The webcast will be available on Journey Medical's website for approximately 30 days following the call.
Journey Medical Corporation (NASDAQ:DERM) announced significant expansion in commercial payer coverage for Emrosi™, its FDA-approved treatment for inflammatory rosacea lesions in adults. The coverage has increased to 65% of commercial lives (187 million) in the United States, up substantially from 29% in May 2025.
The expanded coverage is attributed to Journey Medical's targeted contracting strategy, increasing prescription demand, and strong clinical data showing Emrosi's superior efficacy over current standard treatments. The medication is available through specialty pharmacy chains, with the company positioning it to become the standard of care for rosacea treatment.