{"id":295417,"date":"2026-07-03T16:07:12","date_gmt":"2026-07-03T16:07:12","guid":{"rendered":"https:\/\/www.europesays.com\/se\/295417\/"},"modified":"2026-07-03T16:07:12","modified_gmt":"2026-07-03T16:07:12","slug":"ascelia-pharma-faller-70-procent-efter-complete-response-letter-fran-fda-uppdatering","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/se\/295417\/","title":{"rendered":"Ascelia Pharma faller 70 procent efter Complete Response Letter fr\u00e5n FDA (uppdatering)"},"content":{"rendered":"<p class=\"font-sans text-base text-text-main dark:text-text-main-dark font-normal leading-[1.4]\">(uppdatering avser till\u00e4gg i hela nyheten)\n <\/p>\n<p>Forskningsbolaget Ascelia Pharma har f\u00e5tt ett s\u00e5 kallat Complete Response Letter fr\u00e5n den amerikanska l\u00e4kemedelsmyndigheten FDA avseende registreringsans\u00f6kan f\u00f6r Orviglance, enligt ett pressmeddelande.\n <\/p>\n<p>FDA godk\u00e4nner inte ans\u00f6kan i dess nuvarande form och beg\u00e4r ytterligare kliniska data samt kompletterande produktdokumentation.\n <\/p>\n<p>Bolaget planerar att beg\u00e4ra ett Typ A-m\u00f6te med FDA f\u00f6r att diskutera den fortsatta processen. Ascelia uppger att finansieringen r\u00e4cker in i 2027 och att kostnadsbesparande \u00e5tg\u00e4rder utv\u00e4rderas.\n <\/p>\n<p>&#8221;Vi har fortsatt en stark tilltro till Orviglance och \u00e4r fast beslutna att g\u00f6ra det tillg\u00e4ngligt f\u00f6r patienter&#8221;, s\u00e4ger vd Magnus Corfitzen.\n <\/p>\n<p>Aktien rasar cirka 70 procent.<br \/>\n <br class=\"col-start-2\"\/><\/p>\n<p class=\"font-sans text-base text-text-main dark:text-text-main-dark font-normal leading-[1.4]\">Leo Luthander<br \/>\n <br class=\"col-start-2\"\/><br \/>\n leo.luthander@finwire.se<br \/>\n <br class=\"col-start-2\"\/><br \/>\n Nyhetsbyr\u00e5n Finwire<\/p>\n","protected":false},"excerpt":{"rendered":"(uppdatering avser till\u00e4gg i hela nyheten) Forskningsbolaget Ascelia Pharma har f\u00e5tt ett s\u00e5 kallat Complete Response Letter fr\u00e5n&hellip;\n","protected":false},"author":2,"featured_media":295256,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[65],"tags":[27497,72,70,71,34,31,33,32,30],"class_list":["post-295417","post","type-post","status-publish","format-standard","has-post-thumbnail","category-ekonomi","tag-ascelia-pharma","tag-business","tag-economy","tag-ekonomi","tag-se","tag-svenska","tag-sverige","tag-sweden","tag-swedish"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@se\/116856910063267877","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/posts\/295417","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/comments?post=295417"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/posts\/295417\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/media\/295256"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/media?parent=295417"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/categories?post=295417"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/tags?post=295417"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}