FDA extends review period for Cytokinetics’ heart drug

Published 01/05/2025, 21:24
FDA extends review period for Cytokinetics’ heart drug

This news is based on a press release statement from Cytokinetics, and the company’s forward-looking statements are subject to various risks and uncertainties, including the ongoing FDA review process. Analysts remain optimistic about the company’s prospects, with price targets ranging from $47 to $120 per share. For deeper insights into Cytokinetics’ financial health and growth potential, including additional ProTips and comprehensive analysis, visit InvestingPro, where you’ll find expert research reports and detailed financial metrics. Analysts remain optimistic about the company’s prospects, with price targets ranging from $47 to $120 per share. For deeper insights into Cytokinetics’ financial health and growth potential, including additional ProTips and comprehensive analysis, visit InvestingPro, where you’ll find expert research reports and detailed financial metrics.

This news is based on a press release statement from Cytokinetics, and the company’s forward-looking statements are subject to various risks and uncertainties, including the ongoing FDA review process. Analysts remain optimistic about the company’s prospects, with price targets ranging from $47 to $120 per share. For deeper insights into Cytokinetics’ financial health and growth potential, including additional ProTips and comprehensive analysis, visit InvestingPro, where you’ll find expert research reports and detailed financial metrics.

Cytokinetics’ President and CEO, Robert I. Blum, expressed confidence in aficamten’s benefit-risk profile and the company’s ongoing dialogue with the FDA. The company anticipates a differentiated label and risk mitigation profile upon potential approval.

Aficamten, a cardiac myosin inhibitor, has shown promise in the SEQUOIA-HCM pivotal Phase 3 clinical trial for patients with oHCM. It is also undergoing additional clinical trials for both obstructive and non-obstructive HCM. Apart from aficamten, Cytokinetics is developing several other cardiovascular drugs, including omecamtiv mecarbil for heart failure with severely reduced ejection fraction (HFrEF), and CK-586 and CK-089 for other cardiac and skeletal muscle dysfunctions.

The announcement emphasizes that the FDA has not requested additional clinical data or studies for aficamten, and the company remains ready for potential regulatory approvals and commercialization. This extension is based on the FDA’s need for a full review of the proposed REMS, which is a standard procedure to ensure the safety and efficacy of new medications.

This news is based on a press release statement from Cytokinetics, and the company’s forward-looking statements are subject to various risks and uncertainties, including the ongoing FDA review process.

In other recent news, Cytokinetics has been the focus of several analyst reports and developments. Barclays initiated coverage with an Overweight rating and a price target of $55, emphasizing the potential of Cytokinetics’ leading drug candidate, aficamten, for treating obstructive hypertrophic cardiomyopathy (oHCM). H.C. Wainwright maintained its Buy rating and a higher price target of $120, expressing optimism about aficamten’s prospects following label updates to a competitor’s drug, Camzyos. Stifel also reiterated a Buy rating with a target of $87, citing regulatory changes that could favorably impact the cardiomyopathy market and aficamten’s potential differentiation.

The recent failure of Bristol-Myers Squibb’s Phase 3 ODYSSEY-HCM trial for non-obstructive hypertrophic cardiomyopathy (nHCM) led to concerns about the class of cardiac myosin inhibitors, affecting Cytokinetics’ shares. Despite this, analysts like Citi’s David Lebowitz pointed out differences between the ODYSSEY and Cytokinetics’ ACACIA trials that could lead to success for aficamten. The market continues to watch closely as Cytokinetics positions aficamten in a potentially lucrative market, with analysts projecting a significant market opportunity.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.