Cytokinetics, Incorporated announced that Nasdaq has halted the trading of the Company’s common stock. The U.S. Food & Drug Administration Cardiovascular and Renal Drugs Advisory Committee is meeting to review the New Drug Application for omecamtiv mecarbil, an investigational selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction. The advisory committee meeting, which is being held virtually, is scheduled to begin at 9:00 AM.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, the Phase 3 clinical trial of omecamtiv mecarbil. The Prescription Drug User Fee Act target action date for the NDA is February 28, 2023.
Published first on TheFly
See Insiders’ Hot Stocks on TipRanks >>
Read More on CYTK:
- Cytokinetics (NASDAQ:CYTK) Stock Falls; Investors Disheartened by Heart Drug Problems
- Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil
- Cytokinetics Stock Trading Halted Today
- FDA Cardiovascular & Renal Drugs Advisory Committee to hold virtual meeting
- Piper says negative Cytokinetics FDA panel would be positive for shares
