{"id":13007,"date":"2025-06-19T13:30:00","date_gmt":"2025-06-19T17:30:00","guid":{"rendered":"https:\/\/sharewatch.com\/wp\/2025\/06\/19\/fda-approves-gilead\/"},"modified":"2025-06-19T13:30:00","modified_gmt":"2025-06-19T17:30:00","slug":"fda-approves-gilead","status":"publish","type":"post","link":"https:\/\/sharewatch.com\/wp\/2025\/06\/19\/fda-approves-gilead\/","title":{"rendered":"FDA Approves Gilead"},"content":{"rendered":"<div class=\"layout__region nsdq-l-grid__item syndicated-article-body\">\n<section class=\"jupiter22-c-article-body\">\n<div class=\"body\">\n<div class=\"body__content\">\n<p style=\"text-align: justify;\"><strong>Gilead Sciences, Inc<\/strong>. GILD obtained FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV.<\/p>\n<p style=\"text-align: justify;\">The regulatory body approved lenacapavir, under the brand name Yeztugo, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg.<\/p>\n<div class=\"ads__inline\">\n<div id=\"js-dfp-tag-0gE\"  class=\"btf-bodymidpagetwothirdswidth-1\">          <script type=\"text\/javascript\">         googletag.cmd.push(function() {             \/\/ Check if ID matches ID in the window.adsList array before calling googletag.display             function isAdInAdsList(id) {             for (var i = 0; i < window.adsList.length; i++) {                 if (window.adsList[i].id === id) {                     return true;                 }             }             return false;         }         if (isAdInAdsList('js-dfp-tag-0gE')) {             googletag.display('js-dfp-tag-0gE');         }         });     <\/script> <\/div>\n<\/p><\/div>\n<p style=\"text-align: justify;\">This groundbreaking injectable therapy marks the first and only twice-yearly PrEP option available in the United States.<\/p>\n<p style=\"text-align: justify;\">The FDA nod, granted under Priority Review, was based on extraordinary data from the late-stage studies, PURPOSE 1 and PURPOSE 2, which showed that \u226599.9% of participants who received Yeztugo remained HIV-negative.<\/p>\n<p style=\"text-align: justify;\">Year to date, shares of GILD have gained 18.6% against the industry\u2019s decline of 4%.\u00a0 \u00a0\u00a0<\/p>\n<p><img decoding=\"async\" alt=\"Zacks Investment Research\" src=\"https:\/\/staticx-tuner.zacks.com\/images\/articles\/charts\/ec\/109268.jpg?v=700192646\"><br \/><span style=\"width:100%; display: inline-block; font-size: 8pt;\">Image Source: Zacks Investment Research<\/span><\/p>\n<h2>More on GILD\u2019s Yeztugo<\/h2>\n<p style=\"text-align: justify;\">The approval of Yeztugo for HIV prevention is a major breakthrough in the fight against HIV epidemic.<\/p>\n<div class=\"ads__inline\">\n<div id=\"js-dfp-tag-OaE\"  class=\"btf-bodymidpagetwothirdswidth-2\">          <script type=\"text\/javascript\">         googletag.cmd.push(function() {             \/\/ Check if ID matches ID in the window.adsList array before calling googletag.display             function isAdInAdsList(id) {             for (var i = 0; i < window.adsList.length; i++) {                 if (window.adsList[i].id === id) {                     return true;                 }             }             return false;         }         if (isAdInAdsList('js-dfp-tag-OaE')) {             googletag.display('js-dfp-tag-OaE');         }         });     <\/script> <\/div>\n<\/p><\/div>\n<p style=\"text-align: justify;\">At present, there are two FDA-approved daily oral medications for PrEP \u2014 Truvada and Descovy. Both of these are marketed by GILD alone.<\/p>\n<p style=\"text-align: justify;\">Please note that Descovy for PrEP is indicated in at-risk adults and adolescents (\u226535 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex.<\/p>\n<p style=\"text-align: justify;\">Truvada is a two-drug combination of emtricitabine and tenofovir disoproxil fumarate, approved for the treatment of HIV-1 infection and PrEP.<\/p>\n<p style=\"text-align: justify;\">Data from PURPOSE 1 study showed that twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada in cisgender women in sub-Saharan Africa.<\/p>\n<p style=\"text-align: justify;\">Data from the PURPOSE 2 study showed that 99.9% of participants in the Yeztugo group did not acquire HIV infection. Yeztugo was also superiority in preventing of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people.<\/p>\n<div class=\"ads__inline\">\n<div id=\"js-dfp-tag-Zmg\"  class=\"btf-bodymidpagetwothirdswidth-3\">          <script type=\"text\/javascript\">         googletag.cmd.push(function() {             \/\/ Check if ID matches ID in the window.adsList array before calling googletag.display             function isAdInAdsList(id) {             for (var i = 0; i < window.adsList.length; i++) {                 if (window.adsList[i].id === id) {                     return true;                 }             }             return false;         }         if (isAdInAdsList('js-dfp-tag-Zmg')) {             googletag.display('js-dfp-tag-Zmg');         }         });     <\/script> <\/div>\n<\/p><\/div>\n<p style=\"text-align: justify;\">Yeztugo also demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified.