{"id":1015793,"date":"2026-10-30T09:33:11","date_gmt":"2026-10-30T13:33:11","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\/"},"modified":"2026-10-30T09:33:11","modified_gmt":"2026-10-30T13:33:11","slug":"denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\/","title":{"rendered":"Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH\u00ae (tividenofusp alfa-eknm) as Best Biotechnology Product"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li style=\"margin-bottom:8pt\">\n          <em>First FDA-approved biologic specifically designed to cross blood-brain barrier wins award dedicated to exceptional scientific leadership and transformational impact on patient care<\/em>\n        <\/li>\n<li style=\"margin-bottom:8pt\">\n          <em>First new FDA-approved treatment option in nearly 20 years for families living with Hunter syndrome, a rare neurodegenerative disorder<\/em>\n        <\/li>\n<li style=\"margin-bottom:8pt\">\n          <em>Denali\u2019s brain delivery technology establishes foundation for potential therapies across wide range of diseases that impact the brain, including Alzheimer\u2019s disease<\/em>\n        <\/li>\n<\/ul>\n<p>SOUTH SAN FRANCISCO, Calif., Oct.  30, 2026  (GLOBE NEWSWIRE) &#8212; Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that AVLAYAH<sup>\u00ae<\/sup> (tividenofusp alfa-eknm) has been recognized as the \u201cBest Biotechnology Product\u201d of 2026 by <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Lc4gxq-HVJK7mw0Lvt-NcKaoU898ew82l9Q_mUv3I9R-E4lPphmOys-QhIw5yLM_lIjBdbniGRrGJ-IvaA1NscSBIZ7iFeZcdo5PCaleW7a_MmjPt8AXNyD6yKwBEcNW\" rel=\"nofollow\" target=\"_blank\">The Galien Foundation<\/a>. AVLAYAH is the first biologic approved by the U.S. Food and Drug Administration (FDA) that is specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. AVLAYAH is an enzyme replacement therapy that received FDA accelerated approval in March 2026 for the treatment of neurologic manifestations of a rare neurodegenerative disease called 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. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory study.<\/p>\n<p>The Galien Foundation, which fosters and recognizes excellence in scientific innovation that improves the state of human health, presented the 2026 Prix Galien USA \u201cBest Biotechnology Product\u201d award to Denali Therapeutics during a ceremony last night at the American Museum of Natural History in New York City. Prix Galien USA Awards are among the highest honors in the global biopharmaceutical industry, acknowledging the most impactful treatments approved by the FDA within the last five years. Prix Galien winners are selected by committees of the top leaders in science and medicine.<\/p>\n<p>\u201cWe are honored to receive the Best Biotechnology Product Award for AVLAYAH, which is a culmination of years of pioneering research to solve the challenge of delivering biologics across the blood-brain barrier with our TransportVehicle technology,\u201d said Ryan Watts, Ph.D., co-founder and Chief Executive Officer of Denali Therapeutics. \u201cThis recognition also belongs to the Hunter syndrome community and the families, advocates and clinicians whose determination and commitment made AVLAYAH possible. An FDA-approved medicine that reaches the brain offers transformative possibilities for this community, and it is proof that we can bring the power of biologic medicines to the brain for rare genetic diseases and common neurodegenerative disorders that affect millions of people worldwide.\u201d<\/p>\n<p>Denali\u2019s proprietary TransportVehicle\u2122 technology binds to the transferrin receptor (TfR) and is designed to deliver enzymes, antibodies and oligonucleotides to the whole body, including the brain, through receptor-mediated transcytosis. AVLAYAH is the first and only FDA-approved TfR-enabled medicine engineered to specifically cross the blood-brain barrier.<\/p>\n<p>Denali Therapeutics is advancing a growing portfolio of TransportVehicle-enabled therapeutic candidates across all stages of development, including zafinofusp alfa, an investigational enzyme replacement therapy for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo syndrome type A), and two investigational medicines for Alzheimer\u2019s disease (AD) that target the two defining pathologies of the disease. DNL628 (OTV:MAPT) is an Oligonucleotide TransportVehicle-enabled antisense oligonucleotide designed for systemic delivery across the blood-brain barrier to reduce tau by targeting the MAPT gene for the treatment of AD. DNL921 (ATV:Abeta) is an Antibody TransportVehicle-enabled antibody designed for systemic delivery across the blood-brain barrier to target amyloid plaques in AD.