{"id":60684,"date":"2025-01-27T07:02:33","date_gmt":"2025-01-27T06:02:33","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/"},"modified":"2025-01-27T07:02:33","modified_gmt":"2025-01-27T06:02:33","slug":"corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/","title":{"rendered":"Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray"},"content":{"rendered":"
\n

\nPDUFA Target Action Date Set for September 14, 2025<\/b><\/p>\n

<\/a>
<\/a><\/p>\n

HENDERSON, Nev.–(BUSINESS WIRE)–#corstasistherapeutics<\/a>–Corstasis Therapeutics Inc. (www.corstasis.com<\/a>), a clinical-stage MedTech pharmaceutical company developing innovative, practical therapies for fluid overload, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its novel Bumetanide Nasal Spray (RSQ-777). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 14, 2025<\/b>.<\/p>\n

\nThis NDA acceptance represents a pivotal milestone for Corstasis Therapeutics, signifying the FDA\u2019s determination that the application is sufficiently complete to move forward with a comprehensive review. Bumetanide Nasal Spray (RSQ-777) is being developed as a convenient, outpatient-focused therapy for edema associated with congestive heart failure, as well as liver and kidney disease.<\/p>\n

\n\u201cWe are pleased the FDA has accepted our NDA for Bumetanide Nasal Spray,\u201d said Benjamin Esque, CEO of Corstasis Therapeutics Inc.<\/b> \u201cThis milestone brings us closer to providing a simple, easy-to-use outpatient therapy for patients with fluid overload. We look forward to working closely with the FDA throughout the review process.\u201d<\/p>\n

\n\u201cOur aim is to reduce the burden on both patients and the healthcare system by offering treatment options outside the hospital setting\u2014potentially lowering costs and improving quality of life,\u201d added Dr. Brian Kolski, Chief Medical Officer of Corstasis Therapeutics Inc.<\/b><\/p>\n

\nAbout Bumetanide Nasal Spray<\/b><\/p>\n

\nBumetanide Nasal Spray is an investigational new drug designed to enable patients to self-administer non-oral loop diuretic therapy through the nasal mucosa in an outpatient setting.<\/p>\n

\nAbout Corstasis Therapeutics Inc.<\/b><\/p>\n

\nCorstasis Therapeutics Inc. is a clinical-stage MedTech pharmaceutical company focused on maximizing the potential of proven therapeutics. Our mission is to develop and deliver pragmatic, innovative therapies that enhance patient care and reduce healthcare costs. For more information, please visit www.corstasis.com<\/a>.
\n
#homeiswheretheheartis<\/p>\n

\nForward-Looking Statements<\/b><\/p>\n

\nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the development, regulatory progress, and potential benefits of Bumetanide Nasal Spray. These statements involve risks and uncertainties, such as the possibility that the FDA may not approve Bumetanide Nasal Spray by the expected date\u2014or at all\u2014and that additional data or analyses may be required. Actual results may differ materially from those expressed or implied by these forward-looking statements. Corstasis Therapeutics Inc. disclaims any obligation to update these statements except as required by law.<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia Contact<\/b>
Ben Esque, CEO
\n
Corstasis Therapeutics Inc.
\n
Phone: 702-541-9222
\n
Email: Info@corstasis.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

