Fortress Biotech Inc Stock Price, News & Analysis

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.

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.

Fortress Biotech (NASDAQ: FBIO) has completed the sale of its subsidiary Checkpoint Therapeutics to Sun Pharmaceutical Industries Limited. The transaction, which closed on May 30, 2025, will provide Fortress with approximately $28 million in immediate proceeds, plus potential additional benefits including a contingent value right (CVR) of up to $4.8 million and a 2.5% royalty on future net sales of UNLOXCYT. The deal values Checkpoint shares at $4.10 per share in cash, with stockholders eligible for an additional $0.70 per share through the CVR if UNLOXCYT receives approval in key European markets. UNLOXCYT, approved by the FDA in December 2024, is the first FDA-approved PD-L1 blocking antibody for advanced cutaneous squamous cell carcinoma. Fortress is now focusing on other initiatives, including their subsidiary Cyprium Therapeutics' CUTX-101 with a PDUFA date of September 30, 2025.

Fortress Biotech (FBIO) reported Q1 2025 financial results and corporate highlights. Key developments include: Emrosi™ commercial launch for rosacea treatment, pending acquisition of subsidiary Checkpoint Therapeutics by Sun Pharma (~$28M expected at closing), and FDA's acceptance of CUTX-101's New Drug Application for priority review with PDUFA date of September 30, 2025. Q1 financials show consolidated cash of $91.3M (up from $57.3M in Q4 2024), net product revenue of $13.1M, and net loss of $(12.7M) or $(0.48) per share. R&D expenses decreased to $3.9M from $24.8M year-over-year, while SG&A costs increased to $25.7M from $17.9M. The company's pipeline includes multiple late-stage programs and newly approved products, positioning it for continued growth and potential monetization opportunities.

Fortress Biotech (NASDAQ: FBIO), a biopharmaceutical company focused on acquiring and advancing assets for shareholder value through product revenue, equity holdings and dividend and royalty revenue, has announced its participation in the H.C. Wainwright 1st Annual Royalty Company Virtual Conference on May 13, 2025.

The company's CEO, Lindsay A. Rosenwald, M.D., will participate in two sessions: a Fireside Chat from 2:00 PM to 2:30 PM ET, and a Panel Presentation titled "Development Stage Companies – Where Do Royalty and Tech Platform Plays Fit?" from 5:00 PM to 6:00 PM ET.

Fortress Biotech (FBIO) reported significant developments for 2024, including two FDA approvals: Emrosi™ for rosacea treatment and UNLOXCYT™ for advanced skin cancer. The company's subsidiary Checkpoint Therapeutics is being acquired by Sun Pharma, expected to bring Fortress approximately $28 million at closing plus a 2.5% royalty on UNLOXCYT sales.

Key financial metrics for 2024 include consolidated net revenue of $57.7 million, down from $84.5 million in 2023. The company reported a net loss of $(55.9) million or $(2.69) per share, improved from $(68.7) million in 2023. Cash position stood at $57.3 million as of December 31, 2024.

Notable developments include FDA's acceptance of CUTX-101's New Drug Application for Menkes disease with a PDUFA date of September 30, 2025, and the commercial launch of Emrosi with first prescriptions filled.