Rare Disease Research

Stockholm – November 03, 2026 -- Sobi (STO: SOBI) will present six abstracts on two late-stage gout assets, pozdeutinurad (AR882) and nanoencapsulated sirolimus plus pegadricase (NASP), at ACR Convergence 2026, the American College of Rheumatology annual meeting, in Orlando, Florida, on 6–11 November 2026.

Phase 3 REDUCE-2 results for pozdeutinurad headline the program

The presentations include results from the Phase 3 REDUCE-2 study of pozdeutinurad, an investigational once-daily oral, highly selective URAT1 inhibitor for uncontrolled gout. REDUCE-2 is one of two 12-month, randomised, double-blind, placebo-controlled Phase 3 studies, alongside REDUCE-1, that are evaluating the drug in more than 800 patients. Both trials assess its ability to lower serum urate (SU) in patients with uncontrolled gout.

Earlier Phase 2 studies showed a sustained SU reduction, dissolution of tophi and a generally well-tolerated safety profile, according to Sobi.

Valby, Denmark – – September 17, 2026 -- The U.S. Food and Drug Administration has granted Orphan Drug Designation to asedebart (Lu AG13909), Lundbeck's investigational anti-ACTH monoclonal antibody, for the treatment of endogenous Cushing's syndrome.

FDA designation adds U.S. market exclusivity potential for Lundbeck's rare disease pipeline

The designation covers drugs and biologics intended for rare diseases and can provide tax credits for qualified clinical testing, exemption from certain FDA application fees, and up to seven years of market exclusivity if the drug is approved for the designated indication.