Denali Therapeutics Announces Successful Meeting with the FDA and Plans to File for Accelerated Approval of Tividenofusp Alfa (DNL310) for the Treatment of MPS II (Hunter Syndrome)
Denali Therapeutics Inc. (DNLI)
Last denali therapeutics inc. earnings: 8/6 04:30 pm
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Source: GlobeNewswire
Recent successful meeting with the FDA provides path to file for accelerated approval and subsequent conversion to full approvalPlan to submit biologics license application (BLA) early in 2025 under the accelerated approval pathwayNew Phase 1/2 data will be presented this week at SSIEM 2024 demonstrating robust and durable biomarker responses and positive effects on clinical outcomes SOUTH SAN FRANCISCO, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the outcome of a recent successful meeting with the Center for Drug Evaluation and Research (CDER) division of the U.S. Food and Drug Administration (FDA) providing a path to filing a biologics license application (BLA) for accelerated approval and subsequent conversion to full approval for tividenofusp alfa (DNL310) for the treatment of MPS II (Hunter syndrome). Agreement was reached that cerebrospinal fluid heparan sulfate (CSF HS) is reasonably likely to predict clinical benefit an
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- Denali Therapeutics Inc. (NASDAQ: DNLI) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald. They now have a $35.00 price target on the stock.MarketBeat
- Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug Wed, Sep 4, 2024, 5:37 PM GMT+2 4 min read 0 In this article: Denali's Plans for Tividenofusp Alfa Denali Presents New Data on Tividenofusp Alfa Our Take DNLI's Rank and Stocks to ConAcquire Media Monitor
- Denali Therapeutics Inc. (NASDAQ: DNLI) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $90.00 price target on the stock.MarketBeat
DNLI
Earnings
- 2/27/24 - Miss
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Sec Filings
- 9/16/24 - Form 4
- 9/13/24 - Form 144
- 9/4/24 - Form 4
- DNLI's page on the SEC website