Monday, May 27, 2024

Cytokinetics maintains $99 target on positive trial data

On Friday, Cytokinetics , Inc. (NASDAQ:CYTK) retained its favorable outlook from Mizuho, with a reiterated Buy rating and a steady price target of $99.00. The biopharmaceutical company, which focuses on muscle biology and related therapies, showcased new data from its ongoing heart disease study during a prominent medical conference.

The data presented stems from a 48-week study involving 46 patients with obstructive hypertrophic cardiomyopathy (oHCM) participating in the FOREST-HCM trial, an open-label extension study of the drug aficamten. Key findings highlighted a significant reduction in left ventricular outflow tract gradient (LVOT-G) at rest and during the Valsalva maneuver, a common diagnostic test for heart conditions. Additionally, more than 80% of patients experienced at least one class improvement in New York Heart Association (NYHA) functional classification, which is a measure of the severity of heart failure.

Further positive outcomes included an average 63% decrease from baseline in NT-proBNP, a biomarker for heart stress, and improvements in cardiac structure and function. This includes a decrease in maximum wall thickness and left atrial volume index, as well as a reduction in the ratio of early mitral inflow velocity to mitral annular early diastolic velocity (E/e’), which are all indicators of better heart performance. Moreover, the study reported a 94% reduction in septal reduction therapy (SRT) eligibility, a treatment for oHCM, and a mean reduction in left ventricular ejection fraction (LVEF) of 5.1%.

The company believes these results contribute to a growing body of evidence supporting the long-term benefits of aficamten and could influence future regulatory discussions. Mizuho highlighted that no discontinuations were observed during the study, which may position aficamten favorably in terms of safety when compared to mavacamten (Camzyos), another oHCM treatment by Bristol Myers (NYSE:BMY) Squibb, which is not covered by the firm. Cytokinetics has previously indicated its aim to establish a “differentiated REMS” (Risk Evaluation and Mitigation Strategy) program for aficamten, potentially distinguishing it in the market.

The latest findings build upon previous reports from the company, including 12-week data from 143 patients released on October 19, 2023, and 48-week data from 16 patients at the Cardiomyopathy Registry (CMR) on January 25, 2024, which also suggested a positive trend for aficamten’s longer-term efficacy and safety profile.

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