Biopharmaceutical company Cytokinetics’ (NASDAQ:CYTK) heart drug omecamtiv mecarbil failed to gain support from a committee of the U.S. Food and Drug Administration (FDA) due to safety and efficacy concerns. Cytokinetics is seeking approval for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction. CYTK stock fell 6% in Tuesday’s extended trading session.
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The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8-3 against Cytokinetics’ heart drug as the benefits from the treatment do not outweigh its risks. Last week, FDA staff reviewers noted several safety and efficacy concerns about omecamtiv mecarbil. This led the FDA to ask the Cardiovascular and Renal Drugs Advisory Committee to assess some key questions about the drug.
Omecamtiv mecarbil aims to enhance the activity of myosin, a protein that plays a vital role in improving the heart’s pumping. As per Reuters, the FDA committee advised that Cytokinetics should gather additional data on the drug’s ability to reduce the risk of heart failure-related death. Committee member Csaba Kovesdy stated, “The level of evidence afforded by a single clinical trial does not give sufficient comfort to state that the drug’s benefit outweighs its risks.”
Cytokinetics’ president and CEO Robert I. Blum stated that the company was disappointed with the FDA committee’s decision and continues to believe that its heart drug can be a “valuable add-on therapy for patients with worsening heart failure who remain at high risk for heart failure.” The company intends to “engage constructively” with the FDA in the regulatory body’s review of the application for omecamtiv mecarbil.
Is CYTK a Buy?
Cytokinetics scores the Street’s Strong Buy consensus rating based on eight unanimous Buys. The average CYTK stock price target of $71 implies upside potential of 85.2%. Shares are down 16% year-to-date.
