Denali Therapeutics, Inc. ( DNLI ) shares traded higher on Wednesday after the company initiated its biologics license application (BLA) for the accelerated approval of Tividenofusp Alfa for the treatment of Hunter syndrome.

What To Know: Denali announced that it expects the BLA application to be completed by mid-May. The company is preparing for a potential U.S. commercial launch in late 2025 or early 2026.

“We are grateful to the FDA for their ongoing support of our BLA filing and continued dedication to advance new medicines. This regulatory milestone brings us closer to our goal of delivering a new treatment option to the Hunter syndrome community as we continue to listen, learn, and seek their advice in bringing tividenofusp alfa to patients,” said Carole Ho, chief medical officer of Denali.

“Our progress has broader positive implications supporting the expansion of our Enzyme Transport Vehicle franchise of next-generation enzyme replacement therapies to treat the brain and body. In this context, we appreciate the ongoing and productive collaboration with CDER through the START program as we align on an accelerated development and approval path for DNL126 for the potential treatment of Sanfilippo syndrome.”

Denali Therapeutics ( DNLI ) is a biopharmaceutical company developing a portfolio of product candidates engineered to cross the blood-brain barrier for neurodegenerative diseases and lysosomal storage diseases.

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DNLI Price Action: Denali shares closed Wednesday up 11.8% at $13.74, according to data from Benzinga Pro.

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