Fortress Biotech, Inc. (“Fortress” or the “Company”) is a biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holding and dividend and royalty revenue streams. Fortress works in concert with our extensive network of key opinion leaders to identify and evaluate promising products and product candidates for potential acquisition.
Estimated readout windows: registry primary-completion date + 6-12 weeks. Windows already open are shown from "Now". Drug names link to ClinicalTrials.gov.
Partnerships Sentynl Therapeutics: Rare Pediatric Disease PRV transferred to Cyprium per transaction; PRV sold for $205 million (closed March 30, 2026)
Indications
Menkes disease (pediatric patients)(Approved)
Status note FDA approved January 13, 2026 (Cyprium Therapeutics, a Fortress subsidiary); Rare Pediatric Disease PRV issued and monetized for $205M.
anselamimab
Phase 3 · ActiveModality: monoclonal antibody
Aliases CAEL-101
Target amyloid light chain fibrils
Partnerships AstraZeneca (successor-in-interest to Alexion): strategic partnership; July 16, 2025 update — CARES primary endpoint not met (not statistically significant vs placebo); subgroup showed improvement in time to ACM/CVH; regulatory applications under review in Japan and by the EMA
Indications
AL amyloidosis, Mayo Stage IIIa and IIIb(Phase 3)
Status note Two ongoing global Phase 3 CARES studies (NCT04512235, NCT04504825). Phase 3 missed its primary endpoint (hierarchical combination of time to all-cause mortality and CV hospitalization frequency) per AstraZeneca, July 2025; program continues with applications under review in Japan and EMA.
dotinurad
Phase 2 · Active
Target URAT1
Partnerships Crystalys (via Fortress subsidiary Urica Therapeutics): closed $205M Series A (Oct 2025) to advance global Phase 3 gout studies
Indications
Gout (intolerant to xanthine oxidase inhibitors or failed uricase)(Phase 2)
Status note First patients dosed May 2026 in randomized, double-blind, placebo-controlled Phase 2 AMETHYST study (NCT07535034).
ATX-04
Preclinical · ActiveModality: small molecule (selective beta-2-adrenergic agonist)
Status note Avenue Therapeutics (Fortress partner company). Pre-technological-feasibility; license costs charged to R&D.
Per-asset detail extracted from the 10-Q filed 2026-08-13. Fields the filing does not state are marked "not disclosed" rather than filled from other sources.
No lead program on file for this company.
No active ClinicalTrials.gov trials matched to this company as sponsor or collaborator.
Specialist fund holders
Tracked specialist funds: ADAR1 Capital Management, Aisling Capital, Ally Bridge Group, Avoro Capital Advisors, BVF Partners, Baker Bros. Advisors, Boxer Capital, Braidwell LP, Casdin Capital, Cormorant Asset Management, DAFNA Capital, Deerfield Management, EcoR1 Capital, Frazier Life Sciences, Great Point Partners, Ikarian Capital, Logos Global Management, OrbiMed Advisors, Perceptive Advisors, RA Capital Management, RTW Investments, Sphera Biotech, Stonepine Capital, Tang Capital Partners, Vivo Capital.
None of the tracked specialist funds reported a position in the latest 13F snapshot.
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