PDUFA Target Action Date Set for September 14, 2025 HENDERSON, Nev.–(BUSINESS WIRE)–#corstasistherapeutics–Corstasis Therapeutics Inc. (www.corstasis.com), a clinical-stage MedTech pharmaceutical company developing innovative, practical therapies for fluid overload, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its novel Bumetanide Nasal Spray (RSQ-777). The FDA … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-60684","6":"format-standard","7":"category-industry"},"yoast_head":"\nCorstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"PDUFA Target Action Date Set for September 14, 2025 HENDERSON, Nev.–(BUSINESS WIRE)–#corstasistherapeutics–Corstasis Therapeutics Inc. (www.corstasis.com), a clinical-stage MedTech pharmaceutical company developing innovative, practical therapies for fluid overload, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its novel Bumetanide Nasal Spray (RSQ-777). The FDA ... [Read more...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Trend\" \/>\n<meta property=\"article:published_time\" content=\"2025-01-27T06:02:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mms.businesswire.com\/media\/20250126982238\/en\/2362855\/22\/Corstasis_Logo_Color_072324%2C_VERTICAL.jpg\" \/>\n<meta name=\"author\" content=\"Business Wire\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Business Wire\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/\"},\"author\":{\"name\":\"Business Wire\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\"},\"headline\":\"Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray\",\"datePublished\":\"2025-01-27T06:02:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/\"},\"wordCount\":426,\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20250126982238\\\/en\\\/2362855\\\/22\\\/Corstasis_Logo_Color_072324%2C_VERTICAL.jpg\",\"articleSection\":[\"Industry\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/\",\"name\":\"Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray - Pharma Trend\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20250126982238\\\/en\\\/2362855\\\/22\\\/Corstasis_Logo_Color_072324%2C_VERTICAL.jpg\",\"datePublished\":\"2025-01-27T06:02:33+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/#primaryimage\",\"url\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20250126982238\\\/en\\\/2362855\\\/22\\\/Corstasis_Logo_Color_072324%2C_VERTICAL.jpg\",\"contentUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20250126982238\\\/en\\\/2362855\\\/22\\\/Corstasis_Logo_Color_072324%2C_VERTICAL.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\",\"name\":\"Pharma Trend\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\",\"name\":\"Pharma Trend\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"Pharma Trend\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\",\"name\":\"Business Wire\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray - Pharma Trend","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/","og_locale":"en_US","og_type":"article","og_title":"Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray - Pharma Trend","og_description":"PDUFA Target Action Date Set for September 14, 2025 HENDERSON, Nev.–(BUSINESS WIRE)–#corstasistherapeutics–Corstasis Therapeutics Inc. (www.corstasis.com), a clinical-stage MedTech pharmaceutical company developing innovative, practical therapies for fluid overload, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its novel Bumetanide Nasal Spray (RSQ-777). The FDA ... [Read more...]","og_url":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/","og_site_name":"Pharma Trend","article_published_time":"2025-01-27T06:02:33+00:00","og_image":[{"url":"https:\/\/mms.businesswire.com\/media\/20250126982238\/en\/2362855\/22\/Corstasis_Logo_Color_072324%2C_VERTICAL.jpg","type":"","width":"","height":""}],"author":"Business Wire","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Business Wire","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/#article","isPartOf":{"@id":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/"},"author":{"name":"Business Wire","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/person\/02d41342c7a74fa7f0032bb35ef0bb24"},"headline":"Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray","datePublished":"2025-01-27T06:02:33+00:00","mainEntityOfPage":{"@id":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/"},"wordCount":426,"publisher":{"@id":"https:\/\/pharma-trend.com\/en\/#organization"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/#primaryimage"},"thumbnailUrl":"https:\/\/mms.businesswire.com\/media\/20250126982238\/en\/2362855\/22\/Corstasis_Logo_Color_072324%2C_VERTICAL.jpg","articleSection":["Industry"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/","url":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/","name":"Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray - Pharma Trend","isPartOf":{"@id":"https:\/\/pharma-trend.com\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/#primaryimage"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/#primaryimage"},"thumbnailUrl":"https:\/\/mms.businesswire.com\/media\/20250126982238\/en\/2362855\/22\/Corstasis_Logo_Color_072324%2C_VERTICAL.jpg","datePublished":"2025-01-27T06:02:33+00:00","breadcrumb":{"@id":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/#primaryimage","url":"https:\/\/mms.businesswire.com\/media\/20250126982238\/en\/2362855\/22\/Corstasis_Logo_Color_072324%2C_VERTICAL.jpg","contentUrl":"https:\/\/mms.businesswire.com\/media\/20250126982238\/en\/2362855\/22\/Corstasis_Logo_Color_072324%2C_VERTICAL.jpg"},{"@type":"BreadcrumbList","@id":"https:\/\/pharma-trend.com\/en\/corstasis-therapeutics-inc-announces-fda-acceptance-of-new-drug-application-for-bumetanide-nasal-spray\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/pharma-trend.com\/en\/"},{"@type":"ListItem","position":2,"name":"Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray"}]},{"@type":"WebSite","@id":"https:\/\/pharma-trend.com\/en\/#website","url":"https:\/\/pharma-trend.com\/en\/","name":"Pharma Trend","description":"","publisher":{"@id":"https:\/\/pharma-trend.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/pharma-trend.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/pharma-trend.com\/en\/#organization","name":"Pharma Trend","url":"https:\/\/pharma-trend.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"Pharma Trend"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/person\/02d41342c7a74fa7f0032bb35ef0bb24","name":"Business Wire"}]}},"_links":{"self":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts\/60684","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/comments?post=60684"}],"version-history":[{"count":0,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts\/60684\/revisions"}],"wp:attachment":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/media?parent=60684"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/categories?post=60684"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/tags?post=60684"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}