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<title>Denali Therapeutics Inc — News on 6ix</title>
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<title>Denali Therapeutics Inc</title>
<link>https://6ix.com/company/denali-therapeutics-inc</link>
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<title>Orsini Selected as the Exclusive Specialty Pharmacy and Home Infusion Partner for Denali Therapeutics' AVLAYAH™ (tividenofusp alfa-eknm)</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/orsini-selected-as-the-exclusive-specialty-pharmacy-and-home-infusion-partner-for-denali-therapeutics-avlayahtm-tividenofusp-alfa-eknm</link>
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<pubDate>Mon, 20 Apr 2026 13:00:00 GMT</pubDate>
<description>Orsini, a leader in rare disease pharmacy solutions, announced today that it is the exclusive specialty pharmacy partner for Denali Therapeutics' AVLAYAH™ (tividenofusp alfa-eknm), an FDA-approved enzyme replacement therapy for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.. Read the full Prescribing Informati</description>
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<title>Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-regains-full-rights-to-investigational-therapy-dnl593-ptvpgrn-for-grn-related-frontotemporal-dementia-ftd-grn</link>
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<pubDate>Fri, 03 Apr 2026 04:00:00 GMT</pubDate>
<description>Denali plans to continue clinical development of DNL593, which is designed to deliver progranulin to the brain using TransportVehicle™ technologyResults from</description>
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<title>Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-announces-us-fda-approval-of-avlayahtm-tividenofusp-alfa-eknm-for-treatment-of-hunter-syndrome-mps-ii</link>
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<pubDate>Wed, 25 Mar 2026 04:00:00 GMT</pubDate>
<description>First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage diseaseFirst FDA-approved medicine in emerging</description>
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<title>Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-reports-fourth-quarter-and-full-year-2025-financial-results-and-business-highlights</link>
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<pubDate>Thu, 26 Feb 2026 21:01:00 GMT</pubDate>
<description>Tividenofusp alfa (DNL310; ETV:IDS) launch readiness established ahead of April 5, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Hunter syndromeDNL126 (ETV:SGSH) Phase 1/2 preliminary data presented at 2026 WORLDSymposium™, supporting plans to pursue an accelerated approval path in Sanfilippo syndrome type AStart-up activities underway for DNL628 (OTV:MAPT) Phase 1b study for Alzheimer's disease and DNL952 (ETV:GAA) Phase 1 study for late-onset Pompe diseaseTransportVehicle™</description>
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<title>Denali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-presents-enzyme-transportvehicle-190000914</link>
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<pubDate>Thu, 05 Feb 2026 19:00:00 GMT</pubDate>
<description>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</description>
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<title>Denali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-host-webcast-highlighting-presentations-enzyme-transportvehicletm</link>
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<pubDate>Mon, 02 Feb 2026 05:00:00 GMT</pubDate>
<description>SOUTH SAN FRANCISCO, Calif., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that management will host a live</description>
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<title>Denali Therapeutics Announces Data Presentations on Enzyme TransportVehicle™ Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium™</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-announces-data-presentations-enzyme-transportvehicletm-programs</link>
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<pubDate>Thu, 29 Jan 2026 05:00:00 GMT</pubDate>
<description>Hunter syndrome (MPS II) presentations will include analysis from continued follow-up of Phase 1/2 data for tividenofusp alfa (DNL310), currently under FDA</description>
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<title>Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-announces-key-anticipated-milestones-and-priorities-2026</link>
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<pubDate>Tue, 06 Jan 2026 05:00:00 GMT</pubDate>
<description>Preparing for FDA approval and commercial launch of tividenofusp alfa, Denali’s TransportVehicle™ (TV)-enabled investigational therapy for Hunter</description>
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<title>The New England Journal of Medicine Publishes Phase 1/2 Study of Denali Therapeutics’ Tividenofusp Alfa (DNL310) for Hunter Syndrome (MPS II)</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/new-england-journal-medicine-publishes-phase-1-2-study-denali-therapeutics</link>
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<pubDate>Tue, 30 Dec 2025 05:00:00 GMT</pubDate>
<description>Tividenofusp alfa treatment showed reduction and normalization in key disease biomarkers, stabilization or improvement in clinical endpoints including</description>
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<title>Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-announces-pricing-public-offering-common-stock-and-pre-funded</link>
