Denali therapeutics announces fda acceptance and priority review of biologics license application (bla) for tividenofusp alfa for hunter syndrome (mps ii)

Fda assigns pdufa target action date of january 5, 2026, for decision on accelerated approval tividenofusp alfa is designed to deliver missing enzyme to entire body and cross blood-brain barrier into the brain tividenofusp alfa leads company's broader transportvehicle™-enabled pipeline south san francisco, calif., july 07, 2025 (globe newswire) -- denali therapeutics inc. (nasdaq: dnli) today announced that the u.s. food and drug administration (fda) has accepted for review the biologics license application (bla) seeking accelerated approval for tividenofusp alfa for the treatment of hunter syndrome (mucopolysaccharidoses type ii, or mps ii), a rare and progressive genetic disorder.
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