{"id":720624,"date":"2026-06-07T07:55:38","date_gmt":"2026-06-07T07:55:38","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/720624\/"},"modified":"2026-06-07T07:55:38","modified_gmt":"2026-06-07T07:55:38","slug":"regeneron-regn-says-ema-accepted-review-for-otarmeni-application","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/720624\/","title":{"rendered":"Regeneron (REGN) Says EMA Accepted Review for Otarmeni Application"},"content":{"rendered":"\n<p class=\"yf-1fy9kyt\">Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the <a href=\"https:\/\/www.insidermonkey.com\/blog\/10-best-debt-free-sp-500-stocks-to-buy-now-1770232\/\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:10 Best Debt-Free S&amp;P 500 Stocks to Buy Now;elm:context_link;itc:0;sec:content-canvas\" data-yga=\"{&quot;yLinkElement&quot;:&quot;context_link&quot;,&quot;yModuleName&quot;:&quot;content-canvas&quot;,&quot;yLinkText&quot;:&quot;10 Best Debt-Free S&amp;amp&quot;}\" class=\"link \">10 Best Debt-Free S&amp;P 500 Stocks to Buy Now<\/a>.<\/p>\n<p class=\"yf-1fy9kyt\">On May 22, 2026, Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced that the European Medicines Agency accepted for review under Accelerated Assessment the Marketing Authorization Application for Otarmeni, an in vivo adeno-associated virus vector-based gene therapy for biallelic OTOF variant-associated hearing loss. Otarmeni, formerly known as DB-OTO, previously received Orphan Designation from the EMA. If approved, Otarmeni would become the first gene therapy for OTOF-related hearing loss in the European Union. The application is supported by data from the pivotal CHORD trial, where 24 participants received a single dose of Otarmeni through intracochlear infusion.<\/p>\n<p class=\"yf-1fy9kyt\">On May 19, 2026, Canaccord analyst John Newman lowered the firm\u2019s price target on Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) to $875 from $1,057 and maintained a Buy rating on the shares. Newman updated the model after the Phase 3 study of fianlimab+cemiplimab versus pembrolizumab failed to hit statistical significance on the primary endpoint of progression-free survival, calling it a surprising and disappointing event.<\/p>\n<p>    <img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/www.newsbeep.com\/au\/wp-content\/uploads\/2026\/06\/bb9eeca959da429f530467dc58c79488.jpeg\" alt=\"Regeneron (REGN) Says EMA Accepted Review for Otarmeni Application\" loading=\"eager\" height=\"512\" width=\"768\" class=\"yf-lglytj  loaded\"\/> Regeneron (REGN) Says EMA Accepted Review for Otarmeni Application      <\/p>\n<p class=\"yf-1fy9kyt\">Wolfe Research analyst Alexandria Hammond also lowered the firm\u2019s price target on Regeneron to $860 from $900 and maintained an Outperform rating. Hammond said the company\u2019s LAG-3 trial missed its primary endpoint, while noting that commercial execution will be important and that second-half 2026 catalysts may be underappreciated.<\/p>\n<p class=\"yf-1fy9kyt\">Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) discovers, develops, manufactures, and commercializes medicines to treat various diseases worldwide.<\/p>\n<p class=\"yf-1fy9kyt\">While we acknowledge the potential of REGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you&#8217;re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the<a class=\"link \" href=\"https:\/\/www.insidermonkey.com\/blog\/three-megatrends-one-overlooked-stock-massive-upside-1548959\/\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:\u00a0best short-term AI stock;elm:context_link;itc:0;sec:content-canvas\" data-yga=\"{&quot;yLinkElement&quot;:&quot;context_link&quot;,&quot;yModuleName&quot;:&quot;content-canvas&quot;,&quot;yLinkText&quot;:&quot;&amp;nbsp&quot;}\">\u00a0best short-term AI stock<\/a>.<\/p>\n<p class=\"yf-1fy9kyt\">READ NEXT:\u00a0<a class=\"link \" href=\"https:\/\/www.insidermonkey.com\/blog\/33-stocks-that-should-double-in-3-years-1709437\/\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:33 Stocks That Should Double in 3 Years;elm:context_link;itc:0;sec:content-canvas\" data-yga=\"{&quot;yLinkElement&quot;:&quot;context_link&quot;,&quot;yModuleName&quot;:&quot;content-canvas&quot;,&quot;yLinkText&quot;:&quot;33 Stocks That Should Double in 3 Years&quot;}\">33 Stocks That Should Double in 3 Years<\/a> and <a class=\"link \" href=\"https:\/\/www.insidermonkey.com\/blog\/wp-admin\/post.php?post=1716175&amp;action=edit\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy;elm:context_link;itc:0;sec:content-canvas\" data-yga=\"{&quot;yLinkElement&quot;:&quot;context_link&quot;,&quot;yModuleName&quot;:&quot;content-canvas&quot;,&quot;yLinkText&quot;:&quot;Cathie Wood 2026 Portfolio&quot;}\">Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy<\/a>.\u00a0<\/p>\n<p class=\"yf-1fy9kyt\">Disclosure: None. <a class=\"link \" href=\"https:\/\/news.google.com\/publications\/CAAqLQgKIidDQklTRndnTWFoTUtFV2x1YzJsa1pYSnRiMjVyWlhrdVkyOXRLQUFQAQ?hl=en-US&amp;gl=US&amp;ceid=US%3Aen\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:Follow Insider Monkey on Google News;elm:context_link;itc:0;sec:content-canvas\" data-yga=\"{&quot;yLinkElement&quot;:&quot;context_link&quot;,&quot;yModuleName&quot;:&quot;content-canvas&quot;,&quot;yLinkText&quot;:&quot;Follow Insider Monkey on Google News&quot;}\">Follow Insider Monkey on Google News<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the 10 Best Debt-Free S&amp;P 500 Stocks to Buy Now. On&hellip;\n","protected":false},"author":2,"featured_media":720625,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[349353,64,63,190461,2588,5278,137,349352,349351,490,349350],"class_list":["post-720624","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-alexandria-hammond","tag-au","tag-australia","tag-european-medicines-agency","tag-european-union","tag-gene-therapy","tag-health","tag-john-newman","tag-marketing-authorization-application","tag-medication","tag-regeneron-pharmaceuticals"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/720624","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=720624"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/720624\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/720625"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=720624"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=720624"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=720624"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}