{"id":927669,"date":"2026-01-15T10:37:54","date_gmt":"2026-01-15T15:37:54","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\/"},"modified":"2026-01-15T10:37:54","modified_gmt":"2026-01-15T15:37:54","slug":"hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\/","title":{"rendered":"Hoth Therapeutics Reaches Key EU Regulatory Inflection Point Advancing HT-001 Oncology Trial Toward Multi-Country Site Activation"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<ul type=\"disc\">\n<li>Positive\u00a0EU regulatory conclusion achieved<\/li>\n<li>Oncology-focused clinical program<\/li>\n<li>Multi-country European trial footprint<\/li>\n<li>Clear line of sight to site activation and enrollment<\/li>\n<li>Near-term regulatory and operational catalysts<\/li>\n<\/ul>\n<p>\n        <b>Positive CTIS Conclusion Positions Company for Near-Term Clinical Trial Initiation in Cancer Patients<\/b>\n      <\/p>\n<p>\n        <span class=\"legendSpanClass\">NEW YORK<\/span>, <span class=\"legendSpanClass\">Jan. 15, 2026<\/span> \/PRNewswire\/ &#8212; <b>Hoth Therapeutics, Inc.<\/b><b>(NASDAQ: HOTH)<\/b>,\u00a0a clinical-stage biopharmaceutical company developing therapies for serious and underserved conditions, today announced it has achieved a major European regulatory milestone for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.html\" target=\"_blank\" rel=\"nofollow\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.jpg\" title=\"(PRNewsfoto\/Hoth Therapeutics Inc.)\" alt=\"(PRNewsfoto\/Hoth Therapeutics Inc.)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<p>The Company received a positive regulatory conclusion under the European Union Clinical Trials Information System (CTIS) for Part I. This determination confirms the scientific and regulatory acceptability of the trial design and investigational products.\u00a0Hoth expects to activate clinical trial sites and initiate the study across multiple European countries.<\/p>\n<p>In parallel, country-specific Part II regulatory decisions in Hungary, Spain, and Poland are expected by January 19, 2026, positioning the program for rapid, multi-national clinical execution.<\/p>\n<p>&#8220;This marks a meaningful regulatory inflection point for Hoth and our oncology-focused pipeline,&#8221; said Robb Knie at Hoth Therapeutics. &#8220;Regulators have confirmed the acceptability of our application for this cancer-related indication.&#8221;<\/p>\n<p>The HT-001 program is being developed to address EGFRI-induced dermatologic toxicities, a common and often dose-limiting complication experienced by cancer patients undergoing treatment. These side effects can negatively impact quality of life, disrupt treatment schedules, and increase overall healthcare burden.<\/p>\n<p>Hoth expects to activate sites, initiate patient enrollment, and advance the program into active clinical execution, representing a critical step toward validating a potential new supportive-care therapy for oncology patients.<\/p>\n<p>\n        <b>About Hoth Therapeutics, Inc.<br \/><\/b>Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit <a href=\"https:\/\/edge.prnewswire.com\/c\/link\/?t=0&amp;l=en&amp;o=4596542-1&amp;h=1500776155&amp;u=https%3A%2F%2Fir.hoththerapeutics.com%2F&amp;a=https%3A%2F%2Fir.hoththerapeutics.com%2F\" target=\"_blank\" rel=\"nofollow\">https:\/\/ir.hoththerapeutics.com\/<\/a>\u00a0.<\/p>\n<p>\n        <b>Forward-Looking Statement<br \/><\/b>This\u00a0press\u00a0release includes\u00a0forward-looking\u00a0statements\u00a0based\u00a0upon\u00a0Hoth&#8217;s current\u00a0expectations,\u00a0which\u00a0may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth&#8217;s business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates\u00a0and\u00a0any\u00a0other\u00a0product candidates\u00a0we\u00a0may\u00a0develop,\u00a0and\u00a0the\u00a0labeling under\u00a0any\u00a0approval we\u00a0may obtain;\u00a0the\u00a0timing\u00a0and\u00a0costs\u00a0of\u00a0clinical\u00a0trials, and\u00a0the\u00a0timing and\u00a0costs\u00a0of\u00a0other\u00a0expenses;\u00a0market\u00a0acceptance of\u00a0our\u00a0products;\u00a0the\u00a0ultimate\u00a0impact of\u00a0the\u00a0current\u00a0coronavirus\u00a0pandemic, or\u00a0any\u00a0other\u00a0health\u00a0epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management&#8217;s expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as &#8220;could,&#8221; &#8220;believe,&#8221; &#8220;anticipate,&#8221; &#8220;intend,&#8221; &#8220;estimate,&#8221; &#8220;expect,&#8221; &#8220;may,&#8221; &#8220;continue,&#8221; &#8220;predict,&#8221; &#8220;potential,&#8221; &#8220;project&#8221; or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled &#8220;Risk Factors&#8221; in\u00a0Hoth&#8217;s most recent Annual Report on Form 10-K and Hoth&#8217;s other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth&#8217;s current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.