Cytokinetics Wins FDA Nod For Heart Drug Myqorzo

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On Friday, the U.S. Food and Drug Administration (FDA) approved Cytokinetics Incorporated’s (NASDAQ:CYTK) Myqorzo (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve ...

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It reduces heart's pumping ability, has a warning for heart failure and expected to launch in 2026.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4505":"高瓴资本持仓","BK4139":"生物科技","BK4585":"ETF&股票定投概念","CYTK":"Cytokinetics","BK4588":"碎股"},"translate_title":"Cytokinetics心脏病药物Myqorzo获得FDA批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CYTK":1.5},"content_text":"On Friday, the U.S. Food and Drug Administration (FDA) approved Cytokinetics Incorporated’s (NASDAQ:CYTK) Myqorzo (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.\nMyqorzo is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with Myqorzo reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.\nThe full U.S. Prescribing Information for Myqorzo includes a Boxed WARNING for the risk of heart failure.\nAlso Read: Bristol Myers Faces Another Trial Disappointment As Heart Drug Milvexian Fails To Show Efficacy\nMyqorzo reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.\nSystolic dysfunction means the heart’s main pumping chamber (left ventricle) is weak and can’t contract properly, failing to pump enough oxygen-rich blood to the body.\nEchocardiogram assessments are required before and during treatment with Myqorzo to monitor for systolic dysfunction.\nMyqorzo is expected to be available in the U.S. in the second half of January 2026.\nThe approval is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints.\nThe results from SEQUOIA-HCM showed that treatment with Myqorzo for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.8 mL/kg/min compared to baseline in patients treated with Myqorzo versus 0.0 mL/kg/min in patients treated with placebo.\nWall Street struck a broadly bullish tone on Cytokinetics, with multiple firms reiterating positive ratings and raising their price forecasts. HC Wainwright maintained a Buy and raised its price forecast to $136 from $120. \nNeedham reaffirmed a Buy and lifted its price forecast to $84 from $72. Citizens maintained a Market Outperform and increased its price forecast to $88 from $78. \nBarclays reiterated an Overweight rating and raised its price forecast to $87 from $82, while RBC Capital maintained an Outperform and lifted its price forecast to $95 from $87.\nCYTK Price Action: Cytokinetics shares were up 11.70% at $70.02 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.\nRead Next:\nPhoto by Tada Images via Shutterstock","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.35.12","shortVersion":"4.35.12","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2593431812","isCrawlerRequest":true}