<\/p>\n<p>\n        <strong>About Hunter Syndrome (MPS II)<\/strong>\n      <\/p>\n<p>Hunter syndrome, also known as MPS II, is a rare genetic lysosomal storage disorder that primarily affects boys and impacts approximately 500 individuals in the United States and 2,000 individuals worldwide. The disease is caused by mutations in the iduronate 2-sulfatase (IDS) gene that results in a deficiency of the IDS enzyme, which is responsible for breaking down glycosaminoglycans (GAGs) such as heparan sulfate and dermatan sulfate. The accumulation of GAGs leads to progressive damage in multiple organs and tissues, including the brain. Symptoms of Hunter syndrome include developmental delays, cognitive decline, behavioral abnormalities and physical complications such as joint stiffness, hearing loss and organ dysfunction.<\/p>\n<p>\n        <strong>About AVLAYAH\u00ae (tividenofusp alfa-eknm)<\/strong>\n      <\/p>\n<p>AVLAYAH (tividenofusp alfa-eknm) is an intravenous enzyme replacement therapy composed of the iduronate 2-sulfatase (IDS) enzyme fused to Denali\u2019s proprietary TransportVehicle\u2122 (TV) platform. The Fc component of AVLAYAH binds to the apical domain of the transferrin receptor (TfR) and delivers IDS to peripheral tissues and to the central nervous system through receptor-mediated transcytosis across the blood-brain barrier. AVLAYAH is internalized via binding to the mannose-6-phosphate receptor on the cell surface and transported into lysosomes where it is thought to exert enzymatic activity and reduce accumulated glycosaminoglycans (GAGs). In addition, since TfR is ubiquitously expressed, it is expected that the interaction of AVLAYAH and TfR will contribute to its uptake into cells in the brain and peripheral tissues. In addition to Rare Pediatric Disease Designation and Breakthrough Therapy Designation, the U.S. Food and Drug Administration granted Fast Track and Orphan Drug designations to AVLAYAH for the treatment of MPS II.<\/p>\n<p>The European Medicines Agency has granted Priority Medicines designation to tividenofusp alfa. AVLAYAH is not approved by health authorities outside of the U.S.<\/p>\n<p>\n        <strong>AVLAYAH U.S. Indication <\/strong>\n      <\/p>\n<p>AVLAYAH is approved for the treatment of neurologic symptoms in pediatric patients weighing at least 5 kg with Hunter syndrome prior to advanced neurologic disease. This approval is based on a reduction of heparan sulfate (HS) in the cerebrospinal fluid (CSF) surrounding the brain and spinal cord. Studies are ongoing to confirm how well it works in improving clinical symptoms.<\/p>\n<p>\n        <strong>Limitations of Use<\/strong>\n      <\/p>\n<p>AVLAYAH is not recommended for use in combination with other enzyme replacement therapies.<\/p>\n<p>\n        <strong>Important Safety Information<\/strong>\n      <\/p>\n<p>\n        <strong>AVLAYAH may cause serious side effects, including:<\/strong>\n      <\/p>\n<p>\n        <strong>Hypersensitivity Reactions including Anaphylaxis. <\/strong>Life-threatening allergic reactions occurred both early in treatment and after many doses over time, including:<\/p>\n<ul type=\"disc\">\n<li style=\"margin-bottom:8pt\">Fast heartbeat<\/li>\n<li style=\"margin-bottom:8pt\">Dizziness or fainting<\/li>\n<li style=\"margin-bottom:8pt\">Wheezing<\/li>\n<li style=\"margin-bottom:8pt\">Vomiting<\/li>\n<li style=\"margin-bottom:8pt\">Hives<\/li>\n<li style=\"margin-bottom:8pt\">Swelling of the lips and tongue<\/li>\n<\/ul>\n<p>Notify your healthcare provider immediately if these symptoms occur. If a serious allergic reaction happens, your treatment will be stopped and emergency treatment will be given, including use of epinephrine.<\/p>\n<p>\n        <strong>Infusion-Associated Reactions (IARs). <\/strong>IARs occurred during or within 24 hours after receiving AVLAYAH, including:<\/p>\n<ul type=\"disc\">\n<li style=\"margin-bottom:8pt\">Chills<\/li>\n<li style=\"margin-bottom:8pt\">Swelling<\/li>\n<li style=\"margin-bottom:8pt\">Low blood pressure (dizziness or fainting)<\/li>\n<li style=\"margin-bottom:8pt\">Fast heartbeat<\/li>\n<li style=\"margin-bottom:8pt\">Hives<\/li>\n<li style=\"margin-bottom:8pt\">Wheezing<\/li>\n<li style=\"margin-bottom:8pt\">Fever<\/li>\n<li style=\"margin-bottom:8pt\">Flushing or reddening of the skin<\/li>\n<li style=\"margin-bottom:8pt\">Rash<\/li>\n<li style=\"margin-bottom:8pt\">Cough<\/li>\n<li style=\"margin-bottom:8pt\">Diarrhea<\/li>\n<li style=\"margin-bottom:8pt\">Abdominal pain<\/li>\n<li style=\"margin-bottom:8pt\">Vomiting<\/li>\n<li style=\"margin-bottom:8pt\">Headache<\/li>\n<li style=\"margin-bottom:8pt\">Irritability<\/li>\n<li style=\"margin-bottom:8pt\">Small bumps on the skin<\/li>\n<\/ul>\n<p>If you have an IAR, your doctor may slow down, pause, adjust your dose, or stop the infusion depending on how serious the reaction is. You may also be given medicine before infusions to help prevent these reactions. Patients with heart or lung problems may be at higher risk of serious complications from these reactions and will be monitored closely.