Denali Gains 26.6% in a Year: How Should You Play the Stock?
DNLI has had a good run in the past year on positive pipeline updates. A potential approval of its Hunter Syndrome drug should be a boost. However, recent pipeline setbacks warrant caution.
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.
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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, tividenofusp alfa (DNL310), for the treatment of individuals with ...
Why Is Denali Therapeutics Stock Trading Higher On Wednesday?
Denali Therapeutics showcases its BBB platform at J.P. Morgan Conference, highlighting DNL310's Hunter syndrome progress and plans for commercialization.
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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.
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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 ...
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JPM25, Day 1: GSK's billion-dollar bet, Bayer's trial first, Lilly buys Scorpion, and more
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 ...