Expert Financial Analysis and Reporting

Introduction I have shut down the subscription service for SmithOnStocks and have refunded subscription fees for those subscribers who paid their annual subscription fee in the period from August 2020 to February 2021. My payments provider, PayPal, didn’t allow for refunds to subscribers who paid in the March 2020 to July 2020 period. Those subscribers […]

Investment Overview Cytokinetics has three highly valuable pipeline assets whose aggregate value in my view substantially exceeds its current market valuation of $1.4 billion: Omecamtiv mecarbil just completed the GALACTIC-HF phase 3 trial in heart failure. The trial met its primary endpoint with a p value of 0.025 and there were no safety issues, but […]

Key Points of the GALACIC-HF Trial Cytokinetics declined sharply after it announced topline results in the huge 8,500 patient phase 3 GALACTIC-HF trial of omecamtiv mecarbil in congestive heart failure. The study successfully reached the primary endpoint of time to cardiovascular death or first heart failure event with a p-value of 0.025 and a hazard […]

Investment Opinion Data presented at the upcoming American Heart Association meeting on the phase 3 GALACTIC-HG trial on omecamtiv mecarbil could cause a sharp swing in the stock. The data could make investors more positive on the commercial potential of omecamtiv mecarbil in which case we could see a sharp upward move. Also possible is […]

Cytokinetics reported that the results of GALACTIC-HF show that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and demonstrated a statistically significant effect to reduce cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care (HR: […]

Bristol-Myers Squibb has announced that it will acquire MyoKardia for $13.1 billion in cash and this has important implications for Cytokinetics. These companies have technologies that activate or inhibit muscle activation. To my knowledge they are the only two companies that have products in clinical development based on this technology. Interestingly, MyoKardia acquired technology from […]

Overview Cytokinetics was founded 22 years ago and has not deviated from its initial business model that is based on an understanding of muscle activation and inhibition in cardiac and skeletal muscle. Finally, the company may be poised for the commercial introduction of its lead drug, omecamtiv. Even by biotechnology standards, the development of omecamtiv […]

Investment Thesis is Almost Exclusively Driven by Prospects for Omecamtiv Mecarbil Omecamtiv Mecarbil is a Potential Mega- Blockbuster Omecamtiv mecarbil is one of the most exciting drugs in development in all of biopharma and is the primary driver of my investment thesis on Cytokinetics. If successful in the ongoing, phase 3 GALACTIC-HF trial, I believe […]

Key Points: Trial missed achieving statistical significance on primary endpoint of slow vital capacity Still, key opinion leaders when looking at the totality of data are strongly supportive of launching a phase 3 trial Management has not yet issued guidance, but my guess is that the trial could begin in late 2019 and conclude in […]

There has been strong price action today in both Cryoport and Cytokinetics so I thought I would make a brief comment on each. At the time of this writing, the intraday price of CYTK is up $1.34 to $9.86 and since March 7, 2019 it is up 64% from $6.02. On March 7, 2019 CYTK […]