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Cytokinetics: Clinical Investigators’ Take on ATOMIC-AHF Trial Results (CYTK, $8.01)
Introduction Cytokinetics issued a press release on the results of the phase II trial of ATOMIC-AHF and then held a conference call on September 3. Before the results were discussed in the conference call, news wires reported that the trial had missed its primary endpoint and this caused an immediate sharp sell-off in the stock. […]
Cytokinetics: Previewing the Release of Data from the ATOMIC-AHF Trial of Omecamtiv Mecarbil (CYTK, $9.95)
Investment Overview In my last note, I wrote that I thought the ATOMIC-AHF, phase IIb trial of the intravenous dosage form omecamtiv mecarbil in acute heart failure might not reach its primary endpoint of dyspnea (shortness of breath), but that this would not deter Amgen from beginning phase III trials in 2H, 2014. Wall Street […]
Cytokinetics: A Preview of Key Upcoming Clinical Trial Results (CYTK, $10.17)
Introduction This report is an update on my thinking on Cytokinetics. It should be read in conjunction with earlier reports, especially my initiation report of March 15, Cytokinetics: Critical Phase IIB Data is Upcoming in 2013 for Omecamtiv Mecarbil and Tirasemtiv (CYTK, $6.30). In that report, I first recommended purchase and I continue to do […]
Cytokinetics: Another Positive Deal for Shareholders, This Time with Astellas (CYTK, $11.81)
Cytokinetics (CYTK) has completed its second meaningful deal in two weeks. Today they announced a deal with Astellas (ALPMY) and on June 12, they announced a deal that allows Amgen to develop omecamtiv mecarbil in Japan. Today’s deal brings in $16 million as an upfront milestone and the Amgen (AMGN) deal brought in $15 million […]
Cytokinetics (CYTK, $1.40) Receives a Vote of Confidence from Amgen
Cytokinetics (CYTK) has announced an expansion of the partnering agreement with Amgen (AMGN) for omecamtiv mecarbil, the Company’s lead product which is being developed for congestive heart failure. In the original agreement, rights to omecamtiv in Japan were not included. The expansion gives Amgen rights in Japan as well. Cytokinetics will receive $25 million which […]
Cytokinetics: Key Issues for Beginning Phase III for Omecamtiv Mecarbil in Congestive Heart Failure (CYTK, $1.15)
Overview and Investment Importance Those who read my initiation report on Cytokinetics (CYTK) understand that the importance of successfully conducting a phase III trial for omecamtiv mecarbil and then commercializing the product cannot be overstated. It could bring in as much as $300 million of pre-commercialization milestones from its partner Amgen by mid-2017. In addition, […]
Cytokinetics: Critical Phase IIB Data is Upcoming in 2013 for Omecamtiv Mecarbil and Tirasemtiv (CYTK, Buy. $6.30)
Key Investment Considerations Cytokinetics Has Two Key Drugs in Phase IIb Development Cytokinetics (CYTK) has been the pioneer in developing new drugs based on muscle biology which modulate the mechanics of muscle, particularly those which affect contractility. It has two late stage drugs that will be reading out data on critical phase IIb trials […]
What Will Happen to SmithOnStocks
I want to thank people who expressed their appreciation for my research over the years upon learning that I was refunding subscriptions. Some are wondering what I will do from now on. I do not intend to fade away. I just enjoy learning about new companies and technologies too much. I will keep my website […]
Cytokinetics: Approval of Merck’s Heart Failure Drug Vericiguat Increases My Confidence for Approval of Omecamtiv
The FDA approval of Merck’s new heart failure drug, vericiguat, has meaningful implications for whether it will approve omecamtiv. Vericiguat’s approval meaningfully increases my already strong confidence that the FDA will also approve omecamtiv. The vericiguat trial enrolled 5,050 patients with ejection fractions less than 45. The data underlying its approval is quite similar to […]
A New Note on Cytokinetics with a Focus on Omecamtiv
Cytokinetics and its partner Amgen have guided that topline data from the GALACTIC-HF phase 3 trial of omecamtiv in advanced heart failure will be released in 4Q, 2020. The promise of omecamtiv has been the driving force for my long standing buy recommendation of Cytokinetics and is the overwhelming factor driving the current stock price. […]