2022 | HFSA

Cytokinetics Provides Regulatory Update for Omecamtiv Mecarbil

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SOUTH SAN FRANCISCO, Calif., June 17, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that, in response to a request from the U.S. Food and Drug Administration (FDA), the company recently provided additional pharmacokinetic analyses of omecamtiv mecarbil related to the company’s new drug application (NDA). After an initial review of the company’s submission, FDA has communicated that the additional data provided constitutes a major amendment to the NDA and has extended the PDUFA date by three months to February 28, 2023 to provide time for a full review of the submission.

“We are working collaboratively with the FDA as they conduct their review of omecamtiv mecarbil,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are committed to bringing forward our first-in-class cardiac myosin activator, which may provide an important treatment option for patients suffering from worsening heart failure.”