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...
Denali Therapeutics Inc. (DNLI)
Last denali therapeutics inc. earnings: 8/6 04:30 pm
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Tividenofusp alfa (DNL310) is being evaluated for the treatment of MPS II (Hunter syndrome). The meeting with CDER outlined a path for Denali to file a biologics license application (BLA) seeking accelerated approval of tividenofusp alfa (DNL310) for the treatment of MPS II and its subsequent conversion to full approval. Shares of this biopharmaceutical company have gained 17.8% in the year to date against the industry's decline of 1%. Image Source: Zacks Investment Research Denali reached an agreement with the CDER that cerebrospinal fluid heparan sulfate (CSF HS) is reasonably likely to predict clinical benefit and can be used as a surrogate endpoint to support accelerated approval for tividenofusp alfa in MPS II. As per discussions with CDER, Denali will include preclinical and clinical data on biomarkers (CSF HS and neurofilament light [NfL]) and safety in the BLA for tividenofusp alfa as a treatment of MPS II. Denali plans to submit the BLA under the accelerated appr
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News
- Strength Seen in Denali Therapeutics (DNLI): Can Its 10.1% Jump Turn into More Strength? [Yahoo! Finance]Yahoo! Finance
- Blood Brain Barrier Market Assessment 2024-2035, Distribution by Type of Molecule, Route of Administration, Target Disease Indication, Therapeutic Area and Key Geographical Regions [Yahoo! Finance]Yahoo! Finance
- 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 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
- Denali Therapeutics Inc. (NASDAQ: DNLI) had its price target raised by analysts at Bank of America Co. from $25.00 to $29.00. They now have a "buy" rating on the stock.MarketBeat
DNLI
Earnings
- 2/27/24 - Miss
DNLI
Sec Filings
- 9/16/24 - Form 4
- 9/13/24 - Form 144
- 9/4/24 - Form 4
- DNLI's page on the SEC website