Tuesday, October 25, 2022 11:00:18 AM
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.
Recent CYTK News
- Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 05/02/2024 08:00:00 PM
- Cytokinetics to Host Investor Event and Conference Call to Discuss the Primary Results From SEQUOIA-HCM at the European Society of Cardiology Heart Failure 2024 Congress • GlobeNewswire Inc. • 04/29/2024 08:00:00 PM
- Cytokinetics to Announce First Quarter Results on May 8, 2024 • GlobeNewswire Inc. • 04/24/2024 08:00:00 PM
- Cytokinetics Announces Three Late Breaking Clinical Trial Presentations Relating to SEQUOIA-HCM at the European Society of Cardiology Heart Failure 2024 Congress • GlobeNewswire Inc. • 04/10/2024 11:30:00 AM
- Cytokinetics Presents Additional 48-Week Data From FOREST-HCM, the Open Label Extension Clinical Study of Aficamten, at The American College of Cardiology 73ʳᵈ Annual Scientific Session • GlobeNewswire Inc. • 04/05/2024 11:30:00 AM
- Cytokinetics Presents Additional 48-Week Data From FOREST-HCM, the Open Label Extension Clinical Study of Aficamten, at The American College of Cardiology 73ʳᵈ Annual Scientific Session • GlobeNewswire Inc. • 04/05/2024 11:30:00 AM
- Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 04/02/2024 08:00:00 PM
- Cytokinetics to Participate in the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 04/01/2024 08:00:00 PM
- Cytokinetics Announces Four Upcoming Presentations at the American College of Cardiology 73rd Annual Scientific Session • GlobeNewswire Inc. • 03/25/2024 12:15:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 09:26:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 09:24:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 09:22:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/07/2024 09:18:49 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 03/05/2024 09:21:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 09:05:52 PM
- Cytokinetics to Participate in March Investor Conferences • GlobeNewswire Inc. • 03/04/2024 09:00:00 PM
- Super Micro Computer and Deckers Outdoor Set to Join S&P 500; Others to Join S&P 100, S&P MidCap 400 and S&P SmallCap 600 • PR Newswire (US) • 03/01/2024 11:47:00 PM
- Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • GlobeNewswire Inc. • 03/01/2024 09:00:00 PM
- Cytokinetics Joins Global Initiative to Recognize International Rare Disease Day • GlobeNewswire Inc. • 02/29/2024 12:30:00 PM
- Cytokinetics, The Mended Hearts, Inc. and WomenHeart Announce Launch of New Initiative to Increase Engagement in Cardiovascular Clinical Trials • GlobeNewswire Inc. • 02/28/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/27/2024 09:05:22 PM
- Cytokinetics Reports Fourth Quarter 2023 Financial Results • GlobeNewswire Inc. • 02/27/2024 09:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/14/2024 09:04:11 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/14/2024 09:03:41 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 02/13/2024 09:11:12 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM