{"id":925238,"date":"2026-01-08T07:04:56","date_gmt":"2026-01-08T12:04:56","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\/"},"modified":"2026-01-08T07:04:56","modified_gmt":"2026-01-08T12:04:56","slug":"amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\/","title":{"rendered":"Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A\/S"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A\/S<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li><i>AMX0318 selected as development candidate after meeting key criteria, demonstrating a robust chemical stability profile, strong <\/i>in vitro<i> potency, evidence of <\/i>in vivo<i> efficacy and tolerability, high solubility, and a favorable pharmacokinetic profile consistent with a long-acting peptide\n<p><\/i><\/li>\n<li><i>IND-enabling studies expected to initiate in 2026 with an IND targeted for 2027, pending successful completion of IND-enabling studies<\/i><\/li>\n<\/ul>\n<p>CAMBRIDGE, Mass.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.amylyx.com%2F&amp;esheet=54391562&amp;newsitemid=20260108102624&amp;lan=en-US&amp;anchor=Amylyx+Pharmaceuticals%2C+Inc.&amp;index=1&amp;md5=12c26d855ecedcf30a39dc787a14ea3c\">Amylyx Pharmaceuticals, Inc.<\/a> (NASDAQ: AMLX) (\u201cAmylyx\u201d or the \u201cCompany\u201d) today announced the selection of AMX0318, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia (PBH) and other rare diseases. AMX0318 was identified through a research collaboration with Gubra A\/S (\u201cGubra\u201d), a company specializing in peptide-based drug discovery and preclinical contract research services.<\/p>\n<p>\n\u201cWe are very pleased to nominate AMX0318 as a development candidate and were highly impressed by Gubra\u2019s proprietary and innovative process, which identified a peptide that surpassed our research target profile for a long-acting GLP-1 receptor antagonist. AMX0318 has thus far shown robust preclinical and chemical properties, including a pharmacokinetic profile that may support long-acting administration,\u201d said Camille L. Bedrosian, MD, Chief Medical Officer at Amylyx. \u201cWe are excited about the opportunity to develop additional therapeutic possibilities for people who may benefit from inhibiting GLP-1 receptor activity, including people with PBH and other rare diseases. The GLP-1 receptor is a well-characterized biological target and one of the key regulators of glucose-insulin homeostasis.\u201d<\/p>\n<p>\nDr. Bedrosian continued, \u201cWe have strong conviction that inhibiting GLP-1 receptor activity represents an important therapeutic approach given the statistically significant data that avexitide, our investigational, first-in-class GLP-1 receptor antagonist, has generated to date. We continue to expect completion of recruitment in our pivotal Phase 3 LUCIDITY trial of avexitide in Q1 2026, with topline data expected in Q3 2026.\u201d<\/p>\n<p>\nAMX0318 has completed extensive preclinical evaluation, including stability, solubility, potency,<i> in vivo<\/i> pharmacokinetics and pharmacodynamics, and <i>in vivo<\/i> tolerability studies. Amylyx expects the program to advance into investigational new drug (IND)-enabling studies later this year, with an IND targeted for 2027, pending successful completion of IND-enabling studies.<\/p>\n<p>\n\u201cWe are pleased to see AMX0318 advance as a development candidate, a milestone that reflects both the strong collaboration between the Gubra and Amylyx teams and the capabilities of Gubra\u2019s proprietary peptide drug discovery platform,\u201d said Louise S. Dalb\u00f8ge, Chief Science Officer at Gubra. \u201cOur AI-driven streaMLine platform enables multi-parameter optimization of peptide candidates, and we are excited to see this applied successfully to AMX0318 in close collaboration with Amylyx.\u201d<\/p>\n<p>\nUnder the terms of the research collaboration, Gubra is eligible to receive more than $50 million in success-based development and commercialization milestones plus mid-single digit royalties on worldwide net sales. The selection and handover of the development candidate will provide milestone payments of $4 million to Gubra.<\/p>\n<p><b>About Gubra<\/b><\/p>\n<p>\nGubra, founded in 2008 in Denmark and listed on NASDAQ Copenhagen, is a disease-agnostic techbio company specialized in peptide-based drug discovery and preclinical contract research services. Gubra\u2019s activities are focused on the early stages of drug development and are organized in two main business units \u2013 Biotech (D&amp;P) and CRO services. The two business areas are highly synergistic and create a unique entity capable of generating a steady cash flow from the CRO business while investing in high-impact biotech R&amp;D projects with significant value inflection potential through partnerships. Gubra has around 300 employees and had revenue of DKK 2.6 billion (around EUR 350 million) in the first 9 months of 2025. See <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.gubra.dk%2F&amp;esheet=54391562&amp;newsitemid=20260108102624&amp;lan=en-US&amp;anchor=www.gubra.dk&amp;index=2&amp;md5=d84256e7c017edb806c7ef752122322b\">www.gubra.dk<\/a> for more information.<\/p>\n<p><b>About Amylyx Pharmaceuticals<\/b><\/p>\n<p>\nAt Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are currently focused on four investigational therapies across several neurodegenerative and endocrine diseases in which we believe they can make the greatest impact. For more information, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.amylyx.com%2F&amp;esheet=54391562&amp;newsitemid=20260108102624&amp;lan=en-US&amp;anchor=amylyx.com&amp;index=3&amp;md5=89defc63505094f9807eab68726093a8\">amylyx.com<\/a> and follow us on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Famylyx%2F&amp;esheet=54391562&amp;newsitemid=20260108102624&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=4&amp;md5=d821bb06fa4fd499c2061dda7bbcef98\">LinkedIn<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2Famylyxpharma&amp;esheet=54391562&amp;newsitemid=20260108102624&amp;lan=en-US&amp;anchor=X&amp;index=5&amp;md5=7a6fa71b23faa73065b26444e255f158\">X<\/a>. For investors, please visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Finvestors.amylyx.com%2F&amp;esheet=54391562&amp;newsitemid=20260108102624&amp;lan=en-US&amp;anchor=investors.amylyx.com&amp;index=6&amp;md5=1f48c8b70937f68d38e4530e13d1f526\">investors.amylyx.com<\/a>.