<\/p>\n<p>\n        <b>Investor Contact:<\/b><br \/>\n        <br \/>LR Advisors LLC<br \/>Email:\u00a0<a href=\"mailto:investorrelations@hoththerapeutics.com\" target=\"_blank\" rel=\"nofollow\">investorrelations@hoththerapeutics.com<\/a><br \/><a href=\"https:\/\/edge.prnewswire.com\/c\/link\/?t=0&amp;l=en&amp;o=4596542-1&amp;h=4168291025&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3041986-1%26h%3D537704384%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D2889507-1%2526h%253D1377821239%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D2823479-1%252526h%25253D536261162%252526u%25253Dhttp%2525253A%2525252F%2525252Fwww.hoththerapeutics.com%2525252F%252526a%25253Dwww.hoththerapeutics.com%2526a%253Dwww.hoththerapeutics.com%26a%3Dwww.hoththerapeutics.com&amp;a=www.hoththerapeutics.com\" target=\"_blank\" rel=\"nofollow\">www.hoththerapeutics.com<\/a><br \/>Phone:\u00a0(678) 570-6791<\/p>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/edge.prnewswire.com\/c\/img\/favicon.png?sn=NY64019&amp;sd=2026-01-15\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation-302661977.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation-302661977.html<\/a><\/p>\n<p>SOURCE Hoth Therapeutics, Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=NY64019&amp;Transmission_Id=202601150817PR_NEWS_USPR_____NY64019&amp;DateId=20260115\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire Positive\u00a0EU regulatory conclusion achieved Oncology-focused clinical program Multi-country European trial footprint Clear line of sight to site activation and enrollment Near-term regulatory and operational catalysts Positive CTIS Conclusion Positions Company for Near-Term Clinical Trial Initiation in Cancer Patients NEW YORK, Jan. 15, 2026 \/PRNewswire\/ &#8212; Hoth Therapeutics, Inc.(NASDAQ: HOTH),\u00a0a clinical-stage biopharmaceutical company developing therapies for serious and underserved conditions, today announced it has achieved a major European regulatory milestone for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies. The Company received a positive regulatory conclusion under the European Union Clinical Trials Information System (CTIS) for Part I. This determination confirms the scientific and regulatory acceptability of the trial design and investigational products.\u00a0Hoth expects to activate &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Hoth Therapeutics Reaches Key EU Regulatory Inflection Point Advancing HT-001 Oncology Trial Toward Multi-Country Site Activation&#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-927669","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Hoth Therapeutics Reaches Key EU Regulatory Inflection Point Advancing HT-001 Oncology Trial Toward Multi-Country Site Activation - 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\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hoth Therapeutics Reaches Key EU Regulatory Inflection Point Advancing HT-001 Oncology Trial Toward Multi-Country Site Activation - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire Positive\u00a0EU regulatory conclusion achieved Oncology-focused clinical program Multi-country European trial footprint Clear line of sight to site activation and enrollment Near-term regulatory and operational catalysts Positive CTIS Conclusion Positions Company for Near-Term Clinical Trial Initiation in Cancer Patients NEW YORK, Jan. 15, 2026 \/PRNewswire\/ &#8212; Hoth Therapeutics, Inc.(NASDAQ: HOTH),\u00a0a clinical-stage biopharmaceutical company developing therapies for serious and underserved conditions, today announced it has achieved a major European regulatory milestone for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies. The Company received a positive regulatory conclusion under the European Union Clinical Trials Information System (CTIS) for Part I. This determination confirms the scientific and regulatory acceptability of the trial design and investigational products.\u00a0Hoth expects to activate &hellip; Continue reading &quot;Hoth Therapeutics Reaches Key EU Regulatory Inflection Point Advancing HT-001 Oncology Trial Toward Multi-Country Site Activation&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-01-15T15:37:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.jpg\" \/>\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=\"4 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\\\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Hoth Therapeutics Reaches Key EU Regulatory Inflection Point Advancing HT-001 Oncology Trial Toward Multi-Country Site Activation\",\"datePublished\":\"2026-01-15T15:37:54+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\\\/\"},\"wordCount\":845,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/644804\\\/Hoth_Therapeutics_Logo.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-reaches-key-eu-regulatory-inflection-point-advancing-ht-001-oncology-trial-toward-multi-country-site-activation\\\/\",\"name\":\"Hoth Therapeutics Reaches Key EU Regulatory Inflection Point Advancing HT-001 Oncology Trial Toward Multi-Country Site Activation - 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The Company received a positive regulatory conclusion under the European Union Clinical Trials Information System (CTIS) for Part I. 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