<\/p>\n<p style=\"text-align: justify;\">Yeztugo was also granted Breakthrough Therapy Designation in October 2024.<\/p>\n<p style=\"text-align: justify;\">The European Medicines Agency has also validated the Marketing Authorization Application for twice-yearly lenacapavir for HIV prevention.<\/p>\n<h2>Yeztugo Approval \u2013 A Significant Boost for GILD<\/h2>\n<p style=\"text-align: justify;\">As the first long-acting injectable PrEP administered just twice a year, Yeztugo addresses persistent barriers that have limited broader PrEP adoption, such as challenges with daily oral PrEP, adherence, stigma and healthcare access.<\/p>\n<p style=\"text-align: justify;\">This approval represents a paradigm shift in HIV prevention and is expected to catalyze uptake among populations that have historically been underserved by existing prevention tools. Yeztugo has a competitive advantage as it needs to be taken only twice yearly, unlike daily oral pills, and addresses a broad population.<\/p>\n<div class=\"ads__inline\">\n<div id=\"js-dfp-tag-7nA\"  class=\"btf-bodymidpagetwothirdswidth-4\">          <script type=\"text\/javascript\">         googletag.cmd.push(function() {             \/\/ Check if ID matches ID in the window.adsList array before calling googletag.display             function isAdInAdsList(id) {             for (var i = 0; i < window.adsList.length; i++) {                 if (window.adsList[i].id === id) {                     return true;                 }             }             return false;         }         if (isAdInAdsList('js-dfp-tag-7nA')) {             googletag.display('js-dfp-tag-7nA');         }         });     <\/script> <\/div>\n<\/p><\/div>\n<p style=\"text-align: justify;\">Gilead has a market-leading portfolio of HIV treatments. Flagship drug Biktarvy accounts for over 51% share of the treatment market in the United States and should maintain momentum.<\/p>\n<p style=\"text-align: justify;\">The approval of Yeztugon solidifies its HIV portfolio as its other prevention drug, Truvada, faces generic competition.<\/p>\n<p style=\"text-align: justify;\">We note that lenacapavir is already approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals.\u00a0 It is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, who are at risk of HIV acquisition.<\/p>\n<p style=\"text-align: justify;\">A long-acting injectable form of PrEP was also approved by the FDA. In 2021, the regulatory body approved ViiV Healthcare\u2019s Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV.<\/p>\n<p style=\"text-align: justify;\">ViiV Healthcare is a global specialist HIV company, majorly owned by <strong>GSK plc<\/strong> GSK, with Pfizer and Shionogi as shareholders. The company was formed by GSK and Pfizer in 2009.<\/p>\n<div class=\"ads__inline\">\n<div id=\"js-dfp-tag-BTk\"  class=\"btf-bodymidpagetwothirdswidth-5\">          <script type=\"text\/javascript\">         googletag.cmd.push(function() {             \/\/ Check if ID matches ID in the window.adsList array before calling googletag.display             function isAdInAdsList(id) {             for (var i = 0; i < window.adsList.length; i++) {                 if (window.adsList[i].id === id) {                     return true;                 }             }             return false;         }         if (isAdInAdsList('js-dfp-tag-BTk')) {             googletag.display('js-dfp-tag-BTk');         }         });     <\/script> <\/div>\n<\/p><\/div>\n<p style=\"text-align: justify;\">Apretude is given first as two initiation injections, administered a month apart and then every two months. Patients in need can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to understand how well they can tolerate the drug.<\/p>\n<p style=\"text-align: justify;\">Approval of better HIV treatments should strengthen GILD\u2019s HIV franchise in the wake of increasing competition from the likes of GSK.<\/p>\n<p style=\"text-align: justify;\">GSK\u2019s HIV portfolio sales are being driven by strong patient demand for Cabenuva, Apretude and Dovato.\u00a0 The company is also focused on the development of the next generation of HIV innovation with integrase inhibitors (INSTIs) for HIV treatment and prevention.<\/p>\n<h2>GILD\u2019s Zacks Rank and Stocks to Consider<\/h2>\n<p style=\"text-align: justify;\">Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the pharma\/biotech sector are <strong>Novartis<\/strong> NVS and <strong>Bayer <\/strong>BAYRY, both carrying a Zacks Rank #2 (Buy) at present. You can see <strong>the complete list of today\u2019s Zacks #1 Rank (Strong Buy) stocks here<\/strong>.<\/p>\n<p style=\"text-align: justify;\">The Zacks Consensus Estimate for Novartis\u2019 2025 earnings per share (EPS) has risen from $8.53 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 23 cents to $9.02 during this timeframe. The stock has risen 22% so far this year.