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SOUTH SAN FRANCISCO, Calif., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the publication of results from the open-label Phase 1/2 clinical trial of its investigational, next-generation enzyme replacement therapy (ERT), tividenofusp alfa (DNL310), for the treatment of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) in the January 1, 2026 issue of The New England Journal of Medicine. The U.S. Food and Drug Administration (FDA) is conducting a Priority Review of the Biologics License Application (BLA) for tividenofusp alfa, which is supported by these data and for which Denali is seeking accelerated approval. A decision by the FDA on the tividenofusp alfa BLA is expected by April 5, 2026.
Denali Therapeutics Inc. is maintained at a Strong Buy rating, driven by progress in its MPS II [Hunter Syndrome] program with tividenofusp alfa. Despite discontinuing ALS efforts, DNLI's BLA for tividenofusp alfa is under FDA Priority Review under Accelerated Approval pathway, with PDUFA date extended to April 5, 2026. Company's ETV platform enables expansion into additional lysosomal storage disorders, with DNL126 for MPS IIIA offering near-term catalysts and proof of platform versatility.
The WisdomTree Global ex-U.S. Quality Dividend Growth ETF (DNL) was launched on 06/16/2006, and is a smart beta exchange traded fund designed to offer broad exposure to the World ETFs category of the market.
A smart beta exchange traded fund, the WisdomTree Global ex-U.S. Quality Dividend Growth ETF (DNL) debuted on 06/16/2006, and offers broad exposure to the World ETFs category of the market.
Launched on 06/16/2006, the WisdomTree Global ex-U.S. Quality Dividend Growth ETF (DNL) is a smart beta exchange traded fund offering broad exposure to the World ETFs category of the market.
WisdomTree Global ex‐U.S. Quality Dividend Growth Fund holds 300 ex-US dividend stocks, focusing on quality and growth metrics. DNL is diversified across holdings, sectors, and countries, with significant exposure to industrials and technology, and limited exposure to China. DNL has lagged an ex-US benchmark and its competitors over the last 12 months.
SOUTH SAN FRANCISCO, Calif., April 02, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the company's initiation of a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II) has been received by the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). Denali continues to have regular, collaborative, and productive engagement with CDER and is aligned with CDER on the content of the BLA data package, including the use of cerebrospinal fluid heparan sulfate (CSF HS) as a surrogate endpoint to support an accelerated approval, as well as the full approval conversion path. Denali expects to complete the BLA submission in the first half of May 2025 and continues to prepare for a potential commercial launch in the U.S. in late 2025 or early 2026.
Designed to provide broad exposure to the World ETFs category of the market, the WisdomTree Global ex-U.S. Quality Dividend Growth ETF (DNL) is a smart beta exchange traded fund launched on 06/16/2006.