<\/p>\n<p><b>Amylyx Forward-Looking Statements<\/b><\/p>\n<p>\nStatements contained in this press release regarding matters that are not historical facts are \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx\u2019 expectations regarding: the therapeutic potential for AMX0318, the expected timeline for the IND-enabling studies and IND submission for AMX0318, the payments and royalties to be received by Gubra, and the expected timeline for certain development, regulatory, and commercial milestones. Any forward-looking statements in this press release are based on management\u2019s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx\u2019 program development activities; Amylyx\u2019 ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; the risk that early-stage results may not reflect later-stage results; Amylyx\u2019 ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx\u2019 operations, as well as the risks and uncertainties set forth in Amylyx\u2019 United States Securities and Exchange Commission (SEC) filings, including Amylyx\u2019 Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260108102624r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20260108102624\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260108102624\/en\/<\/a><\/span><\/p>\n<p><b>Gubra Media<br \/>\n<br \/><\/b>Sofia Pitt Boserup<br \/>\n<br \/>+45 4188 9586<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:sbo@gubra.dk\">sbo@gubra.dk<br \/>\n<\/a><b><\/p>\n<p>Gubra Investors<br \/>\n<br \/><\/b>Kristian Borbos<br \/>\n<br \/>+45 3080 8035<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:kbo@gubra.dk\">kbo@gubra.dk<br \/>\n<\/a><b><\/p>\n<p><\/b>Emma Jappe Lange<br \/>\n<b><br \/><\/b>+45 5361 6755<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:ejl@gubra.dk\">ejl@gubra.dk<br \/>\n<\/a><b><\/p>\n<p>Amylyx Media<br \/>\n<br \/><\/b>Amylyx Media Team<br \/>\n<br \/>(857) 320-6191<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:amylyxmediateam@amylyx.com\">amylyxmediateam@amylyx.com<br \/>\n<\/a><b><\/p>\n<p>Amylyx Investors<br \/>\n<br \/><\/b>Lindsey Allen<br \/>\n<br \/>(857) 320-6244<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:Investors@amylyx.com\">Investors@amylyx.com<\/a><\/p>\n<p><b>\u00a0<\/b><\/p>\n<p><b>KEYWORDS:<\/b> Massachusetts United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Biotechnology Pharmaceutical Managed Care Surgery Health Fitness &amp; Nutrition Clinical Trials Other Health<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260108102624\/en\/2180013\/3\/13268_Amylyx_logo_notagline-Color.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A\/S AMX0318 selected as development candidate after meeting key criteria, demonstrating a robust chemical stability profile, strong in vitro potency, evidence of in vivo efficacy and tolerability, high solubility, and a favorable pharmacokinetic profile consistent with a long-acting peptide IND-enabling studies expected to initiate in 2026 with an IND targeted for 2027, pending successful completion of IND-enabling studies CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211;Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (\u201cAmylyx\u201d or the \u201cCompany\u201d) today announced the selection of AMX0318, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia (PBH) and other rare diseases. AMX0318 was identified through a research &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A\/S&#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-925238","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>Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A\/S - 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\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A\/S - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A\/S AMX0318 selected as development candidate after meeting key criteria, demonstrating a robust chemical stability profile, strong in vitro potency, evidence of in vivo efficacy and tolerability, high solubility, and a favorable pharmacokinetic profile consistent with a long-acting peptide IND-enabling studies expected to initiate in 2026 with an IND targeted for 2027, pending successful completion of IND-enabling studies CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211;Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (\u201cAmylyx\u201d or the \u201cCompany\u201d) today announced the selection of AMX0318, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia (PBH) and other rare diseases. AMX0318 was identified through a research &hellip; Continue reading &quot;Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A\/S&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-01-08T12:04:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260108102624r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\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=\"5 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\\\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A\\\/S\",\"datePublished\":\"2026-01-08T12:04:56+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\\\/\"},\"wordCount\":1093,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20260108102624r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/amylyx-pharmaceuticals-announces-nomination-of-amx0318-as-a-novel-long-acting-glp-1-receptor-antagonist-development-candidate-identified-in-collaboration-with-gubra-a-s\\\/\",\"name\":\"Amylyx Pharmaceuticals Announces Nomination of AMX0318 as a Novel, Long-Acting GLP-1 Receptor Antagonist Development Candidate, Identified in Collaboration with Gubra A\\\/S - 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(NASDAQ: AMLX) (\u201cAmylyx\u201d or the \u201cCompany\u201d) today announced the selection of AMX0318, a long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist, as a development candidate for post-bariatric hypoglycemia (PBH) and other rare diseases. 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