<\/p>\n<p>\n        <strong>Anemia (Low Red Blood Cell Count)<\/strong> occurred during AVLAYAH treatment and may require periodic laboratory tests for hemoglobin. Contact your healthcare provider if you experience any symptoms (e.g., fatigue, pale skin) suggestive of anemia.<\/p>\n<p>\n        <strong>Membranous Nephropathy (Kidney disorder that affects the filters that help remove wastes and fluids from the kidney) <\/strong>occurred in an AVLAYAH-treated patient. Your doctor will monitor your kidney function during treatment.<\/p>\n<p>\n        <strong>The most common side effects (in 20% or more of patients):<\/strong>\n      <\/p>\n<ul type=\"disc\">\n<li style=\"margin-bottom:8pt\">Infusion-associated reactions<\/li>\n<li style=\"margin-bottom:8pt\">Upper respiratory infections<\/li>\n<li style=\"margin-bottom:8pt\">Ear infection<\/li>\n<li style=\"margin-bottom:8pt\">Fever<\/li>\n<li style=\"margin-bottom:8pt\">Anemia (low red blood cell count)<\/li>\n<li style=\"margin-bottom:8pt\">Cough<\/li>\n<li style=\"margin-bottom:8pt\">Vomiting<\/li>\n<li style=\"margin-bottom:8pt\">Diarrhea<\/li>\n<li style=\"margin-bottom:8pt\">Rash<\/li>\n<li style=\"margin-bottom:8pt\">COVID-19<\/li>\n<li style=\"margin-bottom:8pt\">Runny or congested nose<\/li>\n<li style=\"margin-bottom:8pt\">Falls<\/li>\n<li style=\"margin-bottom:8pt\">Headache<\/li>\n<li style=\"margin-bottom:8pt\">Skin injuries<\/li>\n<li style=\"margin-bottom:8pt\">Hives<\/li>\n<\/ul>\n<p>Contact your healthcare provider right away if you experience any side effects. These are not all the possible side effects of AVLAYAH. You may report side effects to FDA at\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=JsPxFfORJcZZwaQ28WE7mieKJimXTEkl-bhebUsTwHvcqAeGFwWU5SxpZ7nNNtH9QF9V_RqL9lGnaCdNhwbpC5KMFGVGpKgjmP795btWRvM=\" rel=\"nofollow\" target=\"_blank\">www.fda.gov\/medwatch<\/a> or call 1-800-FDA-1088. You may also report side effects to Denali Therapeutics at 1-833-ONE-DNLI (1-833-663-3654).<\/p>\n<p>\n        <strong>Please see the full Prescribing Information, including Boxed Warning, <\/strong><br \/>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=xdELcS6Dwt1eq4P_NCWNBj5GHiXaSRukfMz-x5Det1Hlab8WXeTEmmrk2NH15RXz3eoItIGyle7KntKSahyoAivXXSlYc45M1hgseCsTeKJE-dYYVzxl1fFo6VBtV4GJhs3F07I4vHHjRQfbIgoyJOKkhM-LYPbmKZ4i7-NolPg=\" rel=\"nofollow\" target=\"_blank\"><br \/>\n          <strong>here<\/strong><br \/>\n        <\/a><br \/>\n        <strong> for additional Important Safety Information.<\/strong>\n      <\/p>\n<p>\n        <strong>About the Denali TransportVehicle<\/strong><br \/>\n        <sup>\u2122<\/sup><br \/>\n        <strong> Platform<\/strong><br \/>\n        \n      <\/p>\n<p>The blood-brain barrier (BBB) is essential in maintaining the brain\u2019s microenvironment and protecting it from harmful substances and pathogens circulating in the bloodstream. Historically, the BBB has posed significant challenges to drug development for central nervous system diseases by preventing most drugs from reaching the brain in therapeutically relevant concentrations. Denali\u2019s TransportVehicle\u2122 (TV) platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes and oligonucleotides throughout the whole body, including the brain, by crossing the BBB after intravenous administration. The TV platform is based on engineered Fc domains that bind to specific natural transport receptors, such as transferrin receptor and CD98 heavy chain amino acid transporter, which are expressed at the BBB and deliver the TV and its therapeutic cargo to the brain through receptor-mediated transcytosis. In animal models, antibodies and enzymes engineered with the TV platform demonstrate more than 10- to 30-fold greater brain exposure than similar antibodies and enzymes without this technology. Oligonucleotides engineered with the TV platform demonstrate more than a 1,000-fold greater brain exposure in primates than systemically delivered oligonucleotides without this technology. Improved exposure and broad distribution in the brain may increase therapeutic efficacy by enabling widespread achievement of therapeutically relevant concentrations of product candidates. The TV platform has been clinically validated, with AVLAYAH\u00ae (tividenofusp alfa-eknm) as the first FDA-approved medicine leveraging transferrin receptor to cross the BBB.