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<pubDate>Wed, 10 Dec 2025 05:00:00 GMT</pubDate>
<description>SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the pricing of its underwritten public</description>
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<title>Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-announces-proposed-offering-common-stock-and-pre-funded-warrants</link>
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<pubDate>Tue, 09 Dec 2025 05:00:00 GMT</pubDate>
<description>SOUTH SAN FRANCISCO, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced that it intends to offer and sell $200</description>
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<title>Royalty Pharma and Denali Therapeutics Announce $275 Million Royalty Funding Agreement</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/royalty-pharma-and-denali-therapeutics-announce-275-million-royalty-funding-agreement-1</link>
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<pubDate>Thu, 04 Dec 2025 05:00:00 GMT</pubDate>
<description>NEW YORK and SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) and Denali Therapeutics, Inc. (Nasdaq: DNLI)</description>
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<title>Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-and-royalty-pharma-announce-275-million-royalty-funding-agreement-1</link>
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<pubDate>Thu, 04 Dec 2025 05:00:00 GMT</pubDate>
<description>SOUTH SAN FRANCISCO, Calif. and NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) and Royalty Pharma plc (Nasdaq: RPRX)</description>
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<title>Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-reports-third-quarter-2025-financial-results-and-business</link>
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<pubDate>Thu, 06 Nov 2025 05:00:00 GMT</pubDate>
<description>Tividenofusp alfa BLA review process for accelerated approval for MPS II continues with productive engagement with the FDA; commercial launch preparations on</description>
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<title>Denali Therapeutics Announces Board and Executive Leadership Updates</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-announces-board-and-executive-leadership-updates-2025-11-06</link>
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<pubDate>Thu, 06 Nov 2025 05:00:00 GMT</pubDate>
<description>SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced updates to its Board of Directors and</description>
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<title>Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-announces-fda-review-extension-bla-tividenofusp-alfa-treatment</link>
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<pubDate>Mon, 13 Oct 2025 04:00:00 GMT</pubDate>
<description>SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that the U.S. Food and Drug</description>
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<title>Denali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-reports-second-quarter-2025-financial-results-and-business</link>
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<pubDate>Mon, 11 Aug 2025 04:00:00 GMT</pubDate>
<description>Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of January 5, 2026; company preparing for</description>
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<title>Royalty Pharma Appoints Carole Ho and Elizabeth Weatherman to the Company’s Board of Directors</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/royalty-pharma-appoints-carole-ho-and-elizabeth-weatherman-to-the-companys-board-of-directors</link>
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<pubDate>Thu, 17 Jul 2025 12:15:00 GMT</pubDate>
<description>Strengthens Board of Directors with appointment of two new independent members, increasing independent representation to greater than 90%Underscores Royalty Pharma’s commitment to enhanced corporate governance following acquisition of its external manager NEW YORK, July 17, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced the appointment of Carole Ho and Elizabeth (Bess) Weatherman to its Board of Directors, effective immediately. Carole Ho is Chief Medical Officer and</description>
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<title>Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II)</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-announces-fda-acceptance-and-priority-review-biologics-license</link>
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<pubDate>Mon, 07 Jul 2025 04:00:00 GMT</pubDate>
<description>FDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approvalTividenofusp alfa is designed to deliver missing enzyme to entire</description>
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<title>Denali Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights Including Completion of BLA Rolling Submission for Tividenofusp Alfa for Hunter Syndrome</title>
<link>https://6ix.com/company/denali-therapeutics-inc/news/denali-therapeutics-reports-first-quarter-2025-financial-results-and-business</link>
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<pubDate>Tue, 06 May 2025 04:00:00 GMT</pubDate>
<description>SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter</description>
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