{"id":845617,"date":"2025-05-01T16:34:29","date_gmt":"2025-05-01T20:34:29","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/cytokinetics-announces-new-pdufa-date-for-aficamten-in-obstructive-hypertrophic-cardiomyopathy\/"},"modified":"2025-05-01T16:34:29","modified_gmt":"2025-05-01T20:34:29","slug":"cytokinetics-announces-new-pdufa-date-for-aficamten-in-obstructive-hypertrophic-cardiomyopathy","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cytokinetics-announces-new-pdufa-date-for-aficamten-in-obstructive-hypertrophic-cardiomyopathy\/","title":{"rendered":"Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">SOUTH SAN FRANCISCO, Calif., May  01, 2025  (GLOBE NEWSWIRE) &#8212; Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for <em>aficamten<\/em> for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company\u2019s proposed Risk Evaluation and Mitigation Strategy (REMS).<\/p>\n<p align=\"justify\">Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for <em>aficamten<\/em> in oHCM without an accompanying REMS, and the FDA accepted the NDA for filing. Recently, during the NDA review, the FDA requested that Cytokinetics submit a REMS, based on the inherent characteristics of <em>aficamten<\/em>, which the company provided. The submission of a REMS has now been determined by FDA to be a Major Amendment to the NDA resulting in a standard three-month extension to the original PDUFA action date. No additional clinical data or studies have been requested of Cytokinetics by FDA.<\/p>\n<p align=\"justify\">\u201cWe remain confident in the distinct benefit-risk and pharmaceutic profile of <em>aficamten<\/em> and continue to expect a differentiated label and risk mitigation profile upon its potential approval by FDA,\u201d said Robert I. Blum, Cytokinetics\u2019 President and Chief Executive Officer. \u201cWe look forward to continuing our constructive engagement with the FDA regarding the NDA for <em>aficamten<\/em>.\u201d<\/p>\n<p align=\"justify\">\n        <strong>About Cytokinetics <\/strong>\n      <\/p>\n<p align=\"justify\">Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of <em>aficamten, <\/em>a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). <em>Aficamten<\/em> is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing <em>omecamtiv mecarbil<\/em>, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from <em>aficamten, <\/em>for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function.<\/p>\n<p align=\"justify\">For additional information about Cytokinetics, visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=OVRksLOoBC_oZCS7fqvdtPFoxptWdaa94Mf5PL0iAeOGko6vUxHHEVb-8msMovRs_8c7K5ho9W9_grsxxRIapA==\" rel=\"nofollow\" target=\"_blank\">www.cy<\/a><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=k_EFB_rLhA9vB9B5nyUL5s5Tb_qK5qukAUCV9FAoAEXcqElRsqGF2bxsPalKdiLUtKsHAvTArwPeyytIwMyW8Q==\" rel=\"nofollow\" target=\"_blank\">tokinet<\/a><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=zfLMK1Qk3DWoEvqBBIBUIZV2xYWBEtzyAOikwro-QAk5sCtYSH-NLPcScpfmpkovX8jHXHCAfMTnecb8iljQeA==\" rel=\"nofollow\" target=\"_blank\">ics.com<\/a> and follow us on <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=c_PF-P2chn0r-6H2M0g68cXEP3i1WrgFQgFrNtFXD13b5IhRtVNVm7Ziq7PZQAECKYlRqagkPyFknou5lFHlAw==\" rel=\"nofollow\" target=\"_blank\">X<\/a>, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=URJ8M2VWzq5R5gF5Jb182kkbbCuNbh1eqMBx5kTvmkblZHNQRoXR6sYVcKSIw71MHYB4sEJmaB_mxOopOHNkIOj8kTUCIihsRUkU_yCNPdx_Zfd1MPQd2bNlgQIrxqR8\" rel=\"nofollow\" target=\"_blank\">LinkedIn<\/a>, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=LYhvGMoR5XLGnOwbMIznnepjr1p-KonfWVIDu5U4Q9-bXd8PdbqF0RMRGTlsGWHdBzhpmIy9T8K3w4mh0seRLO8KIUZXE-xHGnsc7z9A3Aw=\" rel=\"nofollow\" target=\"_blank\">Facebook<\/a> and <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=62Y8tI3M4XmHqu6E7kx5gfE1btbQvoz7uug6wo3KmneFY38Of98VVBIjk0XsmgGd8ySpRviTtB-kpWxVsgZknzfV8tFKZpwEoMmoH1nsF81NaUIJSIOKrJTW7SxDI3Og\" rel=\"nofollow\" target=\"_blank\">YouTube<\/a>.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statements <\/strong>\n      <\/p>\n<p align=\"justify\">This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the \u201cAct\u201d). Cytokinetics claims the protection of the Act\u2019s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of <em>aficamten<\/em> in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, and statements regarding our expectation that <em>aficamten<\/em> will be approved with a differentiated label and REMS. Such statements are based on management&#8217;s current expectations, but actual results may differ materially due to various risks and uncertainties, including FDA\u2019s on-going review of our NDA for <em>aficamten<\/em> in obstructive hypertrophic cardiomyopathy. For further information regarding these and other risks related to Cytokinetics\u2019 business, investors should consult Cytokinetics\u2019 filings with the Securities and Exchange Commission, particularly under the caption \u201cRisk Factors\u201d in Cytokinetics\u2019 Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statements that\u00a0Cytokinetics\u00a0makes in this press release speak only as of the date of this press release.\u00a0Cytokinetics\u00a0assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.<\/p>\n<p align=\"justify\">CYTOKINETICS\u00ae and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.<\/p>\n<p align=\"justify\">\n        <strong>Contact:<\/strong><br \/>\n        <br \/>Cytokinetics <br \/>Diane Weiser<br \/>Senior Vice President, Corporate Affairs<br \/>(415) 290-7757<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTQ0MzA2NiM2OTE3MDMzIzIwMDUxMDM=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/NTIzMGY3MTgtN2JkZS00YjNkLWEyN2MtY2VhZWQ3NDkxNDMxLTEwMTY2NzYtMjAyNS0wNS0wMS1lbg==\/tiny\/Cytokinetics-Incorporated.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) &#8212; Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company\u2019s proposed Risk Evaluation and Mitigation Strategy (REMS). Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS, and the FDA accepted the NDA for filing. Recently, during the NDA review, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/cytokinetics-announces-new-pdufa-date-for-aficamten-in-obstructive-hypertrophic-cardiomyopathy\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy&#8221;<\/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-845617","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy - 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\/cytokinetics-announces-new-pdufa-date-for-aficamten-in-obstructive-hypertrophic-cardiomyopathy\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) &#8212; Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company\u2019s proposed Risk Evaluation and Mitigation Strategy (REMS). Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS, and the FDA accepted the NDA for filing. 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The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company\u2019s proposed Risk Evaluation and Mitigation Strategy (REMS). Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS, and the FDA accepted the NDA for filing. 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