<\/p>\n<p>\n        <strong>About Denali Therapeutics<\/strong>\n      <\/p>\n<p>Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle\u2122 platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, Denali is advancing toward its goal of delivering effective medicines to transform life for people with neurodegenerative diseases, lysosomal storage disorders and other serious diseases. For more information, please visit www.denalitherapeutics.com.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding expectations for Denali\u2019s TransportVehicle\u2122 (TV) platform, including its therapeutic and commercial potential and its potential to enable therapies across a wide range of diseases that impact the brain; AVLAYAH<sup>\u00ae<\/sup> (tividenofusp alfa-eknm), including its therapeutic potential and the likelihood that confirmatory studies will verify clinical benefit and support continued approval; plans, timelines and expectations related to zafinofusp alfa, DNL628, DNL921 and Denali\u2019s other TV-enabled product candidates; and statements by Denali&#8217;s Chief Executive Officer. Actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of risks and uncertainties. These include, but are not limited to, risks arising from adverse economic conditions and their impact on Denali\u2019s business and operations; Denali\u2019s ability to complete the development and, if approved, the commercialization of product candidates; reliance on third-party manufacturers and suppliers for clinical trial and commercial materials; difficulties enrolling patients for ongoing and future clinical trials; potential delays or failures in meeting expected clinical trial timelines; discrepancies between preclinical, early-stage or preliminary clinical results and later-stage trial outcomes; the risk that interim or topline clinical results may not be predictive of final study results or longer-term outcomes; the risk that the FDA may not accept the data or surrogate endpoints Denali intends to use to support accelerated approval, may require additional or different studies, or may withdraw an accelerated approval if confirmatory studies do not verify clinical benefit; significant adverse events or other undesirable side effects; the uncertainty surrounding regulatory approvals required for commercialization in the U.S., Europe or other international jurisdictions, including uncertainties related to the FDA\u2019s policies; developments relating to Denali&#8217;s competitors and competing product candidates; Denali\u2019s ability to obtain, maintain or protect intellectual property rights related to its product candidates; the implementation and success of Denali\u2019s strategic plans for its business, product candidates and blood-brain barrier platform technology; Denali&#8217;s ability to obtain additional capital to finance its operations, as needed; Denali&#8217;s ability to accurately forecast future revenues and operating expenses in the current environment; quarterly variability in net product revenue and the risk that revenue growth may not continue at recent rates; and other risks and uncertainties, including those described in Denali&#8217;s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2026, its Quarterly Report on Form 10-Q filed with the SEC on August 6, 2026, and Denali\u2019s future SEC filings. Except for AVLAYAH, Denali&#8217;s product candidates are investigational, and their safety and efficacy profiles have not yet been established. Denali undertakes no obligation to update or revise any forward-looking statements, to conform these statements to actual results or reflect changes in Denali\u2019s expectations, except as required by law.<\/p>\n<p>\n        <strong>Investor Contact:<\/strong>\n      <\/p>\n<p>Laura Hansen, Ph.D.