Eclitasertib

Denali Therapeutics' tividenofusp alfa (DNL310) has received Breakthrough Therapy Designation from the FDA for Hunter syndrome (MPS II).

Denali Therapeutics' DNL343, an eIF2B agonist, did not meet the primary endpoint of slowing ALS disease progression in a Phase 2/3 trial.

Teva and Sanofi's duvakitug met primary endpoints in a Phase 2b trial for ulcerative colitis (UC) and Crohn's disease (CD).

Sanofi and Denali Therapeutics have discontinued the Phase 2 K2 clinical trial of oditrasertib in multiple sclerosis due to its failure to meet primary and key secondary endpoints.

Denali Therapeutics reported positive two-year clinical data for tividenofusp alfa in MPS II, showing sustained normalization of heparan sulfate in CSF and improvements in clinical outcomes.