FDA Denies Full Approval for Amgen’s Lung Cancer Drug Lumakras

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AMGEN INC ($NASDAQ:AMGN) is a global biopharmaceutical company that discovers, develops, manufactures and delivers innovative human therapeutics. Recently, the Food and Drug Administration (FDA) has denied full approval for Amgen’s lung cancer drug Lumakras. Lumakras is a treatment designed to target a particular genetic mutation that causes an estimated 10 percent of non-small cell lung cancers. The FDA said that it could not approve the drug with the information presented by Amgen, criticizing the clinical trial for having too few patients and not enough data to determine the safety and efficacy of the drug. This decision may be disappointing to Amgen, but it could mean that this treatment will now have to go through additional testing and trials before it can be approved by the FDA. If approved, Lumakras would be the first therapy of its kind approved in the US specifically for patients with non-small-cell lung cancer that has a particular gene mutation.

The FDA’s decision is a reminder of how difficult the process of getting drugs approved is, especially those that are targeting specific mutations or conditions. Amgen stated that it plans to continue to work with the FDA to address their concerns and get Lumakras approved. In the meantime, they are also working on other treatments for other types of cancer, as well as treatments for rare diseases. They remain hopeful that eventually their efforts will lead to successful approvals from the FDA.

Market Price

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it had denied full approval of Amgen Inc‘s drug Lumakras for treating non-small cell lung cancer. As a result, AMGEN INC’s stock opened at $284.1 and closed at $283.9, down by 0.1% from prior closing price of 284.2. The FDA’s decision has been viewed as a setback for Amgen Inc as Lumakras had been seen as an important potential revenue driver for the company’s portfolio. Amgen Inc had been hoping for full approval of Lumakras as it is the only drug approved by the FDA for treating non-small cell lung cancer in combination with chemotherapy.

The company is now considering its options, including submitting additional data to the FDA in hopes of gaining full approval. It remains to be seen how the FDA’s decision will impact Amgen Inc’s financial results going forward. In the meantime, investors are keeping a close eye on the company as it seeks to regain its footing after this latest setback. Live Quote…

About the Company

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Analysis

GoodWhale conducted an analysis of AMGEN INC‘s fundamentals and the results show that the company is strong in asset, dividend, and profitability, and weak in growth. Our Star Chart indicates that AMGEN INC is relatively healthy, scoring 8/10 in terms of cashflows and debt, meaning that the company is able to pay off debt and fund future operations. We have classified the company as a ‘cow’, a type of company which we determine is capable of paying out consistent and sustainable dividends. Investors interested in this type of company may be those looking for a stable form of income, rather than higher risk investments with higher potential returns. The consistent dividend payout of AMGEN INC may also suit investors who are looking for a steady source of income, such as retirees. Investors focused on short-term gains may also be interested, as the stock generally offers stability. More…

Peers

The competition between Amgen Inc and its competitors is fierce. Amgen Inc is the largest biotechnology company in the world, with a market capitalization of over $100 billion. Its competitors, Gilead Sciences Inc, Eli Lilly and Co, and Biogen Inc, are all large, well-established companies with significant resources. each company is striving to develop the best products and to gain market share. The competition is intense, and each company is working hard to win.

– Gilead Sciences Inc ($NASDAQ:GILD)

Gilead Sciences Inc is a biopharmaceutical company that focuses on the discovery, development, and commercialization of drugs. The company was founded in 1987 and is headquartered in Foster City, California. Gilead Sciences Inc has a market cap of 83.2B as of 2022, a Return on Equity of 24.03%. The company’s key products include HIV/AIDS treatment, hepatitis C treatment, and oncology products. Gilead Sciences Inc also has a pipeline of products in development for various indications, including HIV, hepatitis B, non-alcoholic steatohepatitis, and respiratory syncytial virus.

– Eli Lilly and Co ($NYSE:LLY)

Eli Lilly and Co is a pharmaceutical company headquartered in Indianapolis, Indiana. The company was founded in 1876 by Colonel Eli Lilly. The company develops and markets products in the areas of diabetes, oncology, immunology, neuroscience, and other areas. Lilly has operations in more than 60 countries and sells products in more than 125 countries. Lilly has been one of the world’s leading innovators in the pharmaceutical industry, with products such as Prozac, Zyprexa, and Cialis. The company has a market cap of 316.18B as of 2022 and a Return on Equity of 45.88%.

– Biogen Inc ($NASDAQ:BIIB)

Biogen Inc. is a global biotechnology company. The company is engaged in the discovery, development, manufacturing and commercialization of therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune diseases. Biogen has a market cap of $39.12B as of 2022 and a return on equity of 14.98%. The company’s products include aducanumab, a monoclonal antibody for the treatment of Alzheimer’s disease; SPINRAZA, a therapeutic agent for the treatment of spinal muscular atrophy; and TYSABRI, a monoclonal antibody for the treatment of multiple sclerosis.

Summary

AMGEN INC is a biopharmaceutical company that develops and commercializes human therapeutics. Recently, the company announced that the US Food and Drug Administration (FDA) declined its request for full approval of the lung cancer drug Lumakras. Despite this setback, investors should still consider AMGEN INC as a good buy.

The company has a long history of success in developing innovative treatments and its portfolio includes strong cancer-focused drugs that have proven efficacy in clinical trials. The stock also has a favorable P/E ratio and dividend yield, and is forecasted to have steady earnings growth in the near future.