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Denali Gains 26.6% in a Year: How Should You Play the Stock?Denali Therapeutics DNLI has performed well in the past 12 months amid a volatile market. Shares of the company have gained ...
Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, tividenofusp alfa (DNL310), for the treatment of individuals with Hunter ...
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 ...
That's because it recently received FDA Breakthrough Therapy Designation [BTD] for tividenofusp alfa [DNL310] for the treatment of patients with Hunter Syndrome [also known as MPS II]. Even better ...
This designation is in addition to Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation, all previously granted by the FDA for tividenofusp alfa in Hunter syndrome.
It's JPM 2025 and here at Fierce Biotech we’re bringing you all the latest updates live from the life sciences event of the ...
Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, tividenofusp alfa (DNL310), for the treatment of individuals with ...
The company’s wholly owned program, DNL310 or tividenofusp alfa, is an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter syndrome).
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