Denali therapeutics announces primary analysis and long-term follow-up of phase 1/2 study in hunter syndrome (mps ii) with tividenofusp alfa

South san francisco, calif., feb. 06, 2025 (globe newswire) -- denali therapeutics inc. (nasdaq: dnli), today announced the primary analysis of the phase 1/2 study in 47 participants with hunter syndrome (mps ii) in the 24-week treatment period and additional long-term follow-up of its investigational therapeutic tividenofusp alfa (dnl310). these data, along with recent breakthrough therapy designation, further support the company's plan to submit a biologics license application (bla) in early 2025 for accelerated approval and deliver this potential treatment to the hunter syndrome community in late 2025 or early 2026. the phase 1/2 results are being presented this week at the 21st annual worldsymposium™ conference in san diego, california.
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