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Expert Financial Analysis and Reporting

Tag archive for ‘Cytokinetics’

Cytokinetics: Catalysts for 2021 (CYTK, $18.79)

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 […]

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 […]

Cytokinetics: A Deep Dive into the Potential for Omecamtiv (CYTK, Buy, $19.86)

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 […]

Cytokinetics: Is Omecamtiv Mecarbil Approvable? Yes! (CYTK, Buy, $15.59)

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 […]

Cytokinetics: There Still May Be Hope for Omecamtiv Mecarbil (CYTK, Buy, $16.54)

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: Top Line Results for Omecamtiv in GALACTIC-HF Trial Are Perplexing (CYTK, $15.46)

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: […]

Cytokinetics: Proposed Acquisition Price for MyoKardia Suggests CYTK is Dramatically Undervalued (CYTK, Buy, $27.33)

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 […]

Cytokinetics (CYTK, Buy, $20.97) Omecamtiv Nears the Finish Line; Topline Data Expected in 4Q, 2020 with Launch Possible in 2021

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 […]

Cytokinetics: Current Investment Thesis Is All About Omecamtiv Mecarbil (CYTK. $13.26, Buy)

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 […]

Cytokinetics: Based on Data from Fortitude ALS Trial, Cytokinetics and Astellas Indicate They Will Undertake Phase 3 Trial of Reldesemtiv in ALS (CYTK, Buy, $9.30)

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 […]