<\/p>\n<p>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=uY8zalun1_PL9eB24OUDARprYdtESbr4uDm_46j9NlRImtk-yECXBr5Fic5WyuQWxBPqoKLpOkguWIF2pohaVOOAJjIOpOfH86wq9uiC760=\" rel=\"nofollow\" target=\"_blank\">hansen@dnli.com<\/a>\n      <\/p>\n<p>\n        <strong>Media Contact:<\/strong>\n      <\/p>\n<p>Erin Patton<\/p>\n<p>\n        <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=TU9RhEv0FrLgCM5D_lSCVf5GLq1dxZ7kEp6exr2aGDV6xJjI-wGaY9TUfTfAq0gzhsH_0Jq5yEijzeSzDcHvMeWr5BhrQl0JihEU6ZqLNAc=\" rel=\"nofollow\" target=\"_blank\">epatton@dnli.com<\/a>\n      <\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg1NjkwOCM3OTI2MDYwIzIwOTM0Njg=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/Y2IzZDY1NWYtZDY5ZS00ZjAyLWIzZmQtZTQ5YWFhNTc2OGMzLTExMDUwMzktMjAyNi0xMC0zMC1lbg==\/tiny\/Denali-Therapeutics-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>First FDA-approved biologic specifically designed to cross blood-brain barrier wins award dedicated to exceptional scientific leadership and transformational impact on patient care First new FDA-approved treatment option in nearly 20 years for families living with Hunter syndrome, a rare neurodegenerative disorder Denali\u2019s brain delivery technology establishes foundation for potential therapies across wide range of diseases that impact the brain, including Alzheimer\u2019s disease SOUTH SAN FRANCISCO, Calif., Oct. 30, 2026 (GLOBE NEWSWIRE) &#8212; Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that AVLAYAH\u00ae (tividenofusp alfa-eknm) has been recognized as the \u201cBest Biotechnology Product\u201d of 2026 by The Galien Foundation. AVLAYAH is the first biologic approved by the U.S. Food and Drug Administration (FDA) that is specifically designed to cross the blood-brain barrier &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH\u00ae (tividenofusp alfa-eknm) as Best Biotechnology Product&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-1015793","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH\u00ae (tividenofusp alfa-eknm) as Best Biotechnology Product - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH\u00ae (tividenofusp alfa-eknm) as Best Biotechnology Product - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"First FDA-approved biologic specifically designed to cross blood-brain barrier wins award dedicated to exceptional scientific leadership and transformational impact on patient care First new FDA-approved treatment option in nearly 20 years for families living with Hunter syndrome, a rare neurodegenerative disorder Denali\u2019s brain delivery technology establishes foundation for potential therapies across wide range of diseases that impact the brain, including Alzheimer\u2019s disease SOUTH SAN FRANCISCO, Calif., Oct. 30, 2026 (GLOBE NEWSWIRE) &#8212; Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that AVLAYAH\u00ae (tividenofusp alfa-eknm) has been recognized as the \u201cBest Biotechnology Product\u201d of 2026 by The Galien Foundation. AVLAYAH is the first biologic approved by the U.S. Food and Drug Administration (FDA) that is specifically designed to cross the blood-brain barrier &hellip; Continue reading &quot;Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH\u00ae (tividenofusp alfa-eknm) as Best Biotechnology Product&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-10-30T13:33:11+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg1NjkwOCM3OTI2MDYwIzIwOTM0Njg=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"10 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH\u00ae (tividenofusp alfa-eknm) as Best Biotechnology Product\",\"datePublished\":\"2026-10-30T13:33:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\\\/\"},\"wordCount\":2113,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTg1NjkwOCM3OTI2MDYwIzIwOTM0Njg=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\\\/\",\"name\":\"Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH\u00ae (tividenofusp alfa-eknm) as Best Biotechnology Product - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/denali-therapeutics-receives-2026-prix-galien-usa-award-for-avlayah-tividenofusp-alfa-eknm-as-best-biotechnology-product\/","og_locale":"en_US","og_type":"article","og_title":"Denali Therapeutics Receives 2026 Prix Galien USA Award for AVLAYAH\u00ae (tividenofusp alfa-eknm) as Best Biotechnology Product - Market Newsdesk","og_description":"First FDA-approved biologic specifically designed to cross blood-brain barrier wins award dedicated to exceptional scientific leadership and transformational impact on patient care First new FDA-approved treatment option in nearly 20 years for families living with Hunter syndrome, a rare neurodegenerative disorder Denali\u2019s brain delivery technology establishes foundation for potential therapies across wide range of diseases that impact the brain, including Alzheimer\u2019s disease SOUTH SAN FRANCISCO, Calif., Oct. 30, 2026 (GLOBE NEWSWIRE) &#8212; Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that AVLAYAH\u00ae (tividenofusp alfa-eknm) has been recognized as the \u201cBest Biotechnology Product\u201d of 2026 by The Galien Foundation. 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