{"id":2738,"date":"2026-06-26T19:59:00","date_gmt":"2026-06-26T19:59:00","guid":{"rendered":"https:\/\/cielcharlotte.com\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/"},"modified":"2026-06-26T19:59:00","modified_gmt":"2026-06-26T19:59:00","slug":"sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase","status":"publish","type":"post","link":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/","title":{"rendered":"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)"},"content":{"rendered":"

STOCKHOLM, June 26, 2026 \/PRNewswire\/ –The FDA has requested additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities; no clinical safety or efficacy concerns were identified that impact approvability Sobi to meet with FDA\u2026<\/p>\n

Read the full release \u2192<\/a><\/p>\n

News provided by PR Newswire.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

STOCKHOLM, June 26, 2026 \/PRNewswire\/ –The FDA has requested additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities; no clinical safety or efficacy concerns were identified that impact approvability Sobi to meet with FDA\u2026<\/p>\n","protected":false},"author":14,"featured_media":2740,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-2738","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-art-community"],"yoast_head":"\nSobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase) - Ciel Charlotte<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase) - Ciel Charlotte\" \/>\n<meta property=\"og:description\" content=\"STOCKHOLM, June 26, 2026 \/PRNewswire\/ --The FDA has requested additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities; no clinical safety or efficacy concerns were identified that impact approvability Sobi to meet with FDA\u2026\" \/>\n<meta property=\"og:url\" content=\"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/\" \/>\n<meta property=\"og:site_name\" content=\"Ciel Charlotte\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-26T19:59:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/development.brstdev.com\/cielcharlotte\/wp-content\/uploads\/2026\/09\/default-image.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"384\" \/>\n\t<meta property=\"og:image:height\" content=\"253\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ethan Parker\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ethan Parker\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/\"},\"author\":{\"name\":\"Ethan Parker\",\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/#\\\/schema\\\/person\\\/4c5e38434c81d2ebb9c5787b29251450\"},\"headline\":\"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)\",\"datePublished\":\"2026-06-26T19:59:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/\"},\"wordCount\":58,\"image\":{\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase-ai.png\",\"articleSection\":[\"Art Community\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/\",\"url\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/\",\"name\":\"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase) - Ciel Charlotte\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase-ai.png\",\"datePublished\":\"2026-06-26T19:59:00+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/#\\\/schema\\\/person\\\/4c5e38434c81d2ebb9c5787b29251450\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/#primaryimage\",\"url\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase-ai.png\",\"contentUrl\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase-ai.png\",\"width\":1536,\"height\":1024,\"caption\":\"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/#website\",\"url\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/\",\"name\":\"Ciel Charlotte\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/#\\\/schema\\\/person\\\/4c5e38434c81d2ebb9c5787b29251450\",\"name\":\"Ethan Parker\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/wp-content\\\/uploads\\\/2026\\\/09\\\/ethan-parkar-96x96.jpeg\",\"url\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/wp-content\\\/uploads\\\/2026\\\/09\\\/ethan-parkar-96x96.jpeg\",\"contentUrl\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/wp-content\\\/uploads\\\/2026\\\/09\\\/ethan-parkar-96x96.jpeg\",\"caption\":\"Ethan Parker\"},\"description\":\"Ethan Parker covers stories about community life, personal well-being, local initiatives, lifestyle trends, and the people working to create stronger communities. His writing looks for the human element behind larger developments, focusing on practical ideas and meaningful stories. Ethan brings an approachable perspective to subjects involving everyday life, community participation, creativity, and social connection.