On August 13, 2026 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, reported financial results and recent corporate highlights for the second quarter ended June 30, 2026.
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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "The second quarter of 2026 reflected continued momentum across our portfolio and further progress in unlocking long-term shareholder value. Our subsidiary Urica Therapeutics, Inc.’s ("Urica") equity position in Crystalys Therapeutics, Inc. ("Crystalys") was strengthened by Crystalys’ $130 million Series B financing, which will support the late-stage global development and commercialization preparation for dotinurad, a next-generation oral URAT1 inhibitor for gout, on which Urica is entitled to a 3% royalty on future net sales. Journey Medical also continues to scale Emrosi, securing a third major GPO contract that expanded payer access to over 150 million commercial lives. Coming off the momentum of ZYCUBO’s approval and the $205 million PRV sale in the first quarter, we enter the second half of 2026 with a favorable cash balance that positions us to continue executing on our pipeline and business development priorities."
Dr. Rosenwald added, "We continued to see encouraging clinical progress this quarter on our partnered programs. AstraZeneca reported additional prespecified subgroup analyses for anselamimab (formerly CAEL-101) showing a 62% improvement in survival and a 71% reduction in cardiovascular hospitalizations among kappa predominant light chain isotype patients in the CARES program, and indicated that it plans to submit these findings to regulatory authorities. Crystalys also continues to advance dotinurad’s two global Phase 3 trials while initiating a new Phase 2 study in difficult-to-treat gout, broadening the program’s potential patient population. With a diversified portfolio spanning commercial, late-stage, and development-stage programs, including royalties, milestones and equity, and a strengthened balance sheet following the ZYCUBO PRV monetization, we believe Fortress is well positioned to advance strategic initiatives and drive long-term value for our shareholders."
Recent Corporate Highlights1:
Commercial Portfolio Updates
● Journey Medical Expands Payer Access for Emrosi. At the end of March 2025, our partner company Journey Medical Corporation ("Journey Medical") commercially launched Emrosi (40mg Minocycline Hydrochloride Modified-Release Capsules, consisting of 10mg immediate release and 30mg extended release pellets), also known as DFD-29, for inflammatory lesions of rosacea. Emrosi was approved by the FDA in November 2024 and is available by prescription at specialty pharmacy chains. In April 2026, Journey Medical announced that it secured a contract with a third major group purchasing organization (GPO) for Emrosi. As such, payer access for Emrosi expanded to over 150 million commercial lives as of April 1, 2026, which equates to approximately 85% of all commercial lives in the United States that have access to Emrosi. Journey Medical reported net product revenues of $17.8 million for the second quarter of 2026, compared to net product revenues of $15.0 million for the second quarter ended June 30, 2025.
● Royalties. In the second quarter of 2026, Cyprium Therapeutics, Inc. ("Cyprium") recognized $0.2 million in royalty revenue on net sales of ZYCUBO, and Fortress recognized $0.1 million in royalty income (contingent consideration) on net sales of UNLOXCYT, following their recent commercial launches.
Clinical Updates
● Phase 3 CARES Results for Anselamimab (CAEL-101); Regulatory Submission of Prespecified Subgroup Analysis Planned. In the second quarter of 2026, AstraZeneca announced additional prespecified subgroup analyses in patients with kappa predominant light chain isotype, showing that anselamimab (formerly known as CAEL-101) improved survival by 62%, measured by time to all-cause mortality (HR 0.38; 95% CI 0.17, 0.86; nominal p=0.012), and reduced the frequency of cardiovascular hospitalizations by 71% (incidence risk ratio 0.29; 95% CI 0.10, 0.87; nominal p=0.028) compared to placebo in the subgroup with kappa AL amyloidosis. Although anselamimab did not achieve statistical significance for the primary endpoint in its Phase III Cardiac Amyloid Reaching for Extended Survival ("CARES") clinical program for Mayo stages IIIa and IIIb AL amyloidosis patients, the drug showed clinically meaningful improvement in the prespecified subgroup and was well tolerated. AstraZeneca indicated that the company plans to submit the prespecified subgroup analysis from the CARES trials to regulatory authorities and disclosed regulatory submissions in the EU and Japan.
● Dotinurad Progresses in Phase 3 Development with Crystalys Series B Financing of $130 million; Initiation of Phase 2 Clinical Trial for Difficult-to-Treat Gout. In July 2026, Crystalys, in which our majority-owned and controlled subsidiary company Urica maintains an equity position, announced a $130 million Series B financing to support the late-stage global clinical development and commercialization preparation for dotinurad. Patients continue to be enrolled in Crystalys’ two randomized, double-blind, multicenter global Phase 3 trials evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout. In the second quarter of 2026, Crystalys also announced the initiation of a Phase 2 study in difficult-to-treat gout.
● Other Portfolio Programs Continue to Advance with Potential Upcoming Data and Trial Initiations. Triplex is currently in multiple ongoing clinical trials for cytomegalovirus (CMV) treatment and prevention in solid organ and stem cell transplants, combination trials with CAR T cell therapies for hematologic malignancies, and a potential data readout by the end of 2026 for prevention and control of CMV in patients co-infected with HIV and CMV. A clinical trial evaluating MB-109, a combination CAR T cell therapy and oncolytic virus, is anticipated to initiate in the fourth quarter of 2026 for patients with IL13Rα2-positive recurrent glioblastoma and high-grade astrocytoma. There are also ongoing and planned regulatory interactions with the FDA on trial designs for ATX-04 (selective β2-adrenergic agonist) for patients with Pompe disease and FB-606 (membrane stabilizer) for patients with Duchenne muscular dystrophy.
Financial Results:
● As of June 30, 2026, Fortress’ consolidated cash and cash equivalents totaled $196.6 million, compared to $79.4 million as of December 31, 2025, an increase of $117.2 million year-to-date.
● Fortress’ consolidated cash and cash equivalents totaling $196.6 million as of June 30, 2026, includes $153.8 million attributable to Fortress and the private subsidiaries, $1.9 million attributable to Avenue, $15.1 million attributable to Mustang Bio and $25.6 million attributable to Journey Medical.
o Fortress’ consolidated cash and cash equivalents totaled $79.4 million as of December 31, 2025, and includes $35.2 million attributable to Fortress and private subsidiaries, $2.9 million attributable to Avenue, $17.3 million attributable to Mustang and $24.1 million attributable to Journey Medical.
● Fortress’ consolidated net revenue totaled $18.7 million for the second quarter ended June 30, 2026, $17.8 million of which was generated from our marketed dermatology products. This compares to consolidated net revenue totaling $16.4 million for the second quarter of 2025, $15.0 million of which was generated from our marketed dermatology products.
● Consolidated research and development expenses totaled $0.8 million for the second quarter ended June 30, 2026, compared to $8.1 million for the second quarter ended June 30, 2025.
● Consolidated selling, general and administrative costs were $20.8 million for the second quarter ended June 30, 2026, compared to $38.8 million for the second quarter ended June 30, 2025.
● Consolidated net loss attributable to common stockholders was $(2.5) million, or $(0.08) per share basic and diluted, for the second quarter ended June 30, 2026, compared to net income attributable to common stockholders of $13.4 million, or $0.50 per share basic, and $0.45 per share diluted, for the second quarter ended June 30, 2025.
(Press release, Fortress Biotech, AUG 13, 2026, View Source [SID1234670065])