{"id":7139,"date":"2024-04-16T08:00:00","date_gmt":"2024-04-16T06:00:00","guid":{"rendered":"https:\/\/nanexa.com\/mfn_news\/godkannandet-av-klinisk-provningsansokan-for-nex-22-studien-forsenas\/"},"modified":"2024-04-16T08:00:00","modified_gmt":"2024-04-16T06:00:00","slug":"godkannandet-av-klinisk-provningsansokan-for-nex-22-studien-forsenas","status":"publish","type":"mfn_news","link":"https:\/\/nanexa.com\/sv\/mfn_news\/godkannandet-av-klinisk-provningsansokan-for-nex-22-studien-forsenas\/","title":{"rendered":"Godk\u00e4nnandet av klinisk pr\u00f6vningsans\u00f6kan f\u00f6r NEX-22-studien f\u00f6rsenas"},"content":{"rendered":"<div class=\"mfn-preamble\">\n<p><strong>Nanexa AB meddelar idag att i den p\u00e5g\u00e5ende granskningsprocessen av den kliniska pr\u00f6vningsans\u00f6kan f\u00f6r fas I-studien med NEX-22 har ytterligare kompletteringar efterfr\u00e5gats fr\u00e5n tyska l\u00e4kemedelsmyndigheten, vilket i den nya europeiska regulatoriska processen tar mer tid \u00e4n f\u00f6rv\u00e4ntat.<\/strong><\/p>\n<\/div>\n<div class=\"mfn-body\">\n<p>Nanexa utvecklar NEX-22, en en-m\u00e5nadsprodukt av GLP-1 substansen liraglutid, f\u00f6r behandling av typ-2 diabetes. I december 2023 skickade bolaget in kliniska pr\u00f6vningsans\u00f6kan f\u00f6r en f\u00f6rsta fas I-studie med NEX-22 och fick under f\u00f6rsta kvartalet 2024 besked om att vissa kompletteringar och f\u00f6rtydliganden av ans\u00f6kan efterfr\u00e5gades och merparten av dessa f\u00f6rtydliganden accepterades \u00e4ven av myndigheten under f\u00f6rsta kvartalet. Ett f\u00e5tal \u00e5terst\u00e5ende kompletteringar, hanterades skyndsamt av Nanexa men med det nya europeiska systemet f\u00f6r granskning av kliniska pr\u00f6vningar kr\u00e4vdes ett nytt inskick av ans\u00f6kan, vilket i sig har f\u00f6rsenat processen. Nanexa har nu erh\u00e5llit n\u00e5gra ytterligare fr\u00e5gor fr\u00e5n myndigheten utifr\u00e5n den nya granskningen av ans\u00f6kan. Bolaget ser inga sv\u00e5righeter att besvara dessa men ans\u00f6kan kommer med nuvarande tidslinje inte att godk\u00e4nnas under april.<\/p>\n<p>\u201dVi hade som m\u00e5ls\u00e4ttning att kunna starta studien under f\u00f6rsta kvartalet och \u00e4r f\u00f6rst\u00e5s besvikna p\u00e5 att godk\u00e4nnandeprocessen tar mer tid \u00e4n f\u00f6rv\u00e4ntat. B\u00e5de behovet att skicka in ans\u00f6kan p\u00e5 nytt och det faktum att nya fr\u00e5gor tillkommit orsakar f\u00f6rsening. Vi k\u00e4nner oss dock trygga i att vi kan hantera alla fr\u00e5gest\u00e4llningar och v\u00e5r bed\u00f6mning i dagsl\u00e4get \u00e4r att vi kan erh\u00e5lla godk\u00e4nnande och komma ig\u00e5ng med studien mot slutet av andra kvartalet. Med den tidplanen kommer vi fortfarande kunna erh\u00e5lla viktiga kliniska data innan \u00e5rsskiftet. I \u00f6vrigt \u00e4r vi s\u00e5 redo vi kan vara, det kliniska pr\u00f6vningsmaterialet \u00e4r tillverkat och v\u00e5r klinik \u00e4r redo att rekrytera patienter s\u00e5 snart vi har ett godk\u00e4nnande\u201d, s\u00e4ger David Westberg, vd f\u00f6r Nanexa.<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-contacts mfn-2376405b3437\">\n<p><strong class=\"mfn-heading-1\">F\u00f6r mer information kontakta:<\/strong><\/p>\n<hr \/>\n<p>David Westberg \u2013 VD, Nanexa AB (publ)\u00a0<br \/>Telefon: 0709-42 83 03<br \/>E-post:\u00a0<a href=\"mailto:david.westberg@nanexa.se\" rel=\"noopener\" target=\"_blank\">david.westberg@nanexa.se<\/a><br \/><a href=\"http:\/\/www.nanexa.com\" rel=\"noopener\" target=\"_blank\">www.nanexa.com<\/a><\/p>\n<p>Bolagets Certified Adviser \u00e4r Carnegie Investment Bank AB (publ).<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-about mfn-c9ba281e2dde\">\n<p><strong class=\"mfn-heading-1\">Om Nanexa AB (publ)<\/strong><\/p>\n<hr \/>\n<p>Nanexa \u00e4r ett l\u00e4kemedelsbolag som utvecklar injicerbara l\u00e4kemedel baserade p\u00e5 det patenterade och innovativa drug delivery-systemet PharmaShell\u00ae \u2013 ett system som m\u00f6jligg\u00f6r n\u00e4sta generations l\u00e5ngverkande injicerbara l\u00e4kemedel med h\u00f6g drug load, tillverkade med atomlagerprecision. Nanexa utvecklar egna produkter och har dessutom samarbetsavtal med flera l\u00e4kemedelsbolag, d\u00e4ribland Novo Nordisk och AstraZeneca.<\/p>\n<p>Nanexas aktie \u00e4r noterad p\u00e5 Nasdaq First North Growth Market i Stockholm (NANEXA).<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Bifogade filer<\/strong><\/p>\n<hr \/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/a1e96b83-e60b-496e-8589-3a18984a0211\/godkannandet-av-klinisk-provningsansokan-for-nex-22-studien-forsenas.pdf\" rel=\"noopener\" target=\"_blank\">Godk\u00e4nnandet av klinisk pr\u00f6vningsans\u00f6kan f\u00f6r NEX-22-studien f\u00f6rsenas<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Nanexa AB meddelar idag att i den p\u00e5g\u00e5ende granskningsprocessen av den kliniska pr\u00f6vningsans\u00f6kan f\u00f6r fas I-studien med NEX-22 har ytterligare kompletteringar efterfr\u00e5gats fr\u00e5n tyska l\u00e4kemedelsmyndigheten, vilket i den nya europeiska regulatoriska processen tar mer tid \u00e4n f\u00f6rv\u00e4ntat.<\/p>\n","protected":false},"template":"","class_list":["post-7139","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci_sv","mfn-news-tag-mfn-type-ir_sv","mfn-news-tag-mfn_sv","mfn-news-tag-mfn-ci-other_sv","mfn-news-tag-mfn-lang-sv_sv"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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