Yahoo Finance17d
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.
Yahoo Finance16d
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, tividenofusp alfa (DNL310), for the treatment of individuals with ...
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Denali obtains Breakthrough Therapy Designation for its experimental candidate, tividenofusp alfa (DNL310), for the treatment of pateints with Hunter syndrome.
Mena FN17d
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted To Tividenofusp Alfa For The Treatment Of Hunter Syndrome (MPS II)
(MENAFN- GlobeNewsWire - Nasdaq) Denali expects to submit a Biologics License Application for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway “FDA ...
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
Detailed price information for Denali Therapeutics Inc (DNLI-Q) from The Globe and Mail including charting and trades.
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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).