Denali Therapeutics Unveils Portfolio Goals for 2026, Stock Up [Yahoo! Finance]
Denali Therapeutics Inc. (DNLI)
Last denali therapeutics inc. earnings: 8/6 04:30 pm
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Source: Yahoo! Finance
Denali Therapeutics is preparing for the anticipated FDA approval and commercial launch of tividenofusp alfa, its investigational therapy for Hunter syndrome. The company expects 2026 to mark the first commercial validation of its platform. Shares of Denali Therapeutics gained 7.43% yesterday and were up 2.5% in after-market trading. Denali Therapeutics is developing DNL310 or tividenofuspalfa, an Enzyme Transport Vehicle (ETV)-enabled iduronate-2-sulfatase (IDS) replacement therapy, for the treatment of MPS II (Hunter syndrome). It is designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain. Denali Therapeutics submitted a biologics license application (BLA) for tividenofuspalfa under the FDA's accelerated approval pathway based on data from the phase I/II study in participants with Hunter syndrome. However, in October 2025, the FDA extended its review timeline of the BLA seeking accelerated approval of
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News
- Denali Therapeutics (NASDAQ:DNLI) had its "overweight" rating reaffirmed by analysts at Morgan Stanley.MarketBeat
- Assessing Denali Therapeutics (DNLI) Valuation After Positive Hunter Syndrome Trial Data And FDA Priority Review [Yahoo! Finance]Yahoo! Finance
- Denali Therapeutics (NASDAQ:DNLI) is now covered by analysts at UBS Group AG. They set a "buy" rating on the stock.MarketBeat
- Denali Therapeutics (NASDAQ:DNLI) was given a new $25.00 price target on by analysts at UBS Group AG.MarketBeat
- Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter SyndromeGlobeNewswire
DNLI
Earnings
- 11/6/25 - Beat
DNLI
Sec Filings
- 1/8/26 - Form 4
- 1/8/26 - Form 4
- 1/6/26 - Form 144
- DNLI's page on the SEC website