2022 | HFSA

Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbil

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SOUTH SAN FRANCISCO, Calif., May 17, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the Company recently participated in a mid-cycle communication meeting with the U.S. Food & Drug Administration (FDA) and was informed that the Agency plans to convene an Advisory Committee meeting for the New Drug Application (NDA) for omecamtiv mecarbil. Cytokinetics expects the FDA to inform it of the date and topics for the Advisory Committee Meeting in a subsequent communication. A late-cycle communication meeting has been proposed to occur later this year. Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF). The FDA has assigned the NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022.