J&J Submits sBLA to FDA for Rybrevant Combination Therapy in Non-Small Cell Lung Cancer

December 22, 2023

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Johnson & Johnson ($NYSE:JNJ) (J&J) is a multinational healthcare company that develops and sells a wide range of medical products, including pharmaceuticals, consumer packaged goods, and medical devices. Listed on the New York Stock Exchange, it is one of the world’s most valuable companies. Recently, J&J submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Rybrevant in combination with chemotherapy for the treatment of non-small cell lung cancer. The FDA’s acceptance of J&J’s sBLA means that Rybrevant may soon be approved as a treatment option for those suffering from non-small cell lung cancer.

If approved, it could become an important combination therapy option in the management of this disease. It would be a great achievement for J&J, as well as for those suffering from non-small cell lung cancer who may soon have access to a potentially effective treatment.

Share Price

On Thursday, JOHNSON & JOHNSON stock opened at $153.7 and closed at $154.8, up by 1.0% from the previous closing price of 153.3. This increase in share prices was due to the company’s submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for their Rybrevant combination therapy for metastatic non-small cell lung cancer (NSCLC). Such approval would expand the current indications for using Rybrevant in NSCLC patients. Live Quote…

About the Company

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  • Income Snapshot

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

    Total Revenues Net Income Net Margin
    98.66k 34.62k 13.3%
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    Below shows the cash from operations, investing and financing for JNJ. More…

    Operations Investing Financing
    23.42k -6.19k -18.02k
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  • Balance Sheet Snapshot

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

    Total Assets Total Liabilities Book Value Per Share
    179.23k 108.96k 29.19
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  • Key Ratios Snapshot

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

    3Y Rev Growth 3Y Operating Profit Growth Operating Margin
    6.9% 7.9% 24.4%
    FCF Margin ROE ROA
    24.3% 21.4% 8.4%
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  • Analysis

    At GoodWhale we have done a full financial analysis of JOHNSON & JOHNSON. Our Star Chart gives JOHNSON & JOHNSON a strong rating for dividends, profitability, and a medium rating for assets. Growth is the only area where they are weak. In terms of overall health, our score for JOHNSON & JOHNSON is 9/10. This takes into consideration the company’s cashflows and debt, and how they are able to pay off debt and fund future operations. Given all these factors, we have classified JOHNSON & JOHNSON as a ‘cow’, a company with a track record of paying out consistent and sustainable dividends. Investors who are looking for long-term, stable investments may find JOHNSON & JOHNSON to be an attractive option. More…

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  • Peers

    The competition between Johnson & Johnson and its competitors is fierce. AstraZeneca PLC, Pfizer Inc, and BioNTech SE are all major players in the pharmaceutical industry, and they are all vying for a piece of the pie. Johnson & Johnson is a well-established company with a long history of success, but its competitors are not to be underestimated. They are all large, well-funded companies with a lot to lose if they don’t win the competition.

    – AstraZeneca PLC ($LSE:AZN)

    AstraZeneca PLC is a biopharmaceutical company with a market cap of 152.13B as of 2022. The company focuses on the discovery, development, and commercialization of small molecule drugs in the areas of oncology, cardiovascular, and renal & metabolism. The company’s ROE for the year ended December 31, 2020 was -0.94%.

    – Pfizer Inc ($NYSE:PFE)

    Pfizer Inc is a pharmaceutical company with a market cap of 240.55B as of 2022. The company has a return on equity of 24.63%. Pfizer Inc is a research-based, global pharmaceutical company that discovers, develops, manufactures, and markets medicines for humans and animals. The company’s products include prescription and over-the-counter medicines, vaccines, and biologic therapies.

    – BioNTech SE ($NASDAQ:BNTX)

    BioNTech SE is a German biotech company founded in 2008 that focuses on the development of Innovation therapies against cancer and other serious diseases. The company has a market cap of 32.91B as of 2022 and a Return on Equity of 71.82%. BioNTech’s mission is to revolutionize the treatment of cancer and other serious diseases by leveraging the power of the immune system. The company is developing a portfolio of immunotherapy products based on its proprietary mRNA technology platform.

    Summary

    Johnson & Johnson (J&J) recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for its Rybrevant combination therapy in non-small cell lung cancer (NSCLC). If approved, the drug combination may offer an alternative treatment option to patients with advanced NSCLC who have certain genetic mutations. J&J’s stock price could increase with the FDA’s approval of Rybrevant, making it an attractive option for investors seeking to benefit from a potential break-through therapy. Other factors investors should consider when evaluating J&J stock include their diversified product portfolio, strong financial performance, and excellent track record in research and development.

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