SOUTH SAN FRANCISCO – The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for aficamten, a cardiac myosin inhibitor developed by Cytokinetics (NASDAQ:CYTK) (market capitalization: $6.12 billion), for the treatment of obstructive hypertrophic cardiomyopathy (HCM). According to InvestingPro data, the company's stock has shown strong momentum with a 54.48% return over the past year, despite being down 37.88% year-to-date. The NDA has been assigned a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2025.
Aficamten, if approved, could offer a new treatment option for patients with HCM, a condition where the heart muscle becomes abnormally thick. The drug aims to reduce myocardial hypercontractility associated with HCM by decreasing the number of active actin-myosin cross bridges during each cardiac cycle.
The submission is backed by data from the SEQUOIA-HCM Phase 3 clinical trial, which demonstrated significant improvements in exercise capacity and various clinical outcomes for patients with obstructive HCM. Analysts maintain a bullish outlook on Cytokinetics, with price targets ranging from $60 to $120 per share. For deeper insights into analyst forecasts and comprehensive financial analysis, consider accessing the detailed Pro Research Report available on InvestingPro. The trial's results, published in the New England Journal of Medicine, showed a notable increase in peak oxygen uptake after 24 weeks of treatment with aficamten, compared to placebo. Additionally, the trial reported statistically significant improvements in secondary endpoints and a favorable safety and tolerability profile.
Cytokinetics' President and CEO, Robert I. Blum, expressed optimism about the potential benefits of aficamten for patients with HCM. The company anticipates that aficamten may become a preferred treatment option and a foundation for its cardiology franchise.
Aficamten has previously received Orphan Drug Designation for the treatment of symptomatic HCM in January 2021 and Breakthrough Therapy Designation for obstructive HCM in December 2021. The drug is also under review in China and is being evaluated in other ongoing clinical trials for various HCM conditions.
HCM affects a significant population, with an estimated 280,000 diagnosed patients in the U.S. and potentially hundreds of thousands undiagnosed. It can lead to severe health complications, including atrial fibrillation, stroke, and sudden cardiac death.
Cytokinetics is a biopharmaceutical company specializing in the development of muscle biology-directed drug candidates for cardiovascular diseases. Besides aficamten, the company is advancing other potential treatments targeting cardiac and skeletal muscle function. While the company maintains a strong liquidity position with a current ratio of 9.28 and operates with moderate debt levels, InvestingPro analysis reveals 11 additional key insights about the company's financial health and growth prospects, available to subscribers.
This news article is based on a press release statement from Cytokinetics, Incorporated.
In other recent news, Cytokinetics has entered into a significant agreement with Bayer (OTC:BAYRY) Consumer Care AG for the development and commercialization of its cardiac sarcomere inhibitor, aficamten, in Japan. The deal includes an upfront payment of €50 million, with potential additional payments of up to €90 million based on certain clinical and commercial milestones. Furthermore, Cytokinetics has completed New Drug Application submissions for aficamten in the U.S. and China, with a submission to the European Medicines Agency expected in the fourth quarter of 2024.
Analyst firms Goldman Sachs and H.C. Wainwright have maintained their Neutral and Buy ratings respectively on Cytokinetics, citing recent developments and promising data on aficamten and omecamtiv mecarbil. Goldman Sachs has highlighted the commercial execution of aficamten for obstructive hypertrophic cardiomyopathy as a critical area of focus for investors in the near future.
Additionally, Santo J. Costa has resigned from the Cytokinetics Board of Directors, reducing the board from nine to eight members. This change is unrelated to any disputes regarding the company's operations, policies, or practices. These are all recent developments as Cytokinetics continues to advance its pipeline of drug candidates.
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