{"id":47937,"date":"2022-09-02T19:02:23","date_gmt":"2022-09-02T17:02:23","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/amylyx-pharmaceuticals-announces-posting-of-briefing-documents-for-second-fda-advisory-committee-meeting-on-amx0035\/"},"modified":"2022-09-02T19:02:23","modified_gmt":"2022-09-02T17:02:23","slug":"amylyx-pharmaceuticals-announces-posting-of-briefing-documents-for-second-fda-advisory-committee-meeting-on-amx0035","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/amylyx-pharmaceuticals-announces-posting-of-briefing-documents-for-second-fda-advisory-committee-meeting-on-amx0035\/","title":{"rendered":"Amylyx Pharmaceuticals Announces Posting of Briefing Documents for Second FDA Advisory Committee Meeting on AMX0035"},"content":{"rendered":"<div>\n<p>CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211;Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (\u201cAmylyx or the \u201cCompany\u201d) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the reconvened Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS).\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220831005780\/en\/802420\/5\/13268_Amylyx_logo_notagline-Color.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220831005780\/en\/802420\/21\/13268_Amylyx_logo_notagline-Color.jpg\"><\/a><\/p>\n<p>\nThe second meeting of the PCNSDAC for the AMX0035 NDA is scheduled for 12:00 p.m. ET on Wednesday, September 7, 2022. The briefing materials and webcast information can be accessed <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fadvisory-committees%2Fadvisory-committee-calendar%2Fseptember-7-2022-meeting-peripheral-and-central-nervous-system-drugs-advisory-committee-meeting&amp;esheet=52848842&amp;newsitemid=20220831005780&amp;lan=en-US&amp;anchor=here&amp;index=1&amp;md5=23cd59b52fce665c54204423b16aa76b\" rel=\"nofollow noopener\" shape=\"rect\">here<\/a>. The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA.\n<\/p>\n<p>\nThe PCNSDAC previously met on March 30, 2022 to discuss the NDA for AMX0035 for the treatment of ALS. The Prescription Drug User Fee Act (PDUFA) target action date for the NDA is September 29, 2022, which was extended by the FDA to allow more time to review additional analyses of data from the Company\u2019s clinical studies.\n<\/p>\n<p>\n<b>About AMX0035<br \/>\n<br \/><\/b>AMX0035 (sodium phenylbutyrate and taurursodiol) is an oral fixed-dose medication with marketing applications pending in the United States and European Union and approved with conditions as ALBRIOZA\u2122 to treat amyotrophic lateral sclerosis (ALS) in Canada. The combination of sodium phenylbutyrate and taurursodiol may reduce neuronal cell death, hypothesized to occur by simultaneously mitigating endoplasmic reticulum stress and mitochondrial dysfunction. AMX0035 is also being explored for the potential treatment of other neurodegenerative diseases.\n<\/p>\n<p>\n<b>About Amylyx Pharmaceuticals<br \/>\n<br \/><\/b>Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative community through the discovery and development of innovative new treatments. Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada and EMEA. For more information, visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Famylyx.com&amp;esheet=52848842&amp;newsitemid=20220831005780&amp;lan=en-US&amp;anchor=amylyx.com&amp;index=2&amp;md5=d56fc22f07920c00f951e934e54a5852\" rel=\"nofollow noopener\" shape=\"rect\">amylyx.com<\/a> and follow us on <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Famylyx&amp;esheet=52848842&amp;newsitemid=20220831005780&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=3&amp;md5=564c312e84bf9807e6e8d024b4f4c6f0\" rel=\"nofollow noopener\" shape=\"rect\">LinkedIn<\/a> and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FAmylyxPharma&amp;esheet=52848842&amp;newsitemid=20220831005780&amp;lan=en-US&amp;anchor=Twitter&amp;index=4&amp;md5=0611f475eb01907eb9a331e7820d307e\" rel=\"nofollow noopener\" shape=\"rect\">Twitter<\/a>. For investors, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Finvestors.amylyx.com%2F&amp;esheet=52848842&amp;newsitemid=20220831005780&amp;lan=en-US&amp;anchor=investors.amylyx.com&amp;index=5&amp;md5=aa4c6305ad881b70d26da4e04396ebd2\" rel=\"nofollow noopener\" shape=\"rect\">investors.amylyx.com<\/a>.\n<\/p>\n<p>\n<b>Forward-Looking Statements<br \/>\n<br \/><\/b>Statements contained in this press release regarding matters that are not historical facts are \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding beliefs about the clinical study analyses of AMX0035, the potential regulatory approval of AMX0035 and the potential of AMX0035 or other future therapeutic candidates as a treatment for ALS and other neurodegenerative diseases. Any forward-looking statements in this statement are based on management\u2019s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx\u2019 program development activities, Amylyx\u2019 ability to execute on its strategy, regulatory developments, expectations regarding the timing of regulatory review of AMX0035 and the inherent unpredictability of the regulatory review process, Amylyx\u2019 ability to fund operations, and the impact that the ongoing COVID-19 pandemic will have on Amylyx\u2019 operations, as well as those risks and uncertainties set forth in Amylyx\u2019 United States Securities and Exchange Commission (SEC) filings, including Amylyx\u2019 Annual Report on Form 10-K for the year ended December 31, 2021, and subsequent filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media<\/b><br \/>Becky Gohsler<br \/>\n<br \/>Finn Partners<br \/>\n<br \/>(646) 307-6307<br \/>\n<br \/><a target=\"_blank\" href=\"mailto:amyly&#120;&#109;&#101;&#100;&#105;&#97;&#116;&#101;&#97;&#109;&#64;&#97;&#109;&#121;&#108;&#x79;&#x78;&#x2e;&#x63;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#97;&#x6d;y&#x6c;&#x79;&#120;&#x6d;e&#100;&#x69;&#97;&#x74;e&#97;&#x6d;&#64;&#x61;m&#121;&#x6c;y&#x78;&#x2e;&#99;&#x6f;m<\/a><\/p>\n<p><b>Investors<\/b><br \/>Lindsey Allen<br \/>\n<br \/>Amylyx Pharmaceuticals, Inc.<br \/>\n<br \/>(857) 320-6244<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;i&#x6c;&#x74;&#111;&#x3a;I&#110;&#x76;&#101;&#x73;t&#111;&#x72;s&#x40;a&#109;&#x79;l&#x79;&#x78;&#46;&#x63;o&#109;\" rel=\"nofollow noopener\" shape=\"rect\">Investor&#115;&#64;&#97;&#109;&#121;&#108;&#121;&#120;&#46;&#99;&#x6f;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211;Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (\u201cAmylyx or the \u201cCompany\u201d) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the reconvened Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/amylyx-pharmaceuticals-announces-posting-of-briefing-documents-for-second-fda-advisory-committee-meeting-on-amx0035\/\">[Read more&#8230;]<\/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-47937","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Amylyx Pharmaceuticals Announces Posting of Briefing Documents for Second FDA Advisory Committee Meeting on AMX0035 - 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\/amylyx-pharmaceuticals-announces-posting-of-briefing-documents-for-second-fda-advisory-committee-meeting-on-amx0035\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Amylyx Pharmaceuticals Announces Posting of Briefing Documents for Second FDA Advisory Committee Meeting on AMX0035 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211;Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (\u201cAmylyx or the \u201cCompany\u201d) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the reconvened Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for ... 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(Nasdaq: AMLX) (\u201cAmylyx or the \u201cCompany\u201d) today announced that the U.S. Food and Drug Administration (FDA) posted briefing documents for the reconvened Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) meeting to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for ... 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