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H2R

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H2R

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Saturday, 06/25/2022 11:55:55 PM

Saturday, June 25, 2022 11:55:55 PM

Post# of 1569
AdCom scheduled for December 13, 2022.


Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that the previously announced meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the New Drug Application for omecamtiv mecarbil is currently scheduled for December 13, 2022. The FDA has assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2023. Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF).



https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-date-fda-advisory-committee-meeting

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