Fortress Biotech reports Q2 2026 results as partnered pipeline advances on multiple fronts
Crystalys raised $130 million for dotinurad's Phase 3 program while AstraZeneca reported positive subgroup data for anselamimab, as Fortress's cash balance grew to $196.6 million.
Fortress Biotech disclosed second quarter 2026 results and pipeline updates on August 13, 2026, tied to its June 30, 2026 quarter close.
On the clinical side, 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.1 The drug did not achieve statistical significance for the primary endpoint in the Phase III CARES program for Mayo stages IIIa and IIIb AL amyloidosis patients, though the company described the subgroup result as clinically meaningful and said the drug was well tolerated.1 AstraZeneca said it plans to submit the prespecified subgroup analysis to regulatory authorities and disclosed regulatory submissions already made in the EU and Japan.1
In gout, Crystalys, in which Fortress subsidiary Urica holds an equity stake, announced in July 2026 a $130 million Series B financing to support late-stage global development and commercialization preparation for dotinurad.1 Patients continue to be enrolled in two randomized, double-blind, multicenter global Phase 3 trials for dotinurad, a once-daily oral URAT1 inhibitor for gout.1 Crystalys also announced initiation of a Phase 2 study in difficult-to-treat gout during the quarter.1
Other pipeline items: Triplex remains in multiple ongoing trials for CMV treatment and prevention and combination work with CAR T therapies, with a potential data readout expected by the end of 2026 for HIV/CMV co-infected patients.1 A trial of MB-109, combining CAR T cell therapy with an oncolytic virus, is expected to begin in the fourth quarter of 2026 for IL13Rα2-positive recurrent glioblastoma and high-grade astrocytoma.1 Regulatory interactions with the FDA continue on trial designs for ATX-04 in Pompe disease and FB-606 in Duchenne muscular dystrophy.1
On finances, consolidated cash and cash equivalents totaled $196.6 million as of June 30, 2026, up from $79.4 million at year-end 2025, an increase of $117.2 million.1 Net revenue was $18.7 million for the quarter, versus $16.4 million a year earlier, with $17.8 million derived from marketed dermatology products this quarter compared to $15.0 million last year.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.