Denali Therapeutics ( (DNLI) ) has shared an update.
On April 2, 2025, Denali Therapeutics announced the initiation of a rolling submission for a biologics license application (BLA) for tividenofusp alfa, aimed at securing accelerated approval for treating Hunter syndrome (MPS II). This step aligns with the U.S. FDA’s Center for Drug Evaluation and Research (CDER) and includes using cerebrospinal fluid heparan sulfate as a surrogate endpoint. The company anticipates completing the BLA submission by May 2025 and is preparing for a potential U.S. commercial launch in late 2025 or early 2026. The announcement highlights Denali’s ongoing collaboration with CDER under the START program, which also supports the development of DNL126 for Sanfilippo syndrome, reflecting broader implications for expanding Denali’s Enzyme TransportVehicle franchise.
More about Denali Therapeutics
Denali Therapeutics is a biopharmaceutical company focused on developing treatments for neurodegenerative and lysosomal storage diseases. The company specializes in engineering product candidates to cross the blood-brain barrier, using genetically validated targets and biomarkers to guide development. Denali is based in South San Francisco.
YTD Price Performance: -41.03%
Average Trading Volume: 1,159,765
Technical Sentiment Signal: Buy
Current Market Cap: $1.97B
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