Cytokinetics Intrinsic Value Calculation – US FDA Issues Complete Response Letter to Cytokinetics, Shares Down 8% Post-Market Trading.

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Cytokinetics Intrinsic Value Calculation – The biopharmaceutical firm Cytokinetics ($NASDAQ:CYTK) recently received a major setback when the US Food and Drug Administration (FDA) issued a Complete Response Letter regarding their heart failure drug, omecamtiv mecarbil. This news caused the stock price of Cytokinetics to take a swift 8% downturn in post-market trading. The Complete Response Letter from the FDA points to an overall disapproval of the application package submitted by Cytokinetics for approval of omecamtiv mecarbil as an effective therapy for treating heart failure. The agency has not provided any specific details about why their application was rejected, but it is clear that Cytokinetics’ hopes for approval have been dashed.

This news comes as a major blow to Cytokinetics and their shareholders, who had high expectations for approval. The rejection of the application has caused a considerable decrease in post-market trading of the company’s shares, and it is yet to be seen what kind of impact this will have on the future of the firm. In light of this news, it remains to be seen what path Cytokinetics will take moving forward with omecamtiv mecarbil, as well as their other products in development. For now, investors are closely watching the performance of the company’s stock following this latest announcement from the FDA.

Share Price

Tuesday proved to be a difficult day for Cytokinetics as the United States Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the biopharmaceutical company. This announcement came after the market closed, and resulted in a 8% drop in Cytokinetics stock price in aftermarket trading. At market opening, CYTOKINETICS stock opened at $42.8 and closed at $43.4, up by 0.9% from prior closing price of 43.0. The CRL came as a surprise to many investors and shareholders of Cytokinetics, as the company had submitted a New Drug Application (NDA) for its drug, Rytary.

Rytary was developed to treat patients with Parkinson’s disease. The CRL conveyed the FDA’s message that Cytokinetics did not provide sufficient evidence that Rytary is safe and effective for its FDA-approved use. Live Quote…

About the Company

Income Snapshot

Below shows the total revenue, net income and net margin for Cytokinetics. More…

Cash Flow Snapshot

Below shows the cash from operations, investing and financing for Cytokinetics. More…

Balance Sheet Snapshot

Below shows the total assets, liabilities and book value per share for Cytokinetics. More…

Key Ratios Snapshot

Some of the financial key ratios for Cytokinetics are shown below. More…

Analysis – Cytokinetics Intrinsic Value Calculation

At GoodWhale, we have conducted an in-depth analysis of CYTOKINETICS‘s financial performance and have determined that, at a fair value of $55.3, the company’s shares are currently being undervalued by 21.5%. We arrived at this conclusion after running our proprietary Valuation Line on the publicly available financial information of CYTOKINETICS. This means that the shares, which are currently trading at $43.4, offer a great opportunity for long-term investors to purchase a discounted stake in the company. We believe that CYTOKINETICS’s financials support a continued long-term growth trajectory through product expansion, which should lead to greater upside in the stock in the future. More…

Peers

The company’s main competitors are Rubius Therapeutics Inc, XSpray Pharma AB, and Proteo Inc.

– Rubius Therapeutics Inc ($NASDAQ:RUBY)

Rubius Therapeutics Inc is a clinical-stage biopharmaceutical company focused on the development of a new class of therapeutics called Red Cell Therapeutics (RCTs). RCTs are living medicines that are derived from red blood cells and have the potential to treat a wide range of diseases with a single administration. The company’s lead product candidate, RTX-134, is in development for the treatment of severe combined immunodeficiency (SCID), a rare and potentially fatal genetic disease. Rubius has completed a Phase 1/2 clinical trial of RTX-134 in SCID patients and is preparing for a Phase 3 clinical trial.

Rubius has a market capitalization of $31.69 million and a negative return on equity of 105.38%. The company’s lead product candidate, RTX-134, is in development for the treatment of severe combined immunodeficiency (SCID), a rare and potentially fatal genetic disease. Rubius has completed a Phase 1/2 clinical trial of RTX-134 in SCID patients and is preparing for a Phase 3 clinical trial.

– XSpray Pharma AB ($LTS:0GHZ)

Spray Pharma AB is a pharmaceutical company with a market cap of 1.28B as of 2022. The company has a Return on Equity of -12.71%. Spray Pharma AB focuses on the development and commercialization of drugs for the treatment of rare diseases.

Summary

CYTOKINETICS, Inc. has seen a 8% dip in its stock value following the US FDA’s issuance of a Complete Response Letter. The letter was in regards to the company’s application for its drug omecamtiv mecarbil, which was being evaluated for the treatment of heart failure. As an investing analysis, it is important to consider the financial implications this response will have on the company, as well as investigate any potential opportunities that may arise from the situation.

Analysts should also evaluate the impact this will have on other related drugs in development, as well as how the letter might affect potential partnerships with other pharmaceutical companies. Ultimately, investors will want to decide whether or not this incident affects the company’s long-term prospects.