Cytokinetics (CYTK) announced the FDA has accepted the companys New Drug Application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy. The FDA assigned the NDA a standard review with a PDUFA target action date of September 26, 2025. The company noted that the FDA is not currently planning to hold an advisory committee meeting to discuss the application.
The FDA previously granted aficamten Orphan Drug Designation for the treatment of symptomatic HCM in January 2021 and Breakthrough Therapy Designation for the treatment of obstructive HCM in December 2021.
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Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.