SOUTH SAN FRANCISCO - Cytokinetics (NASDAQ:CYTK), Incorporated (NASDAQ:CYTK) shared new data from its FOREST-HCM study, evaluating the long-term effects of aficamten, an investigational cardiac myosin inhibitor, on patients with hypertrophic cardiomyopathy (HCM). The findings were presented at the 73rd Annual American College of Cardiology Scientific Session in Atlanta, GA.
The open-label extension clinical study enrolled 213 patients and focused on 46 who completed 48 weeks of follow-up. The results showed that 75% of these patients experienced significant and sustained reductions in left ventricle outflow tract gradient (LVOT-G) and improvements in symptoms and cardiac biomarkers after being treated with 15 mg or 20 mg doses of aficamten.
Statistically significant improvements were noted in the New York Heart Association (NYHA) Functional Class, with 82.2% of patients improving by at least one NYHA class. Moreover, significant reductions in NT-proBNP levels, a biomarker for cardiac wall stress, were observed, alongside improvements in cardiac structure and function, including decreases in maximum wall thickness and left atrial volume index.
The study also indicated a 94% reduction in the number of patients eligible for septal reduction therapy (SRT), a treatment for obstructive HCM, after six months of aficamten treatment. Aficamten was well-tolerated with no treatment-related serious adverse events (SAEs) reported, although there was a modest reduction in left ventricular ejection fraction (LVEF) over the 48 weeks.
Fady I. Malik, M.D., Ph.D., Executive Vice President of Research & Development at Cytokinetics, commented on the efficacy and safety of longer-term treatment with aficamten, highlighting the significant improvements in patient symptoms and cardiac function.
Aficamten, which has received Breakthrough Therapy Designation from the FDA, is designed to suppress myocardial hypercontractility associated with HCM by reducing active actin-myosin cross bridges during cardiac cycles. It is currently being evaluated in two ongoing Phase 3 clinical trials, MAPLE-HCM and ACACIA-HCM, following positive results from the pivotal Phase 3 SEQUOIA-HCM trial.
The company, specializing in cardiovascular treatments, is preparing for regulatory submissions for aficamten following these positive trial outcomes. This report is based on a press release statement from Cytokinetics.
InvestingPro Insights
As Cytokinetics (NASDAQ:CYTK) continues to make strides with its aficamten program for hypertrophic cardiomyopathy (HCM), investors are closely monitoring the company's financial health and market performance. According to InvestingPro, Cytokinetics has a market cap of approximately $7.13 billion. However, the company's financial metrics show challenges, with a negative P/E ratio of -12.69 for the last twelve months as of Q4 2023, indicating that the company is not currently profitable.
The revenue for Cytokinetics has seen a substantial decline, with a decrease of 92.04% over the last twelve months as of Q4 2023. This aligns with the InvestingPro Tips that analysts anticipate a sales decline in the current year and do not expect the company to be profitable this year. Despite these financial hurdles, Cytokinetics has shown a high return over the last year, with a 91.32% price total return, reflecting investor optimism possibly tied to the clinical advancements of aficamten.
InvestingPro also highlights that Cytokinetics operates with a moderate level of debt and has liquid assets that exceed its short-term obligations, which could provide some financial flexibility as it moves towards regulatory submissions. It's worth noting that the company does not pay a dividend to shareholders, which is typical for biotech companies focused on reinvesting earnings into research and development.
For investors seeking more in-depth analysis and additional insights, InvestingPro offers a range of tips, including the company's gross profit margins and valuation multiples. There are 12 additional InvestingPro Tips available for Cytokinetics, which can be accessed at https://www.investing.com/pro/CYTK. Interested readers can use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, potentially aiding in making more informed investment decisions.
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