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H2R

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Tuesday, 12/13/2022 1:40:37 PM

Tuesday, December 13, 2022 1:40:37 PM

Post# of 1569
Trading halted today

FDA Advisory Committee to Review the New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure with Reduced Ejection Fraction

SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Nasdaq has halted the trading of the Company’s common stock. The U.S. Food & Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) is meeting today to review the New Drug Application (NDA) for omecamtiv mecarbil, an investigational selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF).

The advisory committee meeting, which is being held virtually, is scheduled to begin at 9:00 AM ET today. Briefing materials and webcast information for the meeting can be accessed at https://www.fda.gov/advisory-committees/advisory-committee-calendar/december-13-2022-cardiovascular-and-renal-drugs-advisory-committee-meeting-announcement-12132022. The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA.

The NDA for omecamtiv mecarbil is based on the results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 clinical trial of omecamtiv mecarbil. The Prescription Drug User Fee Act (PDUFA) target action date for the NDA is February 28, 2023.



https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-stock-trading-halted-today
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