10 Firms Battered by Poor Earnings, Dismal Outlook

3. Cytokinetics, Inc. (NASDAQ:CYTK)

Cytokinetics fell by 12.98 percent on Friday to finish at $37.35 apiece as investor sentiment was weighed down by the Food and Drug Administration’s (FDA) decision to delay its approval of the company’s heart treatment.

According to the FDA, it asked Cytokinetics, Inc. (NASDAQ:CYTK) for the risk evaluation and mitigation strategy of aficamten, which pushed back the result of its review to December 26 from the original target date of September. The company said it had already complied with the request.

Aficamten is currently under review as a treatment for obstructive hypertrophic cardiomyopathy, a heart disorder in which cardiac muscle becomes abnormally thick, making it harder for the heart to pump blood.

“We believe the commercial prospects of aficamten are highly dependent on whether FDA approves aficamten with a label and/or post-marketing conditions that are less challenging to prescribers and patients than the REMS applicable to Camzyos, Cytokinetics, Inc. (NASDAQ:CYTK) said in its report.

For his part, Cytokinetics President and CEO Robert Blum said that he “remains confident in the distinct benefit-risk and pharmaceutic profile of aficamten and continues to expect a differentiated label and risk mitigation profile upon its potential approval by the FDA.”