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DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, ...
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for the treatment ...
Denali: Despite ALS Primary Endpoint Failure, Possible Path Forward Remains
Denali Therapeutics Inc.'s stock remains stable despite trial setback in ALS. BLA filing for MPS II treatment on track. Click ...
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Denali's ALS Study Fails to Meet Primary and Secondary Endpoints
Denali Therapeutics Inc. DNLI announced disappointing top-line results from an analysis of Regimen G of the phase II/III ...
Denali Therapeutics announces U.S. FDA BTD granted for tividenofusp
Denali Therapeutics (DNLI) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for ...
Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic
William Blair has initiated coverage on Denali Therapeutics Inc (NASDAQ:DNLI), a company focused on developing drugs for ...
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Why Is Denali Therapeutics (DNLI) Down 21.2% Since Last Earnings Report?
DNL310, or tividenofusp alfa, is an Enzyme Transport Vehicle (ETV)- enabled iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter syndrome). In September, Denali ...
Investing3d
Denali Therapeutics stock target cut, keeps buy rating on trial results
Despite these results, the analyst believes that Denali's core value lies in its Transport Vesicle (TV) platform and the promising prospects of Tividenofusp alfa, which is expected to be submitted ...
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Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic
Denali plans to submit a biologics license application for tividenofusp alfa in early 2025. The analyst highlights that Denali is developing a specialized transport vehicle (TV) platform to ...