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Denali Therapeutics Showcases ETV Data at WORLD: TIVI PDUFA Near, DNL126 Hits 80% CSF Drop
Denali Therapeutics (NASDAQ:DNLI) used an analyst call from the 2026 WORLD Symposium in San Diego to highlight new and updated data from its enzyme transport vehicle (ETV) franchise, including clinical follow-up for tividenofusp alfa (TIVI) in Hunter syndrome (MPS II), preliminary Phase 1/2 biomarke Feb 5, 2026 - $DNLI
A Look At Denali Therapeutics (DNLI) Valuation As New ETV Rare Disease Data Presentations Approach
Denali Therapeutics (DNLI) is back in focus after detailing plans to showcase new clinical and preclinical data from its Enzyme Transport Vehicle programs at the WORLDSymposium, alongside a shareholder and analyst call. See our latest analysis for Denali Therapeutics. The upcoming WORLDSymposium data releases and shareholder call arrive after a strong 90 day share price return of 47.68% and a 30 day share price return of 32.83%, although the 1 year total shareholder return is still a 9.79%... Feb 5, 2026 - $DNLI
Denali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™
Analysis from continued follow-up of Phase 1/2 clinical trial data in Hunter syndrome (MPS II) reinforces potential for tividenofusp alfa (DNL310) to address full disease spectrumLaunch readiness established in anticipation of April 5, 2026, Prescription Drug User Fee Act (PDUFA) date for tividenofusp alfaPreliminary Phase 1/2 study data show treatment with DNL126 (ETV:SGSH) substantially reduced disease biomarkers in cerebrospinal fluid (CSF) and peripheral tissues, including an 80% mean reduct Feb 5, 2026 - $DNLI
How Denali’s Brain-Targeted ETV Data and FDA Review Will Impact Denali Therapeutics (DNLI) Investors
Denali Therapeutics announced it will present past and ongoing clinical and preclinical data from its Enzyme TransportVehicle (ETV) programs at the 22nd Annual WORLDSymposium in San Diego, highlighting investigational treatments for Hunter syndrome, Sanfilippo syndrome type A, and Pompe disease, alongside an FDA Priority Review of tividenofusp alfa. A key focus is Denali’s blood–brain barrier–crossing ETV platform, which in animal models has enabled much greater brain exposure for engineered... Feb 4, 2026 - $DNLI
PLX: CHMP Delivers Positive Opinion
By John Vandermosten, CFA NYSE:PLX READ THE FULL PLX RESEARCH REPORT CHMP Positive Opinion for Elfabrio Four-Week Dosing In October 2025, Protalix BioTherapeutics, Inc. (NYSE:PLX) announced that the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion regarding Chiesi’s request for four-week dosing via a post-authorization variation. In response, Chiesi and Protalix Feb 3, 2026 - $DNLI
Denali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™
SOUTH SAN FRANCISCO, Calif., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that management will host a live webcast to review presentations on its Enzyme TransportVehicle™ (ETV) programs at the upcoming 22nd Annual WORLDSymposium™ being held February 2-6, 2026, in San Diego, California. These presentations will demonstrate the broad potential of the ETV to enable the delivery of enzyme replacement therapies to the whole body, including the brain. Title Feb 2, 2026 - $DNLI
3 Biotech Stocks That Could Double In 2026
The biotech sector is one that’s become red-hot, at least in recent years. After around a decade of stagnation, investors appear to be intent on increasing their exposure to top biotech names in the market, as growth in other sectors of the economy have led to valuations that now look more elevated than the biotech ... 3 Biotech Stocks That Could Double In 2026 Jan 20, 2026 - $DNLI
The Bull Case For Denali Therapeutics (DNLI) Could Change Following NEJM Tividenofusp Data Publication And FDA Review
Denali Therapeutics announced that results from its open-label Phase 1/2 trial of tividenofusp alfa for Hunter syndrome were published in the January 1, 2026 issue of The New England Journal of Medicine, supporting an ongoing FDA Priority Review and accelerated approval request for this brain-penetrant enzyme replacement therapy. The data showed large and sustained reductions in key neurological and peripheral biomarkers, alongside improvements in liver volume, hearing, and adaptive... Jan 8, 2026 - $DNLI
Assessing Denali Therapeutics (DNLI) Valuation After Positive Hunter Syndrome Trial Data And FDA Priority Review
Denali Therapeutics (DNLI) drew fresh interest after publishing Phase 1/2 trial results for its Hunter syndrome therapy, tividenofusp alfa, in The New England Journal of Medicine, alongside ongoing FDA Priority Review and accelerated approval efforts. See our latest analysis for Denali Therapeutics. Despite the recent clinical momentum, Denali Therapeutics’ share price return tells a mixed story, with a 7 day gain of 2.67%, a 30 day share price return decline of 13.92%, a 1 year total... Jan 8, 2026 - $DNLI
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