FDA Panel Rejects Merck’s Cough Therapy Proposal

November 22, 2023

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An FDA panel has rejected Merck ($NYSE:MRK)’s proposal for a new cough therapy. This marks a major setback for the pharmaceutical giant Merck, which is one of the world’s leading research-driven healthcare companies. Merck develops, manufactures and sells prescription medicines, vaccines, biologic therapies and animal health related products. Its stock is traded on the New York Stock Exchange (NYSE) and is part of the Dow Jones Industrial Average.

The proposed therapy from Merck aimed to treat chronic cough in adults, however the FDA panel decided not to approve it. The panel cited safety concerns, including potential liver damage, as the main reason for their decision. Merck is now under pressure to provide more data on the safety and efficacy of the therapy in order to gain approval.

Stock Price

Despite the news, MERCK shares opened at $101.0 and closed at $102.7, representing a 0.9% increase from its closing price of $101.8 the previous day. The panel’s recommendation will need to be finalized by the FDA before any action is taken, however the news has left many investors uncertain about the future prospects of MERCK’s proposed therapy. Live Quote…

About the Company

  • Mercks_Cough_Therapy_Proposal”>Industry Classification
  • Key Executives
  • Ownership (Institutional/ Fund Holdings)
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  • Income Snapshot

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

    Total Revenues Net Income Net Margin
    59.31k 4.61k 8.3%
  • Income Statement Reports (Yearly/ Quarterly/ LTM)
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  • Growth Performance
  • Cash Flow Snapshot

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

    Operations Investing Financing
    15.07k -4.96k -9.12k
  • Cash Flow Statement (Yearly/ Quarterly/ LTM)
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  • Balance Sheet Snapshot

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

    Total Assets Total Liabilities Book Value Per Share
    104.47k 65.73k 15.25
  • Balance Sheet (Yearly/ Quarterly)
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  • Key Ratios Snapshot

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

    3Y Rev Growth 3Y Operating Profit Growth Operating Margin
    7.8% -14.8% 14.2%
    FCF Margin ROE ROA
    18.3% 13.6% 5.0%
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  • Analysis

    At GoodWhale, we conducted a fundamental analysis of MERCK and using the Star Chart, we concluded that MERCK is strong in dividend, profitability, and medium in asset. Sadly, it is weak in growth. We classify MERCK as ‘cows’, companies that have consistently paid out sustainable dividends. Investors who are looking for reliable, steady income and a low-risk investment may find MERCK an attractive option. In addition, our health score of 8/10 provides assurance that MERCK is capable of sustaining future operations even in times of crisis. Ultimately, MERCK offers a safe and stable investment opportunity despite its weak growth prospects. More…

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  • Peers

    In the pharmaceutical industry, Merck & Co Inc is up against some stiff competition. Sanofi SA, Roche Holding AG, and TherapeuticsMD Inc are all major players in the industry. While each company has its own strengths and weaknesses, they all compete against each other to bring new and innovative drugs to market.

    – Sanofi SA ($LTS:0O59)

    As of 2022, Sanofi SA has a market capitalization of 102.29 billion euros and a return on equity of 7.56%. The company is a French multinational pharmaceutical company headquartered in Paris, France, and is one of the world’s largest pharmaceutical companies. Sanofi is a diversified company, with operations in several therapeutic areas, including diabetes, vaccines, rare diseases, multiple sclerosis, oncology, immunology, and cardiovascular.

    – Roche Holding AG ($LTS:0TDF)

    Roche Holding AG, a Swiss multinational healthcare company, has a market cap of 270.34B as of 2022. The company’s Return on Equity is 47.83%. Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. The company provides medicines and diagnostic tests that enable personalized health care for patients.

    – TherapeuticsMD Inc ($NASDAQ:TXMD)

    TherapeuticsMD Inc. is a biopharmaceutical company, which focuses on developing and commercializing products for the health and well-being of women. It offers products in various therapeutic areas, such as Menopause, Osteoporosis, Chronic Vulvar and Vaginal Atrophy, and other health conditions related to hormone deficiency and imbalances. The company was founded by Robert G. Finizio, George S. Paletta, and Douglas S. Leighton in 2010 and is headquartered in Boca Raton, FL.

    Summary

    Merck, a major pharmaceutical company, recently failed to win approval from a U.S. Food and Drug Administration (FDA) panel for a new cough therapy. This is a setback as the therapy had been seen as a potential major new source of revenue for Merck. Despite this news, Merck remains a viable investment option for investors, due to its strong balance sheet, long history of innovating and launching successful drugs, and commitment to maintaining dividend payments.

    The company has also recently invested in cutting-edge technologies that are likely to add value in the future. Investors should continue to closely monitor Merck’s developments and weigh their risk appetite when deciding whether or not to invest in the company.

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