{"id":44656,"date":"2022-06-03T13:01:23","date_gmt":"2022-06-03T11:01:23","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/amylyx-pharmaceuticals-receives-notification-of-pdufa-date-extension-for-amx0035-for-the-treatment-of-als\/"},"modified":"2022-06-03T13:01:23","modified_gmt":"2022-06-03T11:01:23","slug":"amylyx-pharmaceuticals-receives-notification-of-pdufa-date-extension-for-amx0035-for-the-treatment-of-als","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/amylyx-pharmaceuticals-receives-notification-of-pdufa-date-extension-for-amx0035-for-the-treatment-of-als\/","title":{"rendered":"Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\nNew PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data\n<\/li>\n<\/ul>\n<p>CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211;Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (\u201cAmylyx\u201d or the \u201cCompany\u201d) today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol [TURSO; also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). The updated Prescription Drug User Fee Act (PDUFA) goal date is September 29, 2022.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220602006037\/en\/802420\/5\/13268_Amylyx_logo_notagline-Color.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220602006037\/en\/802420\/21\/13268_Amylyx_logo_notagline-Color.jpg\"><\/a><\/p>\n<p>\nThe FDA extended the PDUFA date to allow more time to review additional analyses of data from the Company\u2019s clinical studies. The submission of this information has been determined by the FDA to constitute a major amendment to the NDA, resulting in an extension of the PDUFA goal date.\n<\/p>\n<p>\n\u201cWe are confident in the potential of AMX0035 to help people living with ALS and other neurodegenerative diseases, and we continue to work closely with the FDA as they complete their review,\u201d said Justin Klee and Joshua Cohen, Co-CEOs and Co-Founders of Amylyx.\n<\/p>\n<p>\n<b>About AMX0035<br \/>\n<br \/><\/b>AMX0035 is a proprietary oral fixed-dose combination of two small molecules: sodium phenylbutyrate (PB), which is a small molecular chaperone designed to reduce the unfolded protein response (UPR), preventing cell death resulting from the UPR, and taurursodiol (TURSO; also known as ursodoxicoltaurine), which is a Bax inhibitor designed to reduce cell death through apoptosis. PB and TURSO were combined in a fixed-dose formulation in an effort to reduce neuronal death and dysfunction. AMX0035 is designed to target the endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways in ALS and other neurodegenerative diseases.\n<\/p>\n<p>\n<b>About the CENTAUR Trial<br \/>\n<br \/><\/b>CENTAUR was a multicenter Phase 2 clinical trial in 137 participants with ALS encompassing a 6-month randomized placebo-controlled phase and an open-label long-term follow-up phase. The trial met its primary efficacy endpoint of reducing functional decline as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R).\n<\/p>\n<p>\nOverall, reported rates of adverse events and discontinuations were similar between AMX0035 and placebo groups during the 24-week randomized phase; however, gastrointestinal events occurred with greater frequency (\u22652%) in the AMX0035 group. Detailed safety and functional efficacy data from CENTAUR were published in the <i>New England Journal of Medicine<\/i>. Data from additional analyses from the CENTAUR trial were published in <i>Muscle &amp; Nerve<\/i> in 2020 and 2022, and the <i>Journal of Neurology, Neurosurgery and Psychiatry<\/i> in 2022.\n<\/p>\n<p>\nThe CENTAUR trial was funded, in part, by the ALS ACT grant and the ALS Ice Bucket Challenge, and was supported by The ALS Association, ALS Finding a Cure (a program of The Leandro P. Rizzuto Foundation), the Northeast ALS Consortium, and the Sean M. Healey &amp; AMG Center for ALS at Mass General.\n<\/p>\n<p>\n<b>About Amylyx Pharmaceuticals<br \/>\n<br \/><\/b>Amylyx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company working on developing a novel therapeutic for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. For more information, visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.amylyx.com%2F&amp;esheet=52738642&amp;newsitemid=20220602006037&amp;lan=en-US&amp;anchor=amylyx.com&amp;index=1&amp;md5=399053723b19b70b13341ad226a0ed1f\" 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%2F35623123&amp;esheet=52738642&amp;newsitemid=20220602006037&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=2&amp;md5=17636f57a62c1f209ffd8026ca7562e2\" 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=52738642&amp;newsitemid=20220602006037&amp;lan=en-US&amp;anchor=Twitter&amp;index=3&amp;md5=525537965e517b86a74df8d86057f119\" 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=52738642&amp;newsitemid=20220602006037&amp;lan=en-US&amp;anchor=investors.amylyx.com&amp;index=4&amp;md5=97279e85fd4744dadb6c16f2bc371216\" 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 &#8220;forward-looking statements&#8221; 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: Amylyx\u2019 strategy, business plans and objectives for 2022 and beyond; the potential of AMX0035 as a treatment for ALS, the efficacy and safety profile of AMX0035 and the potential for regulatory approval of AMX0035 as a treatment for ALS in the U.S.; the potential commercial launch of AMX0035 as a treatment for ALS, if approved; the potential of AMX0035 or other future therapeutic candidates as a treatment for neurodegenerative diseases generally; and expectations regarding our longer-term strategy. 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 commercial and regulatory strategy, regulatory developments, expectations regarding the timing of FDA review of AMX0035 for the treatment of ALS, 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=\"&#109;&#x61;i&#108;&#x74;o&#58;&#x61;m&#x79;&#x6c;&#121;&#x78;m&#101;&#x64;i&#97;&#x74;e&#x61;&#x6d;&#64;&#x61;&#x6d;&#121;&#x6c;y&#120;&#x2e;c&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">a&#109;&#121;&#x6c;&#x79;&#x78;&#x6d;e&#100;&#105;&#97;&#x74;&#x65;&#x61;m&#64;&#97;&#109;&#x79;&#x6c;&#x79;x&#46;&#99;&#111;&#x6d;<\/a>\n<\/p>\n<p>\n<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=\"m&#97;&#105;&#x6c;&#x74;&#x6f;:&#73;&#110;&#x76;&#x65;&#x73;to&#114;&#x73;&#x40;&#x61;my&#108;&#121;&#x78;&#x2e;&#x63;o&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x49;&#x6e;&#118;e&#x73;&#x74;&#111;rs&#x40;&#x61;&#109;y&#x6c;&#x79;&#120;&#46;c&#x6f;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211;Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (\u201cAmylyx\u201d or the \u201cCompany\u201d) today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/amylyx-pharmaceuticals-receives-notification-of-pdufa-date-extension-for-amx0035-for-the-treatment-of-als\/\">[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-44656","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS - 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-receives-notification-of-pdufa-date-extension-for-amx0035-for-the-treatment-of-als\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data CAMBRIDGE, Mass.&#8211;(BUSINESS WIRE)&#8211;Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (\u201cAmylyx\u201d or the \u201cCompany\u201d) today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol ... 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(NASDAQ: AMLX) (\u201cAmylyx\u201d or the \u201cCompany\u201d) today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol ... 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