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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 ...
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DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Denali expects to submit a BLA for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway. DNLI’s Recent Pipeline Updates Denali recently initiated dosing ...
Business Insider20d
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
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.
Seeking Alpha19d
Denali: Despite ALS Primary Endpoint Failure, Possible Path Forward Remains
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 ...
WGN Radio20d
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
Jan. 08, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ...
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Denali Gains 26.6% in a Year: How Should You Play the Stock?
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).