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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DNLI
News
- Denali Therapeutics Inc. (NASDAQ: DNLI) is now covered by analysts at Deutsche Bank Aktiengesellschaft. They set a "buy" rating and a $31.00 price target on the stock.MarketBeat
- Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa [Yahoo! Finance]Yahoo! Finance
- Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp AlfaGlobeNewswire
- Denali Therapeutics Announces Upcoming Presentations on Hunter Syndrome (MPS II) and TransportVehicle™ Enabled Investigational Therapeutic Tividenofusp Alfa at the 2025 WORLDSymposium™ [Yahoo! Finance]Yahoo! Finance
- Denali Therapeutics Announces Upcoming Presentations on Hunter Syndrome (MPS II) and TransportVehicle™ Enabled Investigational Therapeutic Tividenofusp Alfa at the 2025 WORLDSymposium™GlobeNewswire
DNLI
Earnings
- 11/6/24 - Miss
DNLI
Sec Filings
- 2/13/25 - Form SCHEDULE
- 2/12/25 - Form SCHEDULE
- 1/13/25 - Form 8-K
- DNLI's page on the SEC website