The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for tividenofusp alfa for the treatment of Hunter syndrome, also known as ...

Fifteen-year-old Dominic Henriquez from Prosper, Texas, is bringing hope to boys like him who live with Hunter syndrome, a rare genetic disorder that primarily affects males. Dominic’s journey began ...

Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, tividenofusp alfa (DNL310), for the treatment of individuals with Hunter ...

Treatments for are allergic fungal rhinosinusitis, bipolar I disorder, Hunter syndrome, Leber hereditary optic neuropathy, ovarian cancer, and schizophrenia under review.

Ongoing clinical research at UNC could lead to a first-of-its-kind enzyme replacement therapy for Hunter syndrome, an ultra-rare disorder that causes progressive multisystem disease and neurologic ...

Tividenofusp alfa treatment showed reduction and normalization in key disease biomarkers, stabilization or improvement in clinical endpoints including adaptive behavior, cognition and hearing, and ...

A child with Hunter Syndrome has amazed doctors with his progress after becoming the first person in the world to receive a pioneering gene therapy for the devastating disease. Three-year-old Oliver ...

(RTTNews) - Denali Therapeutics Inc. (DNLI), Wednesday announced that the company's initiation of a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp ...

Preparing for FDA approval and commercial launch of tividenofusp alfa, Denali’s TransportVehicle™ (TV)-enabled investigational therapy for Hunter syndromeExpecting multiple clinical data readouts from ...

The McKay family attended this successful event. The Hunter Syndrome Family Fair drew over 100 individuals from across the country impacted by this rare, life-limiting, and progressive genetic ...

Denali Therapeutics Inc. DNLI recently outlined its roadmap for 2026 across its portfolio of investigational therapies for neurodegenerative diseases, lysosomal storage disorders and other serious ...