Denali Therapeutics Inc. (DNLI) Secures FDA Priority Review for First-Ever Brain-Penetrant Hunter Syndrome Therapy

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Denali Therapeutics Inc. (NASDAQ:DNLI) is a clinical-stage biopharmaceutical company headquartered in South San Francisco, focused on developing therapies for neurodegenerative and lysosomal storage disorders. Its proprietary TransportVehicle (TV) technology enables the delivery of biologics across the blood-brain barrier, targeting neurological symptoms often left untreated by conventional therapies.

In July 2025, the company achieved a major milestone as the FDA accepted and granted Priority Review for its Biologics License Application (BLA) for tividenofusp alfa, a novel enzyme replacement therapy for Hunter syndrome (MPS II). This designation highlights the urgent medical need and sets a PDUFA decision date of January 5, 2026, opening the door for potential approval and launch by early 2026.

Tividenofusp alfa is a first-in-class brain-penetrant enzyme therapy designed to overcome a key limitation of current treatments, which do not reach the brain and fail to address neurological symptoms. In clinical trials, Denali Therapeutics Inc. (NASDAQ:DNLI)’s therapy demonstrated effective delivery of the missing enzyme to the central nervous system, showing promise for addressing both somatic and neurological aspects of Hunter syndrome.

A scientist in a labcoat inspecting a microscope focusing on a microorganism related to the biopharmaceutical company’s therapies.

If approved, this therapy would not only offer new hope for patients with Hunter syndrome but also validate the corporation’s TV platform, accelerating the development of additional treatments for other disorders like Sanfilippo syndrome (DNL126) and other central nervous system diseases. The milestone marks a transformative moment for Denali Therapeutics Inc. (NASDAQ:DNLI), potentially expanding its leadership in next-generation rare disease therapies.

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