<\/p>\n<div class=\"ads__inline\">\n<div id=\"js-dfp-tag-MEI\"  class=\"btf-bodymidpagetwothirdswidth-6\">          <script type=\"text\/javascript\">         googletag.cmd.push(function() {             \/\/ Check if ID matches ID in the window.adsList array before calling googletag.display             function isAdInAdsList(id) {             for (var i = 0; i < window.adsList.length; i++) {                 if (window.adsList[i].id === id) {                     return true;                 }             }             return false;         }         if (isAdInAdsList('js-dfp-tag-MEI')) {             googletag.display('js-dfp-tag-MEI');         }         });     <\/script> <\/div>\n<\/p><\/div>\n<p style=\"text-align: justify;\">BAYRY\u2019s 2025 EPS estimate has increased from $1.19 to $1.25 for 2025 over the past 60 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 59.8%.<\/p>\n<p style=\"text-align: justify;\">BAYRY\u2019s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.<\/p>\n<p>\u00a0<\/p>\n<\/p>\n<h2> \tOnly $1 to See All Zacks' Buys and Sells<\/h2>\n<p> \t<em>We're not kidding.<\/em><\/p>\n<p> \tSeveral years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent.<\/p>\n<p> \tThousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like\u00a0<em>Surprise Trader, Stocks Under $10, Technology Innovators,<\/em>and more, that closed 256 positions with double- and triple-digit gains in 2024 alone.<\/p>\n<div class=\"ads__inline\">\n<div id=\"js-dfp-tag-AQY\"  class=\"btf-bodymidpagetwothirdswidth-7\">          <script type=\"text\/javascript\">         googletag.cmd.push(function() {             \/\/ Check if ID matches ID in the window.adsList array before calling googletag.display             function isAdInAdsList(id) {             for (var i = 0; i < window.adsList.length; i++) {                 if (window.adsList[i].id === id) {                     return true;                 }             }             return false;         }         if (isAdInAdsList('js-dfp-tag-AQY')) {             googletag.display('js-dfp-tag-AQY');         }         });     <\/script> <\/div>\n<\/p><\/div>\n<p>   See Stocks Now >><\/p>\n<p>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report<\/p>\n<p>GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report<\/p>\n<p>Novartis AG (NVS) : Free Stock Analysis Report<\/p>\n<p>Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report<\/p>\n<p>Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report<\/p>\n<p>This article originally published on Zacks Investment Research (zacks.com).<\/p>\n<p>Zacks Investment Research<\/p>\n<\/p>\n<p class=\"body__disclaimer\">The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/section>\n<p>        <script type=\"text\/javascript\">   \/\/ add oddAd class to every odd instance of body .ads__inline for different placeholder styles   let articleAds = document.querySelectorAll('.ads__inline');   for (let i = 0, len = articleAds.length; i < len; i++) {     \/\/ Do the below only if the curent count is less than 12     if ((i < 12) &#038;&#038; (i % 2 === 0)) {       articleAds[i].className += ' oddAd';     }   } <\/script>                                               <\/p>\n<div class=\"jupiter22-c-tags jupiter22-c-tags-default\">\n<h3 class=\"jupiter22-c-tags-title\">         Tags       <\/h3>\n<div class=\"jupiter22-c-tags-container\">StocksInvesting<\/div>\n<\/p><\/div>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Gilead Sciences, Inc. GILD obtained FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV. The regulatory body approved lenacapavir, under the brand name Yeztugo, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. This groundbreaking injectable therapy marks [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":13008,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"","ocean_second_sidebar":"","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"","ocean_custom_header_template":"","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"","ocean_menu_typo_font_family":"","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"on","ocean_gallery_id":[],"footnotes":""},"categories":[18],"tags":[],"class_list":["post-13007","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-stock","entry","has-media"],"_links":{"self":[{"href":"https:\/\/sharewatch.com\/wp\/wp-json\/wp\/v2\/posts\/13007","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sharewatch.com\/wp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sharewatch.com\/wp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sharewatch.com\/wp\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sharewatch.com\/wp\/wp-json\/wp\/v2\/comments?post=13007"}],"version-history":[{"count":0,"href":"https:\/\/sharewatch.com\/wp\/wp-json\/wp\/v2\/posts\/13007\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sharewatch.com\/wp\/wp-json\/wp\/v2\/media\/13008"}],"wp:attachment":[{"href":"https:\/\/sharewatch.com\/wp\/wp-json\/wp\/v2\/media?parent=13007"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sharewatch.com\/wp\/wp-json\/wp\/v2\/categories?post=13007"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sharewatch.com\/wp\/wp-json\/wp\/v2\/tags?post=13007"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}