{"id":761195,"date":"2023-06-01T08:35:43","date_gmt":"2023-06-01T12:35:43","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/arcturus-therapeutics-receives-u-s-fda-fast-track-designation-forarct-810-mrna-therapeutic-candidate-for-ornithine-transcarbamylase-deficiency\/"},"modified":"2023-06-01T08:35:43","modified_gmt":"2023-06-01T12:35:43","slug":"arcturus-therapeutics-receives-u-s-fda-fast-track-designation-forarct-810-mrna-therapeutic-candidate-for-ornithine-transcarbamylase-deficiency","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/arcturus-therapeutics-receives-u-s-fda-fast-track-designation-forarct-810-mrna-therapeutic-candidate-for-ornithine-transcarbamylase-deficiency\/","title":{"rendered":"Arcturus Therapeutics Receives U.S. FDA Fast Track Designation forARCT-810, mRNA Therapeutic Candidate for Ornithine Transcarbamylase Deficiency"},"content":{"rendered":"

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Arcturus Therapeutics Receives U.S. FDA Fast Track Designation for<\/b>ARCT-810, mRNA Therapeutic Candidate for Ornithine Transcarbamylase Deficiency<\/b><\/p>\n

SAN DIEGO–(BUSINESS WIRE<\/a>)–
\nArcturus Therapeutics Holdings Inc. (the \u201cCompany\u201d, \u201cArcturus\u201d, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the Company\u2019s mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency.<\/p>\n

\nFast Track Designation is designed to facilitate development and expedite review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address important unmet medical needs. Programs granted Fast Track Designation may receive important benefits including more frequent interactions with FDA review teams and the ability to obtain rolling review of a Biologics License Application (BLA). In addition, BLA applications may receive a priority review, with the FDA aiming to complete its review within six months, instead of the standard ten months review timeline.<\/p>\n

\n\u201cARCT-810 has the potential to be an important new medicine for individuals living with OTC deficiency and we are very pleased to have obtained Fast Track Designation for this program. This FDA designation provides several meaningful benefits that we expect will accelerate development and, hopefully, support the approval of this investigational therapy,\u201d said Juergen Froehlich, MD, MBA, FCP, Chief Medical Officer, of Arcturus Therapeutics. \u201cWe look forward to more frequent interactions with the FDA and to acceleration of ARCT 810 as a potential new treatment option that addresses the root cause of OTC deficiency.\u201d<\/p>\n

About Ornithine Transcarbamylase (OTC) Deficiency<\/b><\/p>\n

\nOTC deficiency is a serious urea cycle disorder with a prevalence of approximately 10,000 people worldwide. A lack of OTC, a critical urea cycle enzyme in liver cells, results in high blood ammonia levels that can cause diminished cognitive ability, seizures, coma and death. The current standard of care for OTC-deficient patients is a low-protein diet, nutritional supplements and ammonia scavengers to help prevent the accumulation of ammonia. These treatments do not address the underlying cause of OTC deficiency, for which there are no FDA approved medicines.<\/p>\n

About ARCT-810<\/b><\/p>\n

\nARCT-810 is a development candidate that represents a novel approach to treat ornithine transcarbamylase deficiency. ARCT-810 utilizes Arcturus\u2019 mRNA design construct and proprietary manufacturing process. ARCT-810 was developed using Arcturus\u2019 extensive and proprietary lipid library and employs its LUNAR\u00ae platform to deliver OTC mRNA to hepatocytes. ARCT-810 is an investigational mRNA medicine designed to enable OTC-deficient patients to naturally produce functional OTC enzyme in their own liver cells. Enabling patients to produce their own OTC enzyme has the potential to restore urea cycle activity, reduce the risk of metabolic decompensation, and improve quality of life.<\/p>\n

About Arcturus Therapeutics<\/b><\/p>\n

\nFounded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR\u00ae lipid-mediated delivery, (ii) STARR\u2122 mRNA Technology (samRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus\u2019 pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase deficiency and cystic fibrosis, along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus\u2019 versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus\u2019 technologies are covered by its extensive patent portfolio (patents and patent applications issued in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com<\/a>. In addition, please connect with us on Twitter<\/a> and LinkedIn<\/a>.<\/p>\n

Forward Looking Statements<\/b><\/p>\n

\nThis press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, the likelihood of success of the Company\u2019s pipeline (including ARCT-810) and partnered programs, the potential for the Company\u2019s platform to result in novel vaccines or therapeutics, the benefits that the Company might receive from Fast Track Designation for ARCT-810, continued or accelerated development of ARCT-810, likelihood of approval of ARCT-810 or its potential for therapeutic benefit including restoration of urea cycle activity, and the impact of general business and economic conditions. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry\u2019s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading “Risk Factors” in Arcturus\u2019 most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the SEC, which are available on the SEC\u2019s website at www.sec.gov<\/a>. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.<\/p>\n

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View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20230601005518\/en\/<\/a><\/span><\/p>\n

IR and Media Contacts
\n<\/b>
Arcturus Therapeutics
\n
Neda Safarzadeh
\n
VP, Head of IR\/PR\/Marketing
\n
(858) 900-2682
\n
IR@ArcturusRx.com<\/a><\/p>\n

\nKendall Investor Relations
\n
Carlo Tanzi, Ph.D.
\n
(617) 914-0008
\n
ctanzi@kendallir.com<\/a><\/p>\n

KEYWORDS:<\/b> California United States North America<\/p>\n

INDUSTRY KEYWORDS:<\/b> Biotechnology FDA Health Genetics Pharmaceutical<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
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Arcturus Therapeutics Receives U.S. FDA Fast Track Designation forARCT-810, mRNA Therapeutic Candidate for Ornithine Transcarbamylase Deficiency SAN DIEGO–(BUSINESS WIRE)– Arcturus Therapeutics Holdings Inc. (the \u201cCompany\u201d, \u201cArcturus\u201d, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the Company\u2019s mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency. Fast Track Designation is designed to facilitate development and expedite review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address important unmet medical needs. Programs granted Fast Track Designation may receive important benefits including … <\/p>\n

Continue reading “Arcturus Therapeutics Receives U.S. FDA Fast Track Designation forARCT-810, mRNA Therapeutic Candidate for Ornithine Transcarbamylase Deficiency”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-761195","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nArcturus Therapeutics Receives U.S. FDA Fast Track Designation forARCT-810, mRNA Therapeutic Candidate for Ornithine Transcarbamylase Deficiency - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/arcturus-therapeutics-receives-u-s-fda-fast-track-designation-forarct-810-mrna-therapeutic-candidate-for-ornithine-transcarbamylase-deficiency\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Arcturus Therapeutics Receives U.S. FDA Fast Track Designation forARCT-810, mRNA Therapeutic Candidate for Ornithine Transcarbamylase Deficiency - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Arcturus Therapeutics Receives U.S. FDA Fast Track Designation forARCT-810, mRNA Therapeutic Candidate for Ornithine Transcarbamylase Deficiency SAN DIEGO–(BUSINESS WIRE)– Arcturus Therapeutics Holdings Inc. (the \u201cCompany\u201d, \u201cArcturus\u201d, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the Company\u2019s mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency. Fast Track Designation is designed to facilitate development and expedite review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address important unmet medical needs. 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(the \u201cCompany\u201d, \u201cArcturus\u201d, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the Company\u2019s mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency. Fast Track Designation is designed to facilitate development and expedite review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address important unmet medical needs. 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