• The Phase 2b LUMA study of BIIB122 in early-stage Parkinson's disease did not meet its primary or secondary endpoints 
• Based on data from the Phase 2b LUMA study, Biogen and Denali will discontinue development of BIIB122 in idiopathic Parkinson's disease
• Denali continues to independently conduct the Phase 2a BEACON study in carriers of a pathogenic LRRK2 variant
  
  
  
   

CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif., May 21, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ:BIIB) and Denali Therapeutics Inc. (NASDAQ:DNLI) today announced topline results from the Phase 2b LUMA study evaluating BIIB122 (DNL151), an investigational small molecule inhibitor of LRRK2 (leucine-rich repeat kinase 2), in individuals with early-stage Parkinson's disease. Results from the study show that BIIB122 did not slow the progression of Parkinson's disease versus placebo, as measured by the primary endpoint of Time to Confirmed Worsening in the modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and III combined score. Secondary endpoints also did not show a benefit with BIIB122. Exploratory biomarker endpoints demonstrated >90% kinase inhibition of peripheral LRRK2 (phosphoserine 935) and, in a cerebrospinal fluid (CSF) sub-study, up to approximately 30% reduction observed in a biomarker of LRRK2 activity (phosphorylated Rab10). Expected levels of BIIB122 in the blood and CSF were sustained across the study. BIIB122 was generally well tolerated with an acceptable safety profile. Based on these results, Biogen and Denali will discontinue further development of BIIB122 in idiopathic Parkinson's disease. Denali will continue to independently conduct the Phase 2a BEACON study evaluating the small molecule inhibitor in carriers of a pathogenic LRRK2 variant.