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02.04.25 - 22:18
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What Happened To Denali Therapeutics Stock Wednesday? (Benzinga)
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Denali Therapeutics, Inc. (NASDAQ: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.
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06.02.25 - 17:45
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Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa (GlobeNewswire EN)
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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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