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H2R

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Tuesday, 10/25/2022 11:00:13 AM

Tuesday, October 25, 2022 11:00:13 AM

Post# of 1569
SA Article

CM in Q4 of 2022. With proof of concept established with omecamtiv mecarbil for heart failure, plus several catalysts expected within a year, these are the reasons why I believe that Cytokinetics is a great speculative biotech play to look into.

Omecamtiv Mecarbil Holds Great Potential With A Few Catalysts
The main drug in the pipeline for Cytokinetics would be omecamtiv mecarbil. That's because not only has it established proof of concept by meeting the primary composite endpoint for the phase 3 GALACTIC-HF study, but it now has two catalysts on the way which traders/investors can focus on. Before going over these catalysts though, it's important to highlight why the biotech was able to move on to file a New Drug Application (NDA) to the FDA. The reason again is because of the impressive results it was able to obtain from the late-stage GALACTIC-HF study. There was a total of 8,256 patients who were recruited that were at risk of hospitalization or death, despite still receiving ongoing standard of care (SOC) therapy. It was noted that omecamtiv mecarbil met on the primary composite endpoint compared to placebo. That is, treatment with Omecamtiv mecarbil reduced the risk of cardiovascular death or heart failure events compared to placebo (patients who received standard of care). With this primary composite endpoint being met, it now provides Cytokinetics the avenue to move towards possible FDA approval. It has already met with the FDA and because additional data was sent to the agency, it needed additional time to review it. Thus, one major catalyst which investors can look forward to would be the PDUFA date established for omecamtiv mecarbil for the treatment of heart failure patients, which is set for February 28, 2023. That's not the only catalyst which investors have to look forward to either. Before this FDA final decision for omecamtiv, the FDA advisory panel committee is going to review the drug first on December 13, 2022. If the advisory committee review goes well, plus the FDA chooses to ultimately approve it for marketing of this heart failure indication, then the expected launch would happen in Q1 of 2023.
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