Cytokinetics Inc

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Cytokinetics Provides Regulatory Update For Omecamtiv Mecarbil

Published: 06/17/2022 11:40 GMT
Cytokinetics Inc (CYTK) - Cytokinetics Provides Regulatory Update for Omecamtiv Mecarbil.
Cytokinetics Inc - Recently Provided Additional Pharmacokinetic Analyses of Omecamtiv Mecarbil Related to Company's New Drug Application to FDA.
Cytokinetics Inc - After an Initial Review of Submission, FDA Has Communicated That Additional Data Provided Constitutes a Major Amendment to NDA.
Cytokinetics Inc - FDA Has Extended PDUFA Date by Three Months to February 28, 2023 to Provide Time for a Full Review of Submission.