\",\"url\":\"https:\\\/\\\/development.brstdev.com\\\/cielcharlotte\\\/author\\\/ethan-parker\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase) - Ciel Charlotte","robots":{"index":"noindex","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"og_locale":"en_US","og_type":"article","og_title":"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase) - Ciel Charlotte","og_description":"STOCKHOLM, June 26, 2026 \/PRNewswire\/ --The FDA has requested additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities; no clinical safety or efficacy concerns were identified that impact approvability Sobi to meet with FDA\u2026","og_url":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/","og_site_name":"Ciel Charlotte","article_published_time":"2026-06-26T19:59:00+00:00","og_image":[{"width":384,"height":253,"url":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-content\/uploads\/2026\/09\/default-image.jpg","type":"image\/jpeg"}],"author":"Ethan Parker","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Ethan Parker"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/#article","isPartOf":{"@id":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/"},"author":{"name":"Ethan Parker","@id":"https:\/\/development.brstdev.com\/cielcharlotte\/#\/schema\/person\/4c5e38434c81d2ebb9c5787b29251450"},"headline":"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)","datePublished":"2026-06-26T19:59:00+00:00","mainEntityOfPage":{"@id":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/"},"wordCount":58,"image":{"@id":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/#primaryimage"},"thumbnailUrl":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-content\/uploads\/2026\/06\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase-ai.png","articleSection":["Art Community"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/","url":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/","name":"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase) - Ciel Charlotte","isPartOf":{"@id":"https:\/\/development.brstdev.com\/cielcharlotte\/#website"},"primaryImageOfPage":{"@id":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/#primaryimage"},"image":{"@id":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/#primaryimage"},"thumbnailUrl":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-content\/uploads\/2026\/06\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase-ai.png","datePublished":"2026-06-26T19:59:00+00:00","author":{"@id":"https:\/\/development.brstdev.com\/cielcharlotte\/#\/schema\/person\/4c5e38434c81d2ebb9c5787b29251450"},"breadcrumb":{"@id":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/#primaryimage","url":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-content\/uploads\/2026\/06\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase-ai.png","contentUrl":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-content\/uploads\/2026\/06\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase-ai.png","width":1536,"height":1024,"caption":"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)"},{"@type":"BreadcrumbList","@id":"https:\/\/development.brstdev.com\/cielcharlotte\/sobi-receives-complete-response-letter-from-fda-for-nasp-nanoencapsulated-sirolimus-plus-pegadricase\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/development.brstdev.com\/cielcharlotte\/"},{"@type":"ListItem","position":2,"name":"Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)"}]},{"@type":"WebSite","@id":"https:\/\/development.brstdev.com\/cielcharlotte\/#website","url":"https:\/\/development.brstdev.com\/cielcharlotte\/","name":"Ciel Charlotte","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/development.brstdev.com\/cielcharlotte\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/development.brstdev.com\/cielcharlotte\/#\/schema\/person\/4c5e38434c81d2ebb9c5787b29251450","name":"Ethan Parker","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-content\/uploads\/2026\/09\/ethan-parkar-96x96.jpeg","url":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-content\/uploads\/2026\/09\/ethan-parkar-96x96.jpeg","contentUrl":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-content\/uploads\/2026\/09\/ethan-parkar-96x96.jpeg","caption":"Ethan Parker"},"description":"Ethan Parker covers stories about community life, personal well-being, local initiatives, lifestyle trends, and the people working to create stronger communities. His writing looks for the human element behind larger developments, focusing on practical ideas and meaningful stories. Ethan brings an approachable perspective to subjects involving everyday life, community participation, creativity, and social connection.","url":"https:\/\/development.brstdev.com\/cielcharlotte\/author\/ethan-parker\/"}]}},"_links":{"self":[{"href":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-json\/wp\/v2\/posts\/2738","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-json\/wp\/v2\/users\/14"}],"replies":[{"embeddable":true,"href":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-json\/wp\/v2\/comments?post=2738"}],"version-history":[{"count":0,"href":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-json\/wp\/v2\/posts\/2738\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-json\/wp\/v2\/media\/2740"}],"wp:attachment":[{"href":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-json\/wp\/v2\/media?parent=2738"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-json\/wp\/v2\/categories?post=2738"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/development.brstdev.com\/cielcharlotte\/wp-json\/wp\/v2\